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Details

Stereochemistry RACEMIC
Molecular Formula C17H18F3NO
Molecular Weight 309.3268
Optical Activity ( + / - )
Defined Stereocenters 0 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of FLUOXETINE

SMILES

CNCCC(c1ccccc1)Oc2ccc(cc2)C(F)(F)F

InChI

InChIKey=RTHCYVBBDHJXIQ-UHFFFAOYSA-N
InChI=1S/C17H18F3NO/c1-21-12-11-16(13-5-3-2-4-6-13)22-15-9-7-14(8-10-15)17(18,19)20/h2-10,16,21H,11-12H2,1H3

HIDE SMILES / InChI

Molecular Formula C17H18F3NO
Molecular Weight 309.3268
Charge 0
Count
Stereochemistry RACEMIC
Additional Stereochemistry No
Defined Stereocenters 0 / 1
E/Z Centers 0
Optical Activity ( + / - )

Fluoxetine hydrochloride is the first agent of the class of antidepressants known as selective serotonin-reuptake inhibitors (SSRIs). Fluoxetine is a racemic mixture of the R- and S- enantiomers and are of equivalent pharmacologic activity. Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Fluoxetine is marketed under the trade names Prozac and Sarafem among others. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). PROZAC is a selective serotonin reuptake inhibitor indicated for: • Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years • Acute and maintenance treatment of Bulimia Nervosa in adult patients • Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients. Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine. Antagonism of muscarinic, histaminergic, and α1-adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of classical tricyclic antidepressant (TCA) drugs. Fluoxetine binds to these and other membrane receptors from brain tissue much less potently in vitro than do the tricyclic drugs.

Originator

Curator's Comment:: # Eli Lilly

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
PROZAC

Approved Use

Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) Fluoxetine and olanzapine in combination for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) 1.1 Major Depressive Disorder Fluoxetine hydrochloride is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see CLINICAL STUDIES (14.1)

Launch Date

5.6773437E11
Primary
PROZAC

Approved Use

Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) Fluoxetine and olanzapine in combination for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) 1.1 Major Depressive Disorder Fluoxetine hydrochloride is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see CLINICAL STUDIES (14.1)

Launch Date

5.6773437E11
Primary
PROZAC

Approved Use

Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) Fluoxetine and olanzapine in combination for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) 1.1 Major Depressive Disorder Fluoxetine hydrochloride is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see CLINICAL STUDIES (14.1)

Launch Date

5.6773437E11
Primary
PROZAC

Approved Use

Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) Fluoxetine and olanzapine in combination for: Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1.5) 1.1 Major Depressive Disorder Fluoxetine hydrochloride is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see CLINICAL STUDIES (14.1)

