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)
Hyperpathia17.02.07.015--Not Available
Substance abuse19.07.06.0180.000519%Not Available
Thyroid cancer16.24.03.001; 05.02.05.001--Not Available
Haematological malignancy16.21.01.002; 01.13.01.0030.000052%Not Available
Mixed liver injury09.01.07.0150.000078%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000659%Not Available
Pharyngeal disorder22.04.05.0070.000316%Not Available
Organising pneumonia22.01.02.0080.000156%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.000078%Not Available
Oral disorder07.05.01.0050.000306%Not Available
Head and neck cancer16.16.01.0030.000052%Not Available
Skin mass23.07.04.014--Not Available
Brain injury19.07.03.007; 17.11.01.0030.000337%Not Available
Intellectual disability19.21.06.001; 17.03.07.0010.000104%Not Available
Anorectal discomfort07.03.03.003--Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000545%Not Available
Brain stem stroke24.04.06.024; 17.08.01.0330.000052%Not Available
Terminal insomnia17.15.03.004; 19.02.01.0040.000176%Not Available
Acute kidney injury20.01.03.016--
Amputation stump pain08.01.08.025; 17.02.07.0180.000202%Not Available
Toxicity to various agents12.03.01.046--Not Available
Cold-stimulus headache17.14.01.0140.000176%Not Available
Functional gastrointestinal disorder07.11.01.0160.000078%Not Available
Slow speech19.19.02.004; 17.02.08.0160.000322%Not Available
Action tremor17.01.06.007--Not Available
White matter lesion24.04.06.027; 17.11.01.0090.000052%Not Available
Lacrimal structural disorder06.06.04.013--Not Available
Hepatic cancer16.07.02.004; 09.04.02.008--Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.010--Not Available
Diffuse alopecia23.02.02.0070.000114%Not Available
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