Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gabapentin
Drug ID BADD_D00981
Description Gabapentin is a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid ([GABA]) that was first approved for use in the United States in 1993.[L8717] It was originally developed as a novel anti-epileptic for the treatment of certain types of seizures[A186277,A186143] - today it is also widely used to treat neuropathic pain.[A14097,A186179] Gabapentin has some stark advantages as compared with other anti-epileptics, such as a relatively benign adverse effect profile, wide therapeutic index, and lack of appreciable metabolism making it unlikely to participate in pharmacokinetic drug interactions.[A186143,A185981,L8717]. It is structurally and functionally related to another GABA derivative, [pregabalin].
Indications and Usage In the United States, gabapentin is officially indicated for the treatment of postherpetic neuralgia in adults and for the adjunctive treatment of partial-onset seizures, with or without secondary generalization, in patients 3 years of age and older.[L8717] In Europe, gabapentin is indicated for adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalization, in patients 6 years of age and older and as monotherapy in patients 12 years of age and older. It is also used in adults for the treatment of various types of peripheral neuropathic pain, such as painful diabetic neuropathy.[L8732]
Marketing Status approved; investigational
ATC Code N02BF01
DrugBank ID DB00996
KEGG ID D00332
MeSH ID D000077206
PubChem ID 3446
TTD Drug ID D0J0ZS
NDC Product Code 72789-055; 72888-132; 76420-235; 80425-0031; 80425-0097; 80425-0182; 82009-071; 52133-0025; 62331-031; 64220-211; 69617-002; 71574-121; 71901-609; 16714-332; 25000-103; 42385-974; 43602-466; 49483-607; 51407-047; 0228-2636; 52427-815; 53002-3423; 55289-959; 55700-584; 60687-591; 61919-640; 62756-202; 63187-006; 63187-010; 63187-810; 63629-7666; 63629-8490; 63739-560; 63739-591; 67877-429; 68001-412; 68071-5193; 68382-205; 68788-7822; 68788-7839; 68788-8176; 70010-926; 70518-0810; 70518-1760; 71093-120; 71205-317; 71205-485; 71205-619; 71205-638; 71335-0351; 71335-1007; 71335-1132; 71335-1200; 71335-1269; 71335-1496; 71610-044; 71610-621; 72789-127; 76282-706; 80425-0286; 83301-0002; 45963-556; 57884-0010; 65977-0054; 0071-0803; 16714-504; 42385-972; 43602-470; 50383-311; 50383-351; 51224-219; 51407-048; 51407-049; 52427-850; 53002-1538; 55700-780; 55700-950; 60687-518; 60760-088; 60760-814; 61919-387; 62756-139; 63187-372; 63187-392; 63629-8485; 63629-8487; 63739-236; 65162-102; 65862-524; 67877-428; 68071-3445; 69367-344; 70010-927; 70518-3330; 71093-122; 71205-373; 71205-533; 71335-0073; 71335-1287; 71335-2004; 71610-057; 71610-060; 71610-088; 71610-166; 71610-410; 71610-426; 0615-8132; 0615-8233; 0615-8340; 76420-234; 80425-0128; 83301-0001; 42765-018; 65862-523; 16714-663; 17856-0698; 42806-509; 42806-510; 43353-075; 43353-081; 43353-864; 43602-467; 43602-469; 45865-122; 49483-606; 50090-0949; 50090-3915; 50228-178; 50268-325; 51224-019; 55154-8193; 55154-8195; 59088-725; 59762-5050; 60687-602; 62756-137; 62756-138; 63187-909; 65862-200; 68071-2308; 68071-2600; 68071-2883; 68071-2907; 68462-126; 68788-7838; 68788-8475; 69097-811; 69097-814; 69367-131; 69367-133; 70518-1469; 70518-1544; 70518-2323; 70518-2912; 70518-2970; 70518-3755; 71205-932; 71335-1012; 71335-1655; 71610-198; 72189-394; 53746-101; 55154-3366; 59762-4135; 60760-605; 61919-350; 61919-417; 63187-057; 63629-8488; 63739-902; 64380-867; 68788-7024; 68788-7774; 68788-8468; 68788-8476; 70010-109; 70518-2911; 70518-3708; 71205-766; 71335-0254; 71335-0820; 71335-0993; 71335-1198; 71610-072; 72162-1813; 72189-419; 76420-047; 80425-0158; 82982-049; 82982-067; 17337-0415; 45963-557; 49452-3241; 65862-198; 66651-901; 0071-0401; 68554-0128; 82393-212; 16714-661; 31722-167; 45963-555; 49483-605; 50090-5961; 50228-180; 53002-4423; 55154-7993; 61919-982; 63187-148; 63187-983; 63739-903; 65841-705; 65841-706; 67296-1536; 68071-4978; 69367-134; 69367-135; 69367-346; 70010-118; 70518-3140; 70934-284; 70934-933; 71205-160; 71205-514; 71205-671; 71205-808; 71205-931; 71335-1018; 71335-1991; 71610-090; 71610-188; 72189-392; 0615-8342; 72888-104; 76282-405; 80425-0032; 80425-0033; 80425-0149; 0904-6665; 0228-2637; 65862-199; 68981-009; 71052-176; 0071-2012; 16571-868; 31722-149; 42385-973; 43602-471; 45865-405; 45865-498; 45865-549; 50090-3200; 50090-4445; 50090-4893; 50228-177; 50436-0223; 52427-804; 52427-890; 55700-949; 60760-066; 60760-740; 61919-660; 62207-927; 63187-056; 63187-149; 63187-248; 63629-3063; 63629-8489; 63629-8491; 63629-8492; 64380-868; 68071-2206; 68788-7848; 68788-8199; 69097-813; 69097-815; 69844-055; 69844-056; 70010-228; 70518-2493; 70518-3103; 70518-3329; 70934-950; 70934-953; 71093-111; 71093-162; 71335-1199; 71335-1453; 71335-1997; 71335-2053; 71610-135; 71610-667; 72189-092; 72189-313; 72189-384; 72888-131; 76282-323; 80425-0035; 80425-0082; 80425-0150; 82009-072
UNII 6CW7F3G59X
Synonyms Gabapentin | 1-(Aminomethyl)cyclohexaneacetic Acid | Neurontin | Gabapentin Hexal | Convalis | Gabapentin-Ratiopharm | Gabapentin Ratiopharm | Novo-Gabapentin | Novo Gabapentin | NovoGabapentin | PMS-Gabapentin | Apo-Gabapentin | Apo Gabapentin | ApoGabapentin | Gabapentin Stada
Chemical Information
Molecular Formula C9H17NO2
CAS Registry Number 60142-96-3
SMILES C1CCC(CC1)(CC(=O)O)CN
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Increased viscosity of upper respiratory secretion22.12.03.0080.000023%Not Available
Infantile back arching15.03.05.018; 18.04.01.0170.000010%Not Available
End stage renal disease20.01.03.0190.000021%Not Available
Tongue discomfort07.14.02.0190.000028%Not Available
Angiolipoma16.18.01.011; 15.09.01.0100.000010%Not Available
Behaviour disorder19.01.01.0050.000067%Not Available
Bell's palsy17.04.03.011--Not Available
Dilated cardiomyopathy02.04.01.017--Not Available
Drug effective for unapproved indication12.09.02.001; 08.06.01.0370.000460%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.014419%Not Available
Drug use disorder19.07.06.0120.000106%Not Available
Drug-disease interaction08.06.03.0120.000010%Not Available
Dyskinesia neonatal18.04.04.014; 17.01.02.0290.000010%Not Available
Eyelid myoclonus06.05.01.005; 17.12.03.0340.000026%Not Available
Fixed eruption08.01.06.025; 23.03.05.008; 10.01.01.0370.000026%Not Available
Focal dyscognitive seizures17.12.02.0050.000026%Not Available
Food refusal19.09.03.003; 14.03.01.0140.000023%Not Available
Gait inability17.02.05.069; 08.01.02.0110.000239%Not Available
Graves' disease06.09.04.009; 05.02.02.009; 10.04.08.0140.000010%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hypotony maculopathy12.02.02.013; 06.09.03.0320.000021%Not Available
Idiopathic neutropenia01.02.03.0050.000026%Not Available
Inadequate analgesia12.02.20.006; 08.06.01.0400.000059%Not Available
Ligamentum flavum hypertrophy17.10.01.026; 15.07.02.0090.000010%Not Available
Mucosal disorder08.01.06.029--Not Available
Myocardial injury02.04.02.0460.000021%Not Available
Neonatal intestinal obstruction18.04.11.010; 07.13.01.0180.000010%Not Available
Neonatal respiratory distress22.11.02.015; 18.04.10.0040.000010%Not Available
Neonatal seizure18.04.04.019; 17.12.03.0380.000016%Not Available
Peripheral nerve lesion17.09.02.0190.000010%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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