Launch Date

5.6773437E11
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
22.56 ng/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUOXETINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
13576.38 pg/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUOXETINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
1101.46 ng × h/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUOXETINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
788626.72 pg × h/mL
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUOXETINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
46.39 h
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUOXETINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
49.7 h
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FLUOXETINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
5.5%
FLUOXETINE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
240 mg single, oral
Overdose
Dose: 240 mg
Route: oral
Route: single
Dose: 240 mg
Sources:
unhealthy, 12 - 19 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 12 - 19 years
Sex: unknown
Population Size: 2
Sources:
280 mg single, oral
Overdose
Dose: 280 mg
Route: oral
Route: single
Dose: 280 mg
Sources:
unhealthy, 14 - 19 years
n = 3
Health Status: unhealthy
Condition: mental disorders
Age Group: 14 - 19 years
Sex: unknown
Population Size: 3
Sources:
Disc. AE: Sleepy, Tremor...
AEs leading to
discontinuation/dose reduction:
Sleepy (1 patient)
Tremor (1 patient)
Sources:
260 mg single, oral
Overdose
Dose: 260 mg
Route: oral
Route: single
Dose: 260 mg
Sources:
unhealthy, 15 - 25 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 15 - 25 years
Sex: unknown
Population Size: 2
Sources:
Disc. AE: Sleepy...
AEs leading to
discontinuation/dose reduction:
Sleepy (1 patient)
Sources:
200 mg single, oral
Overdose
Dose: 200 mg
Route: oral
Route: single
Dose: 200 mg
Sources:
unhealthy, 15 - 40 years
n = 6
Health Status: unhealthy
Condition: mental disorders
Age Group: 15 - 40 years
Sex: unknown
Population Size: 6
Sources:
Disc. AE: Insomnia...
AEs leading to
discontinuation/dose reduction:
Insomnia (1 patient)
Sources:
320 mg single, oral
Overdose
Dose: 320 mg
Route: oral
Route: single
Dose: 320 mg
Sources:
unhealthy, 15 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 15 years
Sex: unknown
Population Size: 1
Sources:
340 mg single, oral
Overdose
Dose: 340 mg
Route: oral
Route: single
Dose: 340 mg
Sources:
unhealthy, 18 - 22 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 18 - 22 years
Sex: unknown
Population Size: 2
Sources:
Disc. AE: Hypertension...
AEs leading to
discontinuation/dose reduction:
Hypertension (grade 1, 1 patient)
Sources:
140 mg single, oral
Overdose
Dose: 140 mg
Route: oral
Route: single
Dose: 140 mg
Sources:
unhealthy, 18 - 42 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 18 - 42 years
Sex: unknown
Population Size: 2
Sources:
Disc. AE: Sleepy...
AEs leading to
discontinuation/dose reduction:
Sleepy (1 patient)
Sources:
800 mg single, oral
Overdose
Dose: 800 mg
Route: oral
Route: single
Dose: 800 mg
Sources:
unhealthy, 18 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 18 years
Sex: unknown
Population Size: 1
Sources:
Disc. AE: Hypertension...
AEs leading to
discontinuation/dose reduction:
Hypertension (grade 2, 1 patient)
Sources:
600 mg single, oral
Overdose
Dose: 600 mg
Route: oral
Route: single
Dose: 600 mg
Sources:
unhealthy, 20 - 45 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 20 - 45 years
Sex: unknown
Population Size: 2
Sources:
Disc. AE: Hypertension, Sleepy...
AEs leading to
discontinuation/dose reduction:
Hypertension (grade 3, 1 patient)
Sleepy (1 patient)
Sources:
1000 mg single, oral
Overdose
Dose: 1000 mg
Route: oral
Route: single
Dose: 1000 mg
Sources:
unhealthy, 21 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 21 years
Sex: unknown
Population Size: 1
Sources:
1500 mg single, oral
Overdose
Dose: 1500 mg
Route: oral
Route: single
Dose: 1500 mg
Sources:
unhealthy, 21 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 21 years
Sex: unknown
Population Size: 1
Sources:
500 mg single, oral
Overdose
Dose: 500 mg
Route: oral
Route: single
Dose: 500 mg
Sources:
unhealthy, 28 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 28 years
Sex: unknown
Population Size: 1
Sources:
Disc. AE: Sore throat...
AEs leading to
