Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pregabalin
Drug ID BADD_D01835
Description Pregabalin is structurally similar to gamma-aminobutyric acid (GABA) - an inhibitory neurotransmitter.[A173995] It may be used to manage neuropathic pain, postherpetic neuralgia, and fibromyalgia among other conditions.[A187190] Although as per the FDA Label the mechanism of action has not been definitively defined, there is evidence that pregabalin exerts its effects by binding to the α2δ subunit of voltage-dependent calcium channels.[A187190][L7066] Pregabalin is marketed by Pfizer under the trade name Lyrica and Lyrica Cr (extended release).[L1006][L7066] It may have dependence liability if misused but the risk appears to be highest in patients with current or past substance use disorders.[A31161]
Indications and Usage Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury, and as adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.[L7066]
Marketing Status approved; investigational
ATC Code N02BF02
DrugBank ID DB00230
KEGG ID D02716
MeSH ID D000069583
PubChem ID 5486971
TTD Drug ID D00WUF
NDC Product Code 75834-303; 76282-569; 76282-572; 76420-118; 76420-122; 76420-221; 76420-248; 80425-0025; 80425-0129; 80425-0178; 0904-6991; 0904-7003; 42419-019; 53869-1014; 61294-9991; 64220-169; 65862-761; 65862-790; 0071-1019; 81999-0003; 82924-001; 25000-180; 27808-238; 31722-614; 43353-263; 43353-876; 43547-510; 43598-293; 46708-120; 50228-356; 0228-2859; 55154-8097; 55700-964; 59762-1346; 59762-1348; 59762-1354; 60505-3793; 60687-495; 62332-121; 63629-8208; 64980-410; 65862-759; 65862-760; 67877-466; 67877-469; 68788-7527; 69367-325; 69367-329; 69539-127; 70518-2745; 70518-2763; 71205-323; 71205-556; 71209-034; 71209-037; 71335-1792; 71610-318; 71610-319; 71610-350; 71610-351; 71610-352; 71610-358; 72189-019; 72205-018; 72606-006; 72658-0809; 72658-0849; 76282-568; 76420-095; 76420-117; 80425-0026; 80425-0027; 80425-0030; 80425-0170; 0904-7004; 0904-7005; 53869-1018; 53869-1019; 63415-0121; 66039-926; 0071-1020; 47335-687; 50228-351; 0228-2856; 0228-2860; 60505-3797; 60687-506; 60760-205; 60760-591; 63629-8239; 63629-8248; 64980-416; 68788-7522; 68788-8359; 69238-1315; 69539-012; 69539-016; 70518-3642; 70518-3647; 71335-1758; 71335-2000; 71610-071; 71610-316; 71610-333; 71610-361; 71610-618; 72162-1545; 72162-1548; 72189-115; 72606-007; 72606-008; 80425-0028; 50370-0013; 53869-1012; 53869-1016; 55111-882; 59285-002; 65862-758; 66174-0031; 0071-1012; 27808-235; 31722-610; 31722-615; 43598-297; 46708-124; 46708-125; 47335-692; 47335-693; 0228-2858; 55154-8098; 55700-774; 55700-891; 55700-955; 55700-956; 59762-1342; 59762-1364; 60219-1315; 60760-507; 62135-445; 62135-447; 62332-123; 62332-126; 63629-8196; 64980-413; 64980-415; 67877-464; 67877-467; 67877-468; 69097-957; 69097-961; 69238-1313; 69367-324; 69367-330; 69539-128; 70518-3646; 71205-396; 71205-873; 71209-038; 71335-1505; 71610-320; 71610-365; 71610-619; 71610-719; 72162-1546; 72162-2026; 72189-241; 72205-077; 55700-805; 59762-1360; 60219-1317; 60505-3799; 60760-485; 62135-446; 62332-124; 64980-411; 64980-414; 64980-417; 67877-462; 68788-7521; 68788-8383; 68788-8472; 69097-958; 69097-962; 69238-1311; 70518-2568; 70518-2571; 70518-2892; 70518-2980; 71205-304; 71335-1751; 71335-2012; 71335-9740; 71610-314; 71610-330; 72162-1541; 72162-2024; 72162-2028; 72189-033; 72205-016; 72205-017; 75834-297; 76420-247; 80425-0160; 80425-0307; 0904-7000; 0904-7001; 65862-763; 0071-1014; 0071-1015; 25000-185; 31722-612; 43353-840; 47335-689; 50228-357; 50228-463; 0228-2863; 59762-1344; 59762-1351; 60219-1311; 60505-3795; 60505-3798; 62332-122; 65862-765; 67877-457; 68788-8391; 69238-1316; 69539-015; 70518-2483; 70518-2525; 70518-2762; 71205-298; 71205-694; 71205-733; 71205-874; 71335-1459; 71335-1475; 71335-1762; 71335-9671; 71610-328; 72162-1544; 72189-269; 72189-328; 72658-0811; 76282-575; 76420-119; 76420-121; 76420-123; 80425-0147; 80425-0277; 80425-0308; 0904-6992; 15894-0016; 16812-003; 62331-057; 69218-0300; 27808-239; 27808-241; 31722-616; 31722-617; 43598-291; 43598-298; 47335-691; 50090-6503; 0228-2857; 55700-775; 55700-827; 55700-904; 60219-1310; 62332-120; 63304-047; 63629-8199; 67877-463; 68071-2330; 69238-1310; 69539-011; 69539-018; 69539-129; 71205-608; 71205-872; 71209-039; 71335-1744; 71335-2030; 71335-9699; 72162-1542; 72162-1543; 72189-021; 72189-164; 72205-013; 72205-015; 75834-302; 76420-099; 76420-102; 76420-124; 80425-0116; 0904-7002; 53869-2347; 65862-762; 0071-1013; 0071-1018; 0071-1026
UNII 55JG375S6M
Synonyms Pregabalin | (S)-3-(aminomethyl)-5-methylhexanoic acid | 3-isobutyl GABA | 3 isobutyl GABA | GABA, 3-isobutyl | 3-(aminomethyl)-5-methylhexanoic acid | (R-)-3-isobutyl GABA | (S+)-3-isobutyl GABA | Lyrica | CI 1008 | 1008, CI | CI-1008 | CI1008
Chemical Information
Molecular Formula C8H17NO2
CAS Registry Number 148553-50-8
SMILES CC(C)CC(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)
Hypochloraemia14.05.08.003--Not Available
Hypochromic anaemia01.03.02.004--Not Available
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypoglycaemic coma05.06.03.004; 17.02.09.005; 14.06.03.0040.000130%Not Available
Hypohidrosis23.02.03.005; 08.01.03.029--
Hypokalaemia14.05.03.002--
Hypokinesia17.01.02.0090.001369%Not Available
Hypomagnesaemia14.04.02.001--
Hypomenorrhoea05.05.01.006; 21.01.02.002--Not Available
Hyponatraemia14.05.04.002--
Hypophosphataemia14.04.03.001--
Hypoproteinaemia14.10.01.003; 09.01.02.004--Not Available
Hyporeflexia17.02.01.0030.000078%
Hypotension24.06.03.002--
Hypothermia12.05.03.001; 08.05.01.0030.000674%
Hypothyroidism05.02.03.001; 14.11.01.012--
Hypotonia17.05.02.002; 15.05.04.008--Not Available
Hypotonic-hyporesponsive episode17.05.03.011; 12.02.11.0050.000052%Not Available
Hypoventilation22.02.01.0070.000156%Not Available
Hypovitaminosis14.12.01.0010.000052%Not Available
Hypoxia22.02.02.003--
Ichthyosis23.01.02.002; 03.05.01.004--Not Available
Ichthyosis acquired23.01.02.001--Not Available
IIIrd nerve paralysis17.04.02.003; 06.05.02.0110.000052%Not Available
Ileus07.13.01.0010.000389%
Ileus paralytic07.02.05.0010.000207%Not Available
Illusion19.10.05.0060.000233%Not Available
Immune system disorder10.02.01.0010.000508%Not Available
Immunoglobulins increased13.06.05.005--Not Available
Impaired gastric emptying07.02.02.0040.000337%
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