PREGABALIN SODIUM

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C8H16NO2.Na
Molecular Weight	181.2079
Optical Activity	( + )
Defined Stereocenters	1 / 1
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

[Na+].CC(C)C[C@H](CN)CC([O-])=O

InChI

InChIKey=RDOYGLCZFATQEB-FJXQXJEOSA-M

InChI=1S/C8H17NO2.Na/c1-6(2)3-7(5-9)4-8(10)11;/h6-7H,3-5,9H2,1-2H3,(H,10,11);/q;+1/p-1/t7-;/m0./s1

HIDE SMILES / InChI

Molecular Formula	Na
Molecular Weight	22.9898
Charge	1
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Molecular Formula	C8H16NO2
Molecular Weight	158.2181
Charge	-1
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	1 / 1
E/Z Centers	0
Optical Activity	UNSPECIFIED

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf
Curator's Comment: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/17126531

Pregabalin, marketed under the brand name Lyrica among others. LYRICA is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) Postherpetic neuralgia (PHN); Adjunctive therapy for adult patients with partial onset seizures; Fibromyalgia; Neuropathic pain associated with spinal cord injury. It has been shown the clinical effects of pregabalin are likely due to direct and selective interactions with α(2)δ-1 and α(2)δ-2 subunits of voltage-gated calcium channels. While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid (GABA), it does not bind directly to GABAA, GABAB, or benzodiazepine receptors, does not augment GABAA responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation. However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Voltage-gated calcium channel alpha2/delta subunit 2 6 Target ID: CHEMBL3896 Sources: https://www.ncbi.nlm.nih.gov/pubmed/?term=21651903	Binding Agent 1064
Voltage-gated calcium channel alpha2/delta subunit 1 19 Target ID: CHEMBL1919 Sources: https://www.ncbi.nlm.nih.gov/pubmed/?term=21651903	Binding Agent 1064

Conditions

Condition	Modality	Highest Phase	Product
Diabetic peripheral neuropathy 8 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf	Palliative	Approved 8429	LYRICA Approved Use LYRICA is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for adult patients with partial onset seizures Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for adult patients with partial onset seizures (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1) Launch Date 2004
Postherpetic neuralgia 13 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf	Palliative	Approved 8429	LYRICA Approved Use LYRICA is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for adult patients with partial onset seizures Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for adult patients with partial onset seizures (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1) Launch Date 2004
Partial onset seizures 5 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf	Palliative	Approved 8429	LYRICA Approved Use LYRICA is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for adult patients with partial onset seizures Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for adult patients with partial onset seizures (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1) Launch Date 2004
Fibromyalgia 89 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf	Palliative	Approved 8429	LYRICA Approved Use LYRICA is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for adult patients with partial onset seizures Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for adult patients with partial onset seizures (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1) Launch Date 2004

C_max

Value	Dose	Co-administered	Analyte	Population
4568.68 ng/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/28513426	150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered:		PREGABALIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

AUC

Value	Dose	Co-administered	Analyte	Population
29831.454 ng × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/28513426	150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered:		PREGABALIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

T_1/2

Value	Dose	Co-administered	Analyte	Population
6.3 h DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf	unknown, oral		PREGABALIN plasma	Homo sapiens population: UNKNOWN age: ADULT sex: UNKNOWN food status: UNKNOWN

Doses

Dose	Population	Adverse events
600 mg single, oral Highest studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: https://pubmed.ncbi.nlm.nih.gov/30349198	healthy, 24.8 years n = 10 Health Status: healthy Age Group: 24.8 years Sex: M Population Size: 10 Sources: https://pubmed.ncbi.nlm.nih.gov/30349198	Other AEs: Vision blurred, Nausea... Other AEs: Vision blurred (moderate, 1 patient) Nausea (moderate, 1 patient) Dizziness (mild, 4 patients) Dysarthria (moderate, 1 patient) Headache (mild, 2 patients) Sources: https://pubmed.ncbi.nlm.nih.gov/30349198
600 mg 1 times / day multiple, oral Highest studied dose Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/17580330	unhealthy, 53.91 years n = 22 Health Status: unhealthy Condition: Essential Tremor Age Group: 53.91 years Sex: M+F Population Size: 22 Sources: https://pubmed.ncbi.nlm.nih.gov/17580330	Sources: https://pubmed.ncbi.nlm.nih.gov/17580330
150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	Disc. AE: Dizziness, Somnolence... AEs leading to discontinuation/dose reduction: Dizziness (3.47%) Somnolence (2.76%) Asthenia (0.82%) Confusion (0.72%) Peripheral edema (0.61%) Headache (1.12%) Amblyopia (0.82%) Dry mouth (0.72%) Nausea (0.72%) Infection (0.41%) Ataxia (0.41%) Neuropathy (0.41%) Tremor (0.41%) Constipation (0.31%) Diarrhea (0.31%) Incoordination (0.31%) Abnormal thinking (0.31%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF

AEs

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inhibitor 1587 inducer 781	inhibitor 1767	inhibitor 1852	inhibitor 1612