discontinuation/dose reduction:
Sore throat (1 patient)
Sources:
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 29 - 46 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 29 - 46 years
Sex: unknown
Population Size: 2
Sources:
Disc. AE: Ataxic, Sleepy...
AEs leading to
discontinuation/dose reduction:
Ataxic (1 patient)
Sleepy (1 patient)
Sources:
400 mg single, oral
Overdose
Dose: 400 mg
Route: oral
Route: single
Dose: 400 mg
Sources:
unhealthy, 31 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 31 years
Sex: unknown
Population Size: 2
Sources:
700 mg single, oral
Overdose
Dose: 700 mg
Route: oral
Route: single
Dose: 700 mg
Sources:
unhealthy, 36 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 36 years
Sex: unknown
Population Size: 1
Sources:
Disc. AE: GI pain...
AEs leading to
discontinuation/dose reduction:
GI pain (1 patient)
Sources:
120 mg single, oral
Overdose
Dose: 120 mg
Route: oral
Route: single
Dose: 120 mg
Sources:
unhealthy, 42 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 42 years
Sex: unknown
Population Size: 1
Sources:
640 mg single, oral
Overdose
Dose: 640 mg
Route: oral
Route: single
Dose: 640 mg
Sources:
unhealthy, 50 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 50 years
Sex: unknown
Population Size: 1
Sources:
Disc. AE: Sleepy...
AEs leading to
discontinuation/dose reduction:
Sleepy (1 patient)
Sources:
1120 mg single, oral
Overdose
Dose: 1120 mg
Route: oral
Route: single
Dose: 1120 mg
Sources:
unhealthy, 51 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 51 years
Sex: unknown
Population Size: 1
Sources:
Disc. AE: Nausea...
AEs leading to
discontinuation/dose reduction:
Nausea (1 patient)
Sources:
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Other AEs: Intentional overdose, Suicide attempt...
Other AEs:
Intentional overdose (serious, 1 patient)
Suicide attempt (serious, 1 patient)
Suicidal ideation (serious, 1 patient)
Faecaloma (serious, 1 patient)
Tachycardia (below serious, 5 patients)
Vomiting (below serious, 4 patients)
Nasopharyngitis (below serious, 7 patients)
Decreased appetite (below serious, 10 patients)
Sources:
80 mg 1 times / day steady, oral (max)
Dose: 80 mg, 1 times / day
Route: oral
Route: steady
Dose: 80 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 25
Health Status: unhealthy
Condition: Body Dysmorphic Disorder
Age Group: adolescent
Population Size: 25
Sources:
Other AEs: Suicidal behavior, Pain stomach...
Other AEs:
Suicidal behavior (serious, 1 patient)
Pain stomach (below serious, 2 patients)
Insomnia (below serious, 1 patient)
Fatigue (below serious, 1 patient)
Sources:
544 mg single, oral (mean)
Overdose
Dose: 544 mg
Route: oral
Route: single
Dose: 544 mg
Sources:
unhealthy, adult
n = 37
Health Status: unhealthy
Condition: mental disorders
Age Group: adult
Sex: unknown
Population Size: 37
Sources:
Disc. AE: Tachycardia, Drowsiness...
AEs leading to
discontinuation/dose reduction:
Tachycardia (15 patients)
Drowsiness (14 patients)
Tremor (5 patients)
Vomited (4 patients)
Nausea (4 patients)
Sources:
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Other AEs: Asthenia, Vasodilatation...
Other AEs:
Asthenia (7%)
Vasodilatation (1%)
Nausea (12%)
Diarrhea (9%)
Anorexia (5%)
Dry mouth (5%)
Dyspepsia (6%)
Insomnia (10%)
Anxiety (6%)
Nervousness (8%)
Somnolence (5%)
Tremor (3%)
Libido decreased (1%)
Abnormal dreams (1%)
Yawn (1%)
Sweating (2%)
Rash (2%)
Sources:
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Other AEs: Asthenia, Vasodilatation...
Other AEs:
Asthenia (9%)
Vasodilatation (3%)
Nausea (21%)
Diarrhea (12%)
Anorexia (11%)
Dry mouth (10%)
Dyspepsia (7%)
Insomnia (16%)
Anxiety (12%)
Nervousness (14%)
Somnolence (13%)
Tremor (10%)
Libido decreased (3%)
Abnormal dreams (1%)
Sweating (8%)
Rash (4%)
Sources:
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Other AEs: Asthenia, Vasodilatation...
Other AEs:
Asthenia (15%)
Vasodilatation (5%)
Nausea (26%)
Diarrhea (18%)
Anorexia (17%)
Dry mouth (12%)
Dyspepsia (10%)
Insomnia (28%)
Anxiety (14%)
Nervousness (14%)
Somnolence (17%)
Tremor (9%)
Libido decreased (11%)
Abnormal dreams (5%)
Yawn (7%)
Sweating (7%)
Rash (6%)
Sources:
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Other AEs: Headache, Asthenia...
Other AEs:
Headache (22%)
Asthenia (18%)
Nausea (18%)
Rhinitis (17%)
Diarrhoea (15%)
Somnolence (13%)
Insomnia (12%)
Nervousness (10%)
Sweating (9%)
Flu syndrome (8%)
Pain (7%)
Anxiety (7%)
Dizziness (6%)
Tremor (6%)
Pharyngitis (5%)
Sources:
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Other AEs: Asthenia, Vasodilatation...
Other AEs:
Asthenia (21%)
Vasodilatation (2%)
Nausea (29%)
Diarrhea (8%)
Anorexia (8%)
Dry mouth (9%)
Dyspepsia (10%)
Insomnia (33%)
Anxiety (15%)
Nervousness (11%)
Somnolence (13%)
Tremor (13%)
Libido decreased (5%)
Abnormal dreams (5%)
Yawn (11%)
Sweating (8%)
Rash (4%)
Sources:
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, children
n = 228
Health Status: unhealthy
Condition: mental disorders
Age Group: children
Sex: unknown
Population Size: 228
Sources:
Other AEs: Hypomania...
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Other AEs: Depressive symptom, Hallucination, auditory...
Other AEs:
Depressive symptom (serious, 1 patient)
Hallucination, auditory (serious, 1 patient)
Overdose (serious, 1 patient)
Suicidal ideation (serious, 3 patients)
Abdominal pain upper (below serious, 4 patients)
Upper respiratory tract infection (below serious, 5 patients)
Insomnia (below serious, 6 patients)
Sources:
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Other AEs: Suicidal ideation, Suicide attempt...
Other AEs:
Suicidal ideation (serious, 1 patient)
Suicide attempt (serious, 1 patient)
Abdominal pain upper (below serious, 9 patients)
Nausea (below serious, 13 patients)
Vomiting (below serious, 7 patients)
Fatigue (below serious, 6 patients)
Influenza (below serious, 2 patients)
Sources:
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Other AEs: Lymphadenitis, Gastritis...
Other AEs:
Lymphadenitis (serious, 1 patient)
Gastritis (serious, 1 patient)
Ulna fracture (serious, 1 patient)
Nausea (below serious, 15 patients)
Vomiting (below serious, 6 patients)
Upper respiratory tract infection (below serious, 3 patients)
Incorrect dose administered (below serious, 4 patients)
Decreased appetite (below serious, 10 patients)
Dizziness (below serious, 4 patients)
Headache (below serious, 18 patients)
Insomnia (below serious, 6 patients)
Sources:
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
healthy
n = 8
Health Status: healthy
Sex: M
Population Size: 8
Sources:
Other AEs: Blood triglycerides increased...
Other AEs:
Blood triglycerides increased (below serious, 1 patient)
Sources:
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Other AEs: Diarrhoea, Stomatitis...
Other AEs:
Diarrhoea (below serious, 1 patient)
Stomatitis (below serious, 1 patient)
Alanine aminotransferase increased (below serious, 2 patients)
Aspartate aminotransferase increased (below serious, 1 patient)
Sources:
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
n = 46
Health Status: unhealthy
Condition: Depression
Sex: F
Population Size: 46
Sources:
Other AEs: Headache, Anxiety...
Other AEs:
Headache (below serious, 6 patients)
Anxiety (below serious, 8 patients)
Dizziness (below serious, 5 patients)
Sources:
40 mg single, oral
Dose: 40 mg
Route: oral
Route: single
Dose: 40 mg
Sources:
healthy
n = 8
Health Status: healthy
Sex: M
Population Size: 8
Sources:
Other AEs: White blood cell count decreased...
Other AEs:
White blood cell count decreased (below serious, 2 patients)
Sources:
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Other AEs: Atrioventricular block first degree, Conjunctivitis allergic...
Other AEs:
Atrioventricular block first degree (below serious, 2 patients)
Conjunctivitis allergic (below serious, 1 patient)
Haemorrhoids (below serious, 1 patient)
Proctalgia (below serious, 1 patient)
Excoriation (below serious, 1 patient)
Alanine aminotransferase increased (below serious, 1 patient)
Aspartate aminotransferase increased (below serious, 1 patient)
Blood triglycerides increased (below serious, 1 patient)
White blood cell count decreased (below serious, 1 patient)
White blood cell count increased (below serious, 1 patient)
Dizziness (below serious, 1 patient)
Anxiety (below serious, 1 patient)
Sources:
80 mg 1 times / day steady, oral (max)
Dose: 80 mg, 1 times / day
Route: oral
Route: steady
Dose: 80 mg, 1 times / day
Sources:
unhealthy
n = 49
Health Status: unhealthy
Condition: Anorexia Nervosa
Sex: F
Population Size: 49
Sources:
Other AEs: Suicide attempt...
Other AEs:
Suicide attempt (serious, 1 patient)
Sources:
AEs

