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)
Pulmonary function test decreased13.19.01.001--Not Available
Hyperlipidaemia14.08.03.001--
Sensorimotor disorder17.05.03.0090.000052%Not Available
Urinary tract pain20.02.03.0130.000114%
Urine analysis abnormal13.13.02.008--Not Available
Renal impairment20.01.03.010--Not Available
Sinus disorder22.04.06.0020.000571%
Congenital arterial malformation24.03.03.012; 03.07.09.002--Not Available
Congenital genitourinary abnormality21.15.02.002; 20.08.03.001; 03.06.02.002--Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.001291%Not Available
Increased bronchial secretion22.12.01.002--Not Available
Muscle contracture15.03.05.0240.000078%Not Available
Urethritis noninfective20.07.02.002--Not Available
Facial spasm17.04.03.0100.000078%Not Available
Cystitis noninfective20.03.02.001--
Chorioretinopathy06.09.01.0060.000182%Not Available
Metamorphopsia17.17.01.020; 06.02.06.0140.000052%Not Available
Lichenoid