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Details

Stereochemistry RACEMIC
Molecular Formula C14H11ClN2O4S
Molecular Weight 338.7677
Optical Activity ( + / - )
Defined Stereocenters 0 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of CHLORTHALIDONE

SMILES

c1ccc2c(c1)C(=NC2(c3ccc(c(c3)S(=O)(=O)N)Cl)O)O

InChI

InChIKey=JIVPVXMEBJLZRO-UHFFFAOYSA-N
InChI=1S/C14H11ClN2O4S/c15-11-6-5-8(7-12(11)22(16,20)21)14(19)10-4-2-1-3-9(10)13(18)17-14/h1-7,19H,(H,17,18)(H2,16,20,21)

HIDE SMILES / InChI

Molecular Formula C14H11ClN2O4S
Molecular Weight 338.7677
Charge 0
Count
Stereochemistry RACEMIC
Additional Stereochemistry No
Defined Stereocenters 0 / 1
E/Z Centers 0
Optical Activity ( + / - )

Chlorthalidone is a diuretic that is used for the treatment of hypertansion and edema. The drug is approved by FDA and either prescribed alone (Chlorthalidone trade name) or in combination with atenolol (Tenoretic trade name), azilsartan kamedoxomil (Edarbyclor) and clonidin (Clorpres). The mechanism of action is associated with activation of sodium and chloride renal excretion.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Palliative
CHLORTHALIDONE

Approved Use

Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Launch Date

3.51907185E11
Palliative
CHLORTHALIDONE

Approved Use

Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Launch Date

3.51907185E11
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
1529 μg/mL
25 mg single, oral
dose: 25 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CHLORTHALIDONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
93.3 μg × h/mL
25 mg single, oral
dose: 25 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CHLORTHALIDONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
54 h
25 mg single, oral
dose: 25 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CHLORTHALIDONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
50 h
CHLORTHALIDONE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
25%
CHLORTHALIDONE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
400 mg 1 times / day multiple, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: multiple
Dose: 400 mg, 1 times / day
Sources:
unhealthy, mean age 47 years
n = 10
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 47 years
Sex: M+F
Population Size: 10
Sources:
Other AEs: Hypokalemia...
Other AEs:
Hypokalemia
Sources:
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Other AEs: Dry mouth, Energy decreased...
Other AEs:
Dry mouth
Energy decreased
Muscle cramps
Nausea
Dizziness postural
Indigestion
Dreaming excessive
Constipation
Nervousness
Headaches
Gas
Tiredness
Trouble falling asleep
Urination frequency of
Decreased appetite
Sources:
75 mg 1 times / day multiple, oral
Studied dose
Dose: 75 mg, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg, 1 times / day
Sources:
unhealthy, mean age 55.3 years
n = 19
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 55.3 years
Sex: M+F
Population Size: 19
Sources:
Other AEs: Headaches, Dizziness...