AEs

AESignificanceDosePopulation
Sleepy 1 patient
Disc. AE
280 mg single, oral
Overdose
Dose: 280 mg
Route: oral
Route: single
Dose: 280 mg
Sources:
unhealthy, 14 - 19 years
n = 3
Health Status: unhealthy
Condition: mental disorders
Age Group: 14 - 19 years
Sex: unknown
Population Size: 3
Sources:
Tremor 1 patient
Disc. AE
280 mg single, oral
Overdose
Dose: 280 mg
Route: oral
Route: single
Dose: 280 mg
Sources:
unhealthy, 14 - 19 years
n = 3
Health Status: unhealthy
Condition: mental disorders
Age Group: 14 - 19 years
Sex: unknown
Population Size: 3
Sources:
Sleepy 1 patient
Disc. AE
260 mg single, oral
Overdose
Dose: 260 mg
Route: oral
Route: single
Dose: 260 mg
Sources:
unhealthy, 15 - 25 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 15 - 25 years
Sex: unknown
Population Size: 2
Sources:
Insomnia 1 patient
Disc. AE
200 mg single, oral
Overdose
Dose: 200 mg
Route: oral
Route: single
Dose: 200 mg
Sources:
unhealthy, 15 - 40 years
n = 6
Health Status: unhealthy
Condition: mental disorders
Age Group: 15 - 40 years
Sex: unknown
Population Size: 6
Sources:
Hypertension grade 1, 1 patient
Disc. AE
340 mg single, oral
Overdose
Dose: 340 mg
Route: oral
Route: single
Dose: 340 mg
Sources:
unhealthy, 18 - 22 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 18 - 22 years
Sex: unknown
Population Size: 2
Sources:
Sleepy 1 patient
Disc. AE
140 mg single, oral
Overdose
Dose: 140 mg
Route: oral
Route: single
Dose: 140 mg
Sources:
unhealthy, 18 - 42 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 18 - 42 years
Sex: unknown
Population Size: 2
Sources:
Hypertension grade 2, 1 patient
Disc. AE
800 mg single, oral
Overdose
Dose: 800 mg
Route: oral
Route: single
Dose: 800 mg
Sources:
unhealthy, 18 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 18 years
Sex: unknown
Population Size: 1
Sources:
Sleepy 1 patient
Disc. AE
600 mg single, oral
Overdose
Dose: 600 mg
Route: oral
Route: single
Dose: 600 mg
Sources:
unhealthy, 20 - 45 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 20 - 45 years
Sex: unknown
Population Size: 2
Sources:
Hypertension grade 3, 1 patient
Disc. AE
600 mg single, oral
Overdose
Dose: 600 mg
Route: oral
Route: single
Dose: 600 mg
Sources:
unhealthy, 20 - 45 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 20 - 45 years
Sex: unknown
Population Size: 2
Sources:
Sore throat 1 patient
Disc. AE
500 mg single, oral
Overdose
Dose: 500 mg
Route: oral
Route: single
Dose: 500 mg
Sources:
unhealthy, 28 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 28 years
Sex: unknown
Population Size: 1
Sources:
Ataxic 1 patient
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 29 - 46 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 29 - 46 years
Sex: unknown
Population Size: 2
Sources:
Sleepy 1 patient
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
unhealthy, 29 - 46 years
n = 2
Health Status: unhealthy
Condition: mental disorders
Age Group: 29 - 46 years
Sex: unknown
Population Size: 2
Sources:
GI pain 1 patient
Disc. AE
700 mg single, oral
Overdose
Dose: 700 mg
Route: oral
Route: single
Dose: 700 mg
Sources:
unhealthy, 36 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 36 years
Sex: unknown
Population Size: 1
Sources:
Sleepy 1 patient
Disc. AE
640 mg single, oral
Overdose
Dose: 640 mg
Route: oral
Route: single
Dose: 640 mg
Sources:
unhealthy, 50 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 50 years
Sex: unknown
Population Size: 1
Sources:
Nausea 1 patient
Disc. AE
1120 mg single, oral
Overdose
Dose: 1120 mg
Route: oral
Route: single
Dose: 1120 mg
Sources:
unhealthy, 51 years
n = 1
Health Status: unhealthy
Condition: mental disorders
Age Group: 51 years
Sex: unknown
Population Size: 1
Sources:
Decreased appetite below serious, 10 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Vomiting below serious, 4 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Tachycardia below serious, 5 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Nasopharyngitis below serious, 7 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Faecaloma serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Intentional overdose serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Suicidal ideation serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Suicide attempt serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 134
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adolescent
Population Size: 134
Sources:
Fatigue below serious, 1 patient
80 mg 1 times / day steady, oral (max)
Dose: 80 mg, 1 times / day
Route: oral
Route: steady
Dose: 80 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 25
Health Status: unhealthy
Condition: Body Dysmorphic Disorder
Age Group: adolescent
Population Size: 25
Sources:
Insomnia below serious, 1 patient
80 mg 1 times / day steady, oral (max)
Dose: 80 mg, 1 times / day
Route: oral
Route: steady
Dose: 80 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 25
Health Status: unhealthy
Condition: Body Dysmorphic Disorder
Age Group: adolescent
Population Size: 25
Sources:
Pain stomach below serious, 2 patients
80 mg 1 times / day steady, oral (max)
Dose: 80 mg, 1 times / day
Route: oral
Route: steady
Dose: 80 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 25
Health Status: unhealthy
Condition: Body Dysmorphic Disorder
Age Group: adolescent
Population Size: 25
Sources:
Suicidal behavior serious, 1 patient
80 mg 1 times / day steady, oral (max)
Dose: 80 mg, 1 times / day
Route: oral
Route: steady
Dose: 80 mg, 1 times / day
Sources:
unhealthy, adolescent
n = 25
Health Status: unhealthy
Condition: Body Dysmorphic Disorder
Age Group: adolescent
Population Size: 25
Sources:
Drowsiness 14 patients
Disc. AE
544 mg single, oral (mean)
Overdose
Dose: 544 mg
Route: oral
Route: single
Dose: 544 mg
Sources:
unhealthy, adult
n = 37
Health Status: unhealthy
Condition: mental disorders
Age Group: adult
Sex: unknown
Population Size: 37
Sources:
Tachycardia 15 patients
Disc. AE
544 mg single, oral (mean)
Overdose
Dose: 544 mg
Route: oral
Route: single
Dose: 544 mg
Sources:
unhealthy, adult
n = 37
Health Status: unhealthy
Condition: mental disorders
Age Group: adult
Sex: unknown
Population Size: 37
Sources:
Nausea 4 patients
Disc. AE
544 mg single, oral (mean)
Overdose
Dose: 544 mg
Route: oral
Route: single
Dose: 544 mg
Sources:
unhealthy, adult
n = 37
Health Status: unhealthy
Condition: mental disorders
Age Group: adult
Sex: unknown
Population Size: 37
Sources:
Vomited 4 patients
Disc. AE
544 mg single, oral (mean)
Overdose
Dose: 544 mg
Route: oral
Route: single
Dose: 544 mg
Sources:
unhealthy, adult
n = 37
Health Status: unhealthy
Condition: mental disorders
Age Group: adult
Sex: unknown
Population Size: 37
Sources:
Tremor 5 patients
Disc. AE
544 mg single, oral (mean)
Overdose
Dose: 544 mg
Route: oral
Route: single
Dose: 544 mg
Sources:
unhealthy, adult
n = 37
Health Status: unhealthy
Condition: mental disorders
Age Group: adult
Sex: unknown
Population Size: 37
Sources:
Abnormal dreams 1%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Libido decreased 1%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Vasodilatation 1%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Yawn 1%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Insomnia 10%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Nausea 12%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Rash 2%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Sweating 2%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Tremor 3%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Anorexia 5%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Dry mouth 5%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Somnolence 5%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Anxiety 6%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Dyspepsia 6%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Asthenia 7%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Nervousness 8%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Diarrhea 9%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
n = 425
Health Status: unhealthy
Condition: Panic Disorder
Age Group: adult
Sex: unknown
Population Size: 425
Sources:
Abnormal dreams 1%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Dry mouth 10%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Tremor 10%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Anorexia 11%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Anxiety 12%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Diarrhea 12%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Somnolence 13%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Nervousness 14%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Insomnia 16%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Nausea 21%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Libido decreased 3%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Vasodilatation 3%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Rash 4%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Dyspepsia 7%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Sweating 8%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Asthenia 9%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 1728
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: adult
Sex: unknown
Population Size: 1728
Sources:
Dyspepsia 10%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Libido decreased 11%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Dry mouth 12%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Anxiety 14%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Nervousness 14%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Asthenia 15%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Anorexia 17%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Somnolence 17%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Diarrhea 18%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Nausea 26%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Insomnia 28%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Abnormal dreams 5%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Vasodilatation 5%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Rash 6%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Sweating 7%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Yawn 7%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Tremor 9%
20 mg 1 times / day steady, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
n = 266
Health Status: unhealthy
Condition: OCD
Age Group: adult
Sex: unknown
Population Size: 266
Sources:
Nervousness 10%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Insomnia 12%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Somnolence 13%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Diarrhoea 15%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Rhinitis 17%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Asthenia 18%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Nausea 18%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Headache 22%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Pharyngitis 5%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Dizziness 6%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Tremor 6%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Anxiety 7%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Pain 7%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Flu syndrome 8%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Sweating 9%
60 mg 1 times / day steady, oral (median)
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 391
Health Status: unhealthy
Condition: obese diabetic
Age Group: adult
Sex: unknown
Population Size: 391
Sources:
Dyspepsia 10%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Nervousness 11%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Yawn 11%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Somnolence 13%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Tremor 13%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Anxiety 15%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Vasodilatation 2%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Asthenia 21%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Nausea 29%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Insomnia 33%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Rash 4%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Abnormal dreams 5%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Libido decreased 5%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Anorexia 8%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Diarrhea 8%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Sweating 8%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Dry mouth 9%
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
unhealthy, adult
n = 450
Health Status: unhealthy
Condition: Bulimia
Age Group: adult
Sex: unknown
Population Size: 450
Sources:
Hypomania 1.8%
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, children
n = 228
Health Status: unhealthy
Condition: mental disorders
Age Group: children
Sex: unknown
Population Size: 228
Sources:
Abdominal pain upper below serious, 4 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Upper respiratory tract infection below serious, 5 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Insomnia below serious, 6 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Depressive symptom serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Hallucination, auditory serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Overdose serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Suicidal ideation serious, 3 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescent
n = 97
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescent
Population Size: 97
Sources:
Nausea below serious, 13 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Influenza below serious, 2 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Fatigue below serious, 6 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Vomiting below serious, 7 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Abdominal pain upper below serious, 9 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Suicidal ideation serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Suicide attempt serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 112
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 112
Sources:
Decreased appetite below serious, 10 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Nausea below serious, 15 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Headache below serious, 18 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Upper respiratory tract infection below serious, 3 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Dizziness below serious, 4 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Incorrect dose administered below serious, 4 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Insomnia below serious, 6 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Vomiting below serious, 6 patients
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Gastritis serious, 1 patient
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Lymphadenitis serious, 1 patient
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Ulna fracture serious, 1 patient
40 mg 1 times / day steady, oral (max)
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, children|adolescents
n = 117
Health Status: unhealthy
Condition: Major Depressive Disorder
Age Group: children|adolescents
Population Size: 117
Sources:
Blood triglycerides increased below serious, 1 patient
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
healthy
n = 8
Health Status: healthy
Sex: M
Population Size: 8
Sources:
Aspartate aminotransferase increased below serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Diarrhoea below serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Stomatitis below serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Alanine aminotransferase increased below serious, 2 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Dizziness below serious, 5 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
n = 46
Health Status: unhealthy
Condition: Depression
Sex: F
Population Size: 46
Sources:
Headache below serious, 6 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
n = 46
Health Status: unhealthy
Condition: Depression
Sex: F
Population Size: 46
Sources:
Anxiety below serious, 8 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
n = 46
Health Status: unhealthy
Condition: Depression
Sex: F
Population Size: 46
Sources:
White blood cell count decreased below serious, 2 patients
40 mg single, oral
Dose: 40 mg
Route: oral
Route: single
Dose: 40 mg
Sources:
healthy
n = 8
Health Status: healthy
Sex: M
Population Size: 8
Sources:
Alanine aminotransferase increased below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Anxiety below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Aspartate aminotransferase increased below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Blood triglycerides increased below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Conjunctivitis allergic below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Dizziness below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Excoriation below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Haemorrhoids below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Proctalgia below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
White blood cell count decreased below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
White blood cell count increased below serious, 1 patient
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Atrioventricular block first degree below serious, 2 patients
40 mg 1 times / day steady, oral
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
healthy
n = 12
Health Status: healthy
Sex: M
Population Size: 12
Sources:
Suicide attempt serious, 1 patient
80 mg 1 times / day steady, oral (max)
Dose: 80 mg, 1 times / day
Route: oral
Route: steady
Dose: 80 mg, 1 times / day
Sources:
unhealthy
n = 49
Health Status: unhealthy
Condition: Anorexia Nervosa
Sex: F
Population Size: 49
Sources:
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
moderate [IC50 31 uM]
moderate
moderate
moderate
yes (co-administration study)
Comment: addition of fluoxetine 20 mg/day to pre-existing risperidone therapy produced a mean 4- fold increase in plasma risperidone concentration, with some patients exhibiting an increase as large as 10-fold
no
strong [IC50 1.05 uM]
yes (co-administration study)
Comment: Coadministration of fluoxetine with other drugs that are metabolized by CYP2D6, including certain antidepressants (e.g., TCAs), antipsychotics (e.g., phenothiazines and most atypicals), and antiarrhythmics (e.g., propafenone, flecainide, and others) should be approached with caution
yes [IC50 14 uM]
yes [IC50 16 uM]
yes [IC50 3.32 uM]
yes [IC50 30 uM]
yes [IC50 5 uM]
yes [IC50 6.2 uM]
yes
yes
yes (co-administration study)
Comment: Fluoxetine dosing inhibited CYP2C19 activity in both age groups, increasing the (S)- to (R)-mephenytoin ratio 3- to 4-fold
Drug as victimTox targets
Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
Fluoxetine-resistant mutants in C. elegans define a novel family of transmembrane proteins.
1999 Aug
A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder.
1999 Jul
Fluoxetine inhibits the metabolism of tolterodine-pharmacokinetic implications and proposed clinical relevance.
1999 Oct
Side effects as predictors of drug response in obsessive-compulsive disorder.
1999 Oct
The promotion effect of anorectic drugs on aflatoxin B(1)-induced hepatic preneoplastic foci.
1999 Sep
[Fluoxetine (FX) efficacy in the treatment of cocaine dependence methadone maintenance patients. Interaction with plasma levels].
1999 Sep-Oct
Methadone, ciprofloxacin, and adverse drug reactions.
2000 Dec 16
Antidepressant drugs appear to enhance cocaine-induced toxicity.
2000 Feb
Female sexual dysfunction associated with antidepressant administration: a randomized, placebo-controlled study of pharmacologic intervention.
2000 Feb
Fluoxetine-induced anaesthesia of vagina and nipples.
2000 Mar
[SIADH with epileptic seizures and coma in fluoxetine therapy].
2000 Mar 2
Fluoxetine toxicity in a preterm infant.
2000 Oct-Nov
Fluoxetine-related death in a child with cytochrome P-450 2D6 genetic deficiency.
2000 Spring
Fluoxetine: a review of its therapeutic potential in the treatment of depression associated with physical illness.
2001
Differential effects of fluvoxamine and other antidepressants on the biotransformation of melatonin.
2001 Apr
Characterization of 5-HT receptors in the parasitic nematode, Ascaris suum.
2001 Feb
Severe symptomatic hyponatremia during citalopram therapy.
2001 Feb
Influence of coadministration of fluoxetine on cisapride pharmacokinetics and QTc intervals in healthy volunteers.
2001 Feb
Reversible galactorrhea and prolactin elevation related to fluoxetine use.
2001 Feb
Long-term treatment of obsessive-compulsive disorder after an acute response: a comparison of fluoxetine versus placebo.
2001 Feb
Augmentation of fluoxetine's antidepressant action by pindolol: analysis of clinical, pharmacokinetic, and methodologic factors.
2001 Feb
Citalopram-induced bruxism.
2001 Feb
Female sexual dysfunction and antidepressant use.
2001 Feb
Effect of fluoxetine on carvedilol pharmacokinetics, CYP2D6 activity, and autonomic balance in heart failure patients.
2001 Jan
Fluoxetine-induced Ca2+ signals in Madin-Darby canine kidney cells.
2001 Jan
Effects of serotonin and fluoxetine on blood glucose regulation in two decapod species.
2001 Jan
Acute effect of different antidepressants on glycemia in diabetic and non-diabetic rats.
2001 Jan
A novel augmentation strategy for treating resistant major depression.
2001 Jan
Depression among pregnant adolescents: an integrated treatment approach.
2001 Jan
Repeated electroconvulsive stimulation, but not antidepressant drugs, induces mossy fibre sprouting in the rat hippocampus.
2001 Mar 2
Patents

Sample Use Guides

Usual Adult Dose for Bulimia Immediate-release oral formulations: Recommended dose: 60 mg orally once a day Usual Adult Dose for Depression Immediate-release oral formulations: Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed Maintenance dose: 20 to 60 mg orally per day Maximum dose: 80 mg orally per day Delayed release oral capsules: Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations. Usual Adult Dose for Obsessive Compulsive Disorder Immediate-release oral formulations: Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed. Maintenance dose: 20 to 60 mg orally per day Maximum dose: 80 mg orally per day Usual Adult Dose for Panic Disorder Immediate-release oral formulations: Initial dose: 10 mg orally once a day, increased after one week to 20 mg orally once a day Maintenance dose: 20 to 60 mg orally per day Maximum dose: 60 mg orally per day
Route of Administration: Oral
Caco-2 SERT was also shown to be a high affinity (Kt=0.216 uM) saturable, Na(+) -dependent transporter that was inhibited by fluoxetine (IC(50)=17.6 nM).
Substance Class Chemical
Created
by admin
on Fri Jun 25 22:11:01 UTC 2021
Edited
by admin
on Fri Jun 25 22:11:01 UTC 2021
Record UNII
01K63SUP8D
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
FLUOXETINE
INN   MI   USAN   VANDF   WHO-DD  
INN   USAN  
Official Name English
FLUOXETINE [INN]
Common Name English
(+/-)-N-METHYL-3-PHENYL-3-((.ALPHA.,ALPHA.,.ALPHA.-TRIFLUORO-P-TOLYL)OXY)PROPYLAMINE
Common Name English
FLUOXETIN RATIOPHARM
Common Name English
DL-N-METHYL-3-(P-TRIFLUOROMETHYLPHENOXY)-3-PHENYLPROPYLAMINE
Common Name English
FLUOXETINE [USAN]
Common Name English
NSC-283480
Code English
NSC-758685
Code English
FLUOXETINE [EMA EPAR VETERINARY]
Common Name English
FLUOXETINE [WHO-DD]
Common Name English
FLUOXETINE [VANDF]
Common Name English
N-METHYL-.GAMMA.-(4-(TRIFLUOROMETHYL)PHENOXY)BENZENEPROPANAMINE
Systematic Name English
FLUOXETINE [MI]
Common Name English
FLUVAL
Common Name English
BENZENEPROPANAMINE, N-METHYL-G-(4-(TRIFLUOROMETHYL)PHENOXY)-, (+/-)-
Common Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 183504
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
NDF-RT N0000000109
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
WHO-ATC N06AB03
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
EMA VETERINARY ASSESSMENT REPORTS RECONCILE [AUTHORIZED]
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
FDA ORPHAN DRUG 123199
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
LIVERTOX 424
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
WHO-ATC N06CA03
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
WHO-VATC QN06AB03
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
WHO-ESSENTIAL MEDICINES LIST 24.2.1
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
WHO-ESSENTIAL MEDICINES LIST 8.4
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
NCI_THESAURUS C94725
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
CFR 21 CFR 520.980
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
NCI_THESAURUS C265
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
NDF-RT N0000175696
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
WHO-VATC QN06CA03
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
Code System Code Type Description
WIKIPEDIA
FLUOXETINE
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
MERCK INDEX
M5487
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY Merck Index
CAS
54910-89-3
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
ChEMBL
CHEMBL41
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
EVMPD
SUB07723MIG
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
FDA UNII
01K63SUP8D
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
DRUG CENTRAL
1209
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
RXCUI
4493
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY RxNorm
NCI_THESAURUS
C506
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
EPA CompTox
54910-89-3
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
IUPHAR
203
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
PUBCHEM
3386
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
INN
3883
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
DRUG BANK
DB00472
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
MESH
D005473
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
LACTMED
Fluoxetine
Created by admin on Fri Jun 25 22:11:01 UTC 2021 , Edited by admin on Fri Jun 25 22:11:01 UTC 2021
PRIMARY
Related Record Type Details
METABOLIC ENZYME -> SUBSTRATE
METABOLIC ENZYME -> INHIBITOR
TARGET -> INHIBITOR
METABOLIC ENZYME -> INHIBITOR
SALT/SOLVATE -> PARENT
METABOLIC ENZYME -> SUBSTRATE
SALT/SOLVATE -> PARENT
Related Record Type Details
METABOLITE -> PARENT
METABOLITE ACTIVE -> PARENT
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
MAXIMUM TOLERATED DOSE TOXICITY RAPID METABOLIZERS OR THOSE WITH INADEQUATE RESPONSE AFTER 8 WEEKS

Tmax PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC NORFLUOXETINE
PHARMACOKINETIC
NORFLUOXETINE, LIVER CIRRHOSIS
PHARMACOKINETIC
LIVER CIRRHOSIS
PHARMACOKINETIC