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
CYP1A2 1524 CYP2A6 707 CYP2C19 1478 CYP2E1 882	P-gp 1537 OCT2 355 OCTN1 47 OAT1 326 OAT3 339 OCTN2 50	CYP1A2 701

Drug as perpetrator

Target	Modality	Activity
CYP1A2 1692	inducer 1573 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf#page=34 Page: 34.0	no
CYP1A2 1692	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=5 Page: 5.0	no
CYP2A6 739	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=5 Page: 5.0	no
CYP2C19 1553	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=5 Page: 5.0	no
CYP2C9 1819	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=5 Page: 5.0	no
CYP2D6 1891	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=5 Page: 5.0	no
CYP2E1 970	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=5 Page: 5.0	no
CYP3A4 1925	inducer 1573 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf#page=34 Page: 34.0	no
CYP3A4 1925	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=5 Page: 5.0	no

Drug as victim

Target	Modality	Activity
OAT1 326	substrate 3367 Sources: https://www.iqpc.com/media/8156/15859.pdf#page=6 Page: 6.0	no
OAT3 339	substrate 3367 Sources: https://www.iqpc.com/media/8156/15859.pdf#page=6 Page: 6.0	no
OCTN2 50	substrate 3367 Sources: https://www.iqpc.com/media/8156/15859.pdf#page=6 Page: 6.0	no
P-gp 1537	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_biopharmr.PDF#page=25 Page: 25.0	no
OCT2 355	substrate 3367 Sources: https://www.iqpc.com/media/8156/15859.pdf#page=5 Page: 5.0	yes
OCTN1 47	substrate 3367 Sources: https://www.iqpc.com/media/8156/15859.pdf#page=5 Page: 5.0	yes

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 1647	inhibitor 1626 Sources: https://www.ema.europa.eu/en/documents/scientific-discussion-variation/lyrica-h-c-546-ii-0004-epar-scientific-discussion-variation_en.pdf#page=2 Page: 2.0

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:64356	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:64356
ChemicalBook	CB2251105	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB2251105
ZINC	ZINC000000005152	http://zinc15.docking.org/substances/ZINC000000005152
eMolecules	8324194	https://www.emolecules.com/cgi-bin/more?vid=8324194

PubMed

Title	Date	PubMed
Future prospects for the drug treatment of epilepsy.	2001	11735615
Benzodiazepines and anticonvulsants for social phobia (social anxiety disorder).	2001	11206035
Stereospecific effect of pregabalin on ectopic afferent discharges and neuropathic pain induced by sciatic nerve ligation in rats.	2001 Dec	11748408
Pharmacotherapy of social anxiety disorder at the turn of the millennium.	2001 Dec	11723633
Pregabalin enhances nonrapid eye movement sleep.	2001 Dec	11714899
Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V).	2001 Jan	11137386
Brain microdialysis and PK/PD correlation of pregabalin in rats.	2001 Jan-Jun	11554426
Upregulation of gamma-aminobutyric acid transporter expression: role of alkylated gamma-aminobutyric acid derivatives.	2001 Nov	11709066
Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.	2001 Nov	11690728
Effect of gabapentin-like compounds on development and maintenance of morphine-induced conditioned place preference.	2001 Oct	11605097
Inhibition of neuronal Ca(2+) influx by gabapentin and pregabalin in the human neocortex.	2002 Feb	11804619
Gateways to Clinical Trials. June 2002.	2002 Jun	12168506
Novel anticonvulsant medications in development.	2002 Oct	12387702
Progress report on new antiepileptic drugs: a summary of the Sixth Eilat Conference (EILAT VI).	2002 Sep	12350382
Protein 4.1N is required for translocation of inositol 1,4,5-trisphosphate receptor type 1 to the basolateral membrane domain in polarized Madin-Darby canine kidney cells.	2003 Feb 7	12444087
An enantioselective synthesis of (S)-(+)-3-aminomethyl-5-methylhexanoic acid via asymmetric hydrogenation.	2003 Jul 11	12839471
Exposure-response analysis of pregabalin add-on treatment of patients with refractory partial seizures.	2003 Jun	12811359
Gateways to clinical trials.	2003 Sep	14571286
Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial.	2004 Dec 14	15596757
Pregabalin (Pfizer).	2004 Jan	14983979
Highly selective asymmetric hydrogenation using a three hindered quadrant bisphosphine rhodium catalyst.	2004 May 19	15137752
Gateways to clinical trials.	2004 Nov	15632957
Gateways to clinical trials.	2004 Oct	15605126
Progress report on new antiepileptic drugs: a summary of the Seventh Eilat Conference (EILAT VII).	2004 Sep-Oct	15570674
The biology and pharmacology of calcium channel alpha2-delta proteins Pfizer Satellite Symposium to the 2003 Society for Neuroscience Meeting. Sheraton New Orleans Hotel, New Orleans, LA November 10, 2003.	2004 Summer	15317151
Pregabalin: in the treatment of postherpetic neuralgia.	2005	15610058

Patents

Sample Use Guides

In Vivo Use Guide

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy: The maximum recommended dose is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Postherpetic Neuralgia: The recommended dose is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Adjunctive Therapy for Adult Patients with Partial Onset Seizures: LYRICA at doses of 150 to 600 mg/day has been shown to be effective as adjunctive therapy in the treatment of partial onset seizures in adults. Both the efficacy and adverse event profiles of In general, it is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). Management of Fibromyalgia: The recommended dose is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Neuropathic Pain Associated with Spinal Cord Injury: The recommended dose range is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability.

Route of Administration: Oral

In Vitro Use Guide

Unknown

Substance Class	Chemical Created by `admin` on `Sat Dec 16 18:24:48 GMT 2023` Edited by `admin` on `Sat Dec 16 18:24:48 GMT 2023`
Record UNII	3DA4H8E58A
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

PREGABALIN SODIUM

Common Name

English

HEXANOIC ACID, 3-(AMINOMETHYL)-5-METHYL-, MONOSODIUM SALT, (3S)-

Systematic Name

English

HEXANOIC ACID, 3-(AMINOMETHYL)-5-METHYL-, SODIUM SALT (1:1), (3S)-

Systematic Name

English

Code System Code Type Description

CAS

914254-22-1

Created by admin on Sat Dec 16 18:24:48 GMT 2023 , Edited by admin on Sat Dec 16 18:24:48 GMT 2023

PRIMARY

PUBCHEM

23669189

Created by admin on Sat Dec 16 18:24:48 GMT 2023 , Edited by admin on Sat Dec 16 18:24:48 GMT 2023

PRIMARY

FDA UNII

3DA4H8E58A

Created by admin on Sat Dec 16 18:24:48 GMT 2023 , Edited by admin on Sat Dec 16 18:24:48 GMT 2023

PRIMARY

Related Record Type Details


					55JG375S6M

PREGABALIN

PARENT -> SALT/SOLVATE

Amount:

Related Record Type Details


					55JG375S6M

PREGABALIN

ACTIVE MOIETY

Amount:

AE	Significance	Dose	Population
Headache	mild, 2 patients	600 mg single, oral Highest studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: https://pubmed.ncbi.nlm.nih.gov/30349198	healthy, 24.8 years n = 10 Health Status: healthy Age Group: 24.8 years Sex: M Population Size: 10 Sources: https://pubmed.ncbi.nlm.nih.gov/30349198
Dizziness	mild, 4 patients	600 mg single, oral Highest studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: https://pubmed.ncbi.nlm.nih.gov/30349198	healthy, 24.8 years n = 10 Health Status: healthy Age Group: 24.8 years Sex: M Population Size: 10 Sources: https://pubmed.ncbi.nlm.nih.gov/30349198
Dysarthria	moderate, 1 patient	600 mg single, oral Highest studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: https://pubmed.ncbi.nlm.nih.gov/30349198	healthy, 24.8 years n = 10 Health Status: healthy Age Group: 24.8 years Sex: M Population Size: 10 Sources: https://pubmed.ncbi.nlm.nih.gov/30349198
Nausea	moderate, 1 patient	600 mg single, oral Highest studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: https://pubmed.ncbi.nlm.nih.gov/30349198	healthy, 24.8 years n = 10 Health Status: healthy Age Group: 24.8 years Sex: M Population Size: 10 Sources: https://pubmed.ncbi.nlm.nih.gov/30349198
Vision blurred	moderate, 1 patient	600 mg single, oral Highest studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: https://pubmed.ncbi.nlm.nih.gov/30349198	healthy, 24.8 years n = 10 Health Status: healthy Age Group: 24.8 years Sex: M Population Size: 10 Sources: https://pubmed.ncbi.nlm.nih.gov/30349198
Abnormal thinking	0.31% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Constipation	0.31% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Diarrhea	0.31% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Incoordination	0.31% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Ataxia	0.41% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Infection	0.41% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Neuropathy	0.41% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Tremor	0.41% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Peripheral edema	0.61% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Confusion	0.72% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Dry mouth	0.72% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Nausea	0.72% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Amblyopia	0.82% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Asthenia	0.82% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Headache	1.12% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Somnolence	2.76% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF
Dizziness	3.47% Disc. AE	150 mg 1 times / day steady, oral Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF	unhealthy, adult n = 979 Health Status: unhealthy Age Group: adult Population Size: 979 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_medr.PDF

Details

SMILES

InChI

DescriptionSources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdfCurator's Comment: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/17126531

CNS Activity

Originator

Approval Year

Targets

Conditions

Approved Use

Launch Date

Approved Use

Launch Date

Approved Use

Launch Date

Approved Use

Launch Date

Cmax

AUC

T1/2

Doses

AEs

Overview

OverviewOther

Drug as perpetrator​

Drug as victim

Tox targets

Sourcing

PubMed

Patents

Sample Use Guides

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf
Curator's Comment: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/17126531

C_max

T_1/2

Drug as perpetrator