Other AEs:
Headaches (5.3%)
Dizziness (15.8%)
Cramps (5.3%)
Orthostatic hypotension (10.5%)
Dry mouth (5.3%)
Sources:
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Other AEs: Blood creatinine increased, Dizziness...
Other AEs:
Blood creatinine increased (18.6%)
Dizziness (13.5%)
Headache (5.8%)
Hypokalemia (3.2%)
Blood creatine phosphokinase increased (6.4%)
Blood uric acid increased (4.5%)
Blood urea increased (5.1%)
Diarrhea (3.2%)
Fatigue (3.8%)
Nasopharyngitis (4.5%)
Upper respiratory infection (4.5%)
Hyperuricemia (1.9%)
Blood potassium decreased (1.9%)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Disc. AE: Blood creatinine increased, Dizziness...
AEs leading to
discontinuation/dose reduction:
Blood creatinine increased (6.4%)
Dizziness (3.8%)
Hypotension (0.6%)
Blood urea increased (0.6%)
Headache (0.6%)
Fatigue (0.6%)
Diarrhea (0.6%)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 160
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 160
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
Disc. AE: Blood creatinine increased, Blood urea increased...
AEs leading to
discontinuation/dose reduction:
Blood creatinine increased (0.6%)
Blood urea increased (0.6%)
Headache (0.6%)
Hypokalemia (1.3%)
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Other AEs: Dizziness, Headache...
Other AEs:
Dizziness (3.3%)
Headache (7.2%)
Plasminogen activator inhibitor increased (1.7%)
Hypokalemia (6.1%)
Dyslipidemia (2.2%)
Asthenia (1.1%)
Urinary tract infection (1.7%)
Back pain (1.1%)
Fatigue (2.8%)
Blood uric acid increased (1.1%)
Muscle spasms (0.6%)
Peripheral edema (2.2%)
Upper respiratory tract infection (1.1%)
Blood creatine phosphokinase increased (1.7%)
Palpitations (2.2%)
Hematuria (0.6%)
Hypertriglyceridemia (1.1%)
Blood potassium decreased (1.7%)
Edema (0.6%)
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Other AEs: Dizziness, Headache...
Other AEs:
Dizziness (8.7%)
Headache (4.3%)
Plasminogen activator inhibitor increased (6.5%)
Hypokalemia (1.1%)
Dyslipidemia (3.8%)
Asthenia (3.3%)
Urinary tract infection (1.6%)
Back pain (3.8%)
Fatigue (3.3%)
Blood uric acid increased (2.2%)
Muscle spasms (2.7%)
Peripheral edema (2.2%)
Upper respiratory tract infection (2.2%)
Blood creatine phosphokinase increased (0.5%)
Palpitations (1.6%)
Hematuria (1.6%)
Hypertriglyceridemia (0.5%)
Blood creatinine increased (2.7%)
Diarrhea (2.2%)
C-reactive protein increased (2.2%)
Hypotension (2.2%)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
600 mg 1 times / day single, oral
Highest studied dose
Dose: 600 mg, 1 times / day
Route: oral
Route: single
Dose: 600 mg, 1 times / day
Sources:
healthy
n = 1
25 mg 1 times / day steady, oral
Dose: 25 mg, 1 times / day
Route: oral
Route: steady
Dose: 25 mg, 1 times / day
Sources:
unhealthy
n = 13
Health Status: unhealthy
Condition: Hypertension
Population Size: 13
Sources:
Other AEs: Hypokalemia, Hyponatremia...
Other AEs:
Hypokalemia (below serious, 1 patient)
Hyponatremia (below serious, 1 patient)
Sources:
AEs

AEs

AESignificanceDosePopulation
Hypokalemia
400 mg 1 times / day multiple, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: multiple
Dose: 400 mg, 1 times / day
Sources:
unhealthy, mean age 47 years
n = 10
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 47 years
Sex: M+F
Population Size: 10
Sources:
Constipation
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Decreased appetite
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Dizziness postural
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Dreaming excessive
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Dry mouth
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Energy decreased
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Gas
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Headaches
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Indigestion
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Muscle cramps
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Nausea
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Nervousness
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Tiredness
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Trouble falling asleep
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Urination frequency of
200 mg 1 times / day multiple, oral
Studied dose
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
unhealthy, mean age 53.6 years
n = 37
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 53.6 years
Sex: M+F
Population Size: 37
Sources:
Orthostatic hypotension 10.5%
75 mg 1 times / day multiple, oral
Studied dose
Dose: 75 mg, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg, 1 times / day
Sources:
unhealthy, mean age 55.3 years
n = 19
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 55.3 years
Sex: M+F
Population Size: 19
Sources:
Dizziness 15.8%
75 mg 1 times / day multiple, oral
Studied dose
Dose: 75 mg, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg, 1 times / day
Sources:
unhealthy, mean age 55.3 years
n = 19
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 55.3 years
Sex: M+F
Population Size: 19
Sources:
Cramps 5.3%
75 mg 1 times / day multiple, oral
Studied dose
Dose: 75 mg, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg, 1 times / day
Sources:
unhealthy, mean age 55.3 years
n = 19
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 55.3 years
Sex: M+F
Population Size: 19
Sources:
Dry mouth 5.3%
75 mg 1 times / day multiple, oral
Studied dose
Dose: 75 mg, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg, 1 times / day
Sources:
unhealthy, mean age 55.3 years
n = 19
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 55.3 years
Sex: M+F
Population Size: 19
Sources:
Headaches 5.3%
75 mg 1 times / day multiple, oral
Studied dose
Dose: 75 mg, 1 times / day
Route: oral
Route: multiple
Dose: 75 mg, 1 times / day
Sources:
unhealthy, mean age 55.3 years
n = 19
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 55.3 years
Sex: M+F
Population Size: 19
Sources:
Blood potassium decreased 1.9%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Hyperuricemia 1.9%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Dizziness 13.5%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Blood creatinine increased 18.6%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Diarrhea 3.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Hypokalemia 3.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Fatigue 3.8%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Blood uric acid increased 4.5%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Nasopharyngitis 4.5%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Upper respiratory infection 4.5%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Blood urea increased 5.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Headache 5.8%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Blood creatine phosphokinase increased 6.4%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Blood urea increased 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Diarrhea 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Fatigue 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Headache 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Hypotension 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Dizziness 3.8%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Blood creatinine increased 6.4%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 156
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 156
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99
Blood creatinine increased 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 160
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 160
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
Blood urea increased 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 160
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 160
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
Headache 0.6%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 160
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 160
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
Hypokalemia 1.3%
Disc. AE
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
unhealthy, mean age 57.2 years
n = 160
Health Status: unhealthy
Condition: hypertension
Age Group: mean age 57.2 years
Sex: M+F
Population Size: 160
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99
Edema 0.6%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Hematuria 0.6%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Muscle spasms 0.6%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Asthenia 1.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Back pain 1.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Blood uric acid increased 1.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Hypertriglyceridemia 1.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Upper respiratory tract infection 1.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Blood creatine phosphokinase increased 1.7%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Blood potassium decreased 1.7%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Plasminogen activator inhibitor increased 1.7%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Urinary tract infection 1.7%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Dyslipidemia 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Palpitations 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Peripheral edema 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Fatigue 2.8%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Dizziness 3.3%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Hypokalemia 6.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Headache 7.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 181
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 181
Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95
Blood creatine phosphokinase increased 0.5%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Hypertriglyceridemia 0.5%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Hypokalemia 1.1%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Hematuria 1.6%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Palpitations 1.6%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Urinary tract infection 1.6%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Blood uric acid increased 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
C-reactive protein increased 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Diarrhea 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Hypotension 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Peripheral edema 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Upper respiratory tract infection 2.2%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Blood creatinine increased 2.7%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Muscle spasms 2.7%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Asthenia 3.3%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Fatigue 3.3%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Back pain 3.8%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Dyslipidemia 3.8%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Headache 4.3%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Plasminogen activator inhibitor increased 6.5%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Dizziness 8.7%
25 mg 1 times / day multiple, oral
Recommended
Dose: 25 mg, 1 times / day
Route: oral
Route: multiple
Dose: 25 mg, 1 times / day
Co-administed with::
azilsartan medoxomil(40 mg; 1/day)
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
unhealthy, mean age >59 years
n = 184
Health Status: unhealthy
Condition: hypertension
Age Group: mean age >59 years
Sex: M+F
Population Size: 184
Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95
Hypokalemia below serious, 1 patient
25 mg 1 times / day steady, oral
Dose: 25 mg, 1 times / day
Route: oral
Route: steady
Dose: 25 mg, 1 times / day
Sources:
unhealthy
n = 13
Health Status: unhealthy
Condition: Hypertension
Population Size: 13
Sources:
Hyponatremia below serious, 1 patient
25 mg 1 times / day steady, oral
Dose: 25 mg, 1 times / day
Route: oral
Route: steady
Dose: 25 mg, 1 times / day
Sources:
unhealthy
n = 13
Health Status: unhealthy
Condition: Hypertension
Population Size: 13
Sources:
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG

OverviewOther

Other InhibitorOther SubstrateOther Inducer
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
PubMed

PubMed

TitleDatePubMed
[Severe perioperative hypotension after nephrectomy with adrenalectomy].
2002 Apr
[Diabetes and drug treatment of hypertension].
2003
Lacidipine: a review of its use in the management of hypertension.
2003
[Results of clinical evidence: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)].
2003
[Primary prevention of stroke. What helps--what does not help? The guidelines of the German Society of Neurology briefly summarized].
2003
Renal hypomagnesemia, hypercalciuria and nephrocalcinosis in a middle-aged man.
2003
Diuretics: older, cheaper, better.
2003 Apr
[Treating hypertension is more important than the choice of agent; results from the largest clinical trial until now].
2003 Apr 12
Long-term cardiovascular consequences of diuretics vs calcium channel blockers vs angiotensin-converting enzyme inhibitors.
2003 Apr 23-30
Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitors or calcium channel blocker vs diuretic. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
2003 Aug
ALLHAT--all hit or all miss? Key questions still remain.
2003 Aug 1
[Recent intervention studies with antihypertensive drugs and their influence on guidelines].
2003 Dec 15
Back to thiazide-diuretics for hypertension: reflections after a decade of irrational prescribing.
2003 Dec 23
[The ALLHAT study: contributions, limitations and prospectives].
2003 Feb
Diuretics: first choice for treating high BP.
2003 Feb
[Clinical study of the month. Which initial antihypertensive? Results from the ALLHAT trial].
2003 Jan
Results of the ALLHAT trial: is the debate about initial antihypertensive drug therapy over?
2003 Jan-Feb
Are thiazide diuretics preferred as first-line therapy for hypertension? An appraisal of The Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
2003 Jul
Angiotensin-converting-enzyme inhibitors and diuretics for hypertension.
2003 Jul 3
Amlodipine or lisinopril was not better than chlorthalidone in lowering CHD risk in hypertension.
2003 Jul-Aug
A cheaper way to control high blood pressure.
2003 Mar
High praise for an old standby. Low-cost diuretics excel in combating high blood pressure.
2003 Mar
The ALLHAT Trial. Diuretics are still the preferred initial drugs for high blood pressure.
2003 Mar
Hats off to an old blood pressure drug. For treating high blood pressure, an old--and inexpensive--medication is a great place to start or a good one to add.
2003 Mar
Benign intracranial hypertension in association with acute lymphoblastic leukemia.
2003 Mar
[What are the sequelae of the ALLHAT Study?].
2003 Mar 28
[ALLHAT: Old Hat Hits All? On selection of the optimal antihypertensive drug].
2003 Mar 31
Diuretics: drugs of choice for the initial management of patients with hypertension.
2003 May
Antihypertensive therapy with verapamil SR plus trandolapril versus atenolol plus chlorthalidone on glycemic control.
2003 May
ACE inhibitors versus diuretics: ALLHAT versus ANBP2.
2003 May
Recommendations for the management of special populations: racial and ethnic populations.
2003 Nov
ALLHAT, or the soft science of the secondary end point.
2003 Nov 4
Characteristics and lipid distribution of a large, high-risk, hypertensive population: the lipid-lowering component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
2003 Nov-Dec
What ALLHAT tells us about treating high-risk patients with hypertension and hyperlipidemia.
2003 Nov-Dec
Calcium antagonists and atherosclerosis protection in hypertension.
2003 Nov-Dec
Amlodipine or lisinopril was not better than chlorthalidone in lowering CHD risk in hypertension.
2003 Nov-Dec
Diuretic versus alpha-blocker as first-step antihypertensive therapy: final results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
2003 Sep
[For every hypertensive patient a diuretic first? "Not advisable in diabetic patients"].
2003 Sep 11
The potential savings of using thiazides as the first choice antihypertensive drug: cost-minimisation analysis.
2003 Sep 8
Effect of antihypertensive agents on quality of life in the elderly.
2004
A family physician questions the conclusions from ALLHAT.
2004 Apr
Foot volume increase on nifedipine is not prevented by pretreatment with diuretics.
2004 Feb
Hypothetical economic analysis of screening for left ventricular hypertrophy in high-risk normotensive populations.
2004 Feb
Guidelines for antihypertensive treatment: an update after the ALLHAT study.
2004 Jan
Relationship between blood glucose control, pathogenesis and progression of diabetic nephropathy.
2004 Jan
Hydrochlorothiazide versus chlorthalidone: evidence supporting their interchangeability.
2004 Jan
Effects of pH and the presence of micelles on the resolution of diuretics by reversed-phase liquid chromatography.
2004 Jan 2
[Can hydrochlorothiazide and chlorthalidone be compared in the treatment of hypertension?].
2004 Mar 18
Blockade of the angiotensin II type 1 receptor stabilizes atherosclerotic plaques in humans by inhibiting prostaglandin E2-dependent matrix metalloproteinase activity.
2004 Mar 30
The 45-year story of the development of an anti-aldosterone more specific than spironolactone.
2004 Mar 31
Patents

Sample Use Guides

Hypertension: starting dose is 25 mg once daily. Edema: 100 mg daily, or 100 mg on alternate days.
Route of Administration: Oral
The binding of chlorthalidone to human blood components has been studied in vitro. When the concentration of chlorthalidone in blood was less than 15–20 ug/ml, more than 98% of the compound was bound to red cells. In human serum at 37C, over a concentration range of 0.02–7.7 ug/ml, 75.7% of chlorthalidone was bound to proteins. The association constant with carbonic anhydrase was 2.76×10(6) l/mole.
Substance Class Chemical
Created
by admin
on Fri Jun 25 20:50:59 UTC 2021
Edited
by admin
on Fri Jun 25 20:50:59 UTC 2021
Record UNII
Q0MQD1073Q
Record Status Validated (UNII)
Record Version
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Name Type Language
CHLORTHALIDONE
HSDB   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF  
USAN  
Official Name English
HYGROTON
Brand Name English
CLORPRES COMPONENT CHLORTHALIDONE
Common Name English
G-33182
Code English
CHLORTALIDONE [JAN]
Common Name English
CHLORTHALIDONE COMPONENT OF KERLEDEX
Common Name English
COMBIPRES COMPONENT CHLORTHALIDONE
Common Name English
CHLORTHALIDONE COMPONENT OF TENORETIC
Common Name English
BENZENESULFONAMIDE, 2-CHLORO-5-(2,3-DIHYDRO-1-HYDROXY-3-OXO-1H-ISOINDOL-1-YL)-
Systematic Name English
CHLORTHALIDONE COMPONENT OF COMBIPRES
Common Name English
CHLORTALIDONUM [WHO-IP LATIN]
Common Name English
CHLORTALIDONE [INN]
Common Name English
CHLORTHALIDONE COMPONENT OF REGROTON
Common Name English
REGROTON COMPONENT CHLORTHALIDONE
Common Name English
LOPRESSIDONE COMPONENT CHLORTHALIDONE
Common Name English
CHLORTHALIDONE COMPONENT OF CLORPRES
Common Name English
CHLORTALIDONE [WHO-IP]
Common Name English
CHLORTALIDONE [EP MONOGRAPH]
Common Name English
CHLORTHALIDONE [USAN]
Common Name English
CHLORTALIDONE [EP]
Common Name English
CHLORTHALIDONE [USP MONOGRAPH]
Common Name English
CHLORTALIDONE [MART.]
Common Name English
DEMI-REGROTON COMPONENT CHLORTHALIDONE
Common Name English
CHLORTHALIDONE COMPONENT OF DEMI-REGROTON
Common Name English
CHLORTHALIDONE COMPONENT OF LOPRESSIDONE
Common Name English
TENORETIC COMPONENT CHLORTHALIDONE
Common Name English
PHTHALAMUDINE
Common Name English
CHLORTHALIDONE [VANDF]
Common Name English
CHLORTHALIDONE [MI]
Common Name English
CHLORTALIDONE [WHO-DD]
Common Name English
CHLORTALIDONE
EP   INN   JAN   MART.   WHO-DD   WHO-IP  
INN  
Official Name English
CHLORTHALIDONE [USP-RS]
Common Name English
KERLEDEX COMPONENT CHLORTHALIDONE
Common Name English
NSC-69200
Code English
CHLORTHALIDONE [HSDB]
Common Name English
CHLORTHALIDONE [ORANGE BOOK]
Common Name English
NATRIURAN
Common Name English
THALITONE
Brand Name English
2-CHLORO-5-(1-HYDROXY-3-OXO-1-ISOINDOLINYL)BENZENESULFONAMIDE
Systematic Name English
Classification Tree Code System Code
WHO-VATC QC03BA04
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
NCI_THESAURUS C49185
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
NDF-RT N0000175420
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
WHO-ATC C03EA06
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
NDF-RT N0000175359
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
WHO-ATC C03BA04
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
WHO-VATC QC03EA06
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
LIVERTOX 199
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
WHO-ATC C03BB04
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
WHO-VATC QC03BB04
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
Code System Code Type Description
USP_CATALOG
1130006
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY USP-RS
RXCUI
2409
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY RxNorm
MERCK INDEX
M3470
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY Merck Index
INN
1125
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
HSDB
3035
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
DRUG CENTRAL
625
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
CHLORTHALIDONE
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY Description: A white to yellowish white, crystalline powder; odourless or almost odourless.Solubility: Practically insoluble in water and ether R; soluble in methanol R; slightly soluble in ethanol (~750 g/l) TS.Category: Diuretic.Storage: Chlortalidone should be kept in a well-closed container.
EPA CompTox
77-36-1
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
DRUG BANK
DB00310
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
EVMPD
SUB06212MIG
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
LACTMED
Chlorthalidone
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
CAS
77-36-1
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
WIKIPEDIA
CHLORTALIDONE
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
NCI_THESAURUS
C47449
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
MESH
D002752
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
FDA UNII
Q0MQD1073Q
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
ChEMBL
CHEMBL1055
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
PUBCHEM
2732
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
ECHA (EC/EINECS)
201-022-5
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
IUPHAR
7147
Created by admin on Fri Jun 25 20:50:59 UTC 2021 , Edited by admin on Fri Jun 25 20:50:59 UTC 2021
PRIMARY
Related Record Type Details
BINDER->LIGAND
BINDING
ENANTIOMER -> RACEMATE
ENANTIOMER -> RACEMATE
Related Record Type Details
IMPURITY -> PARENT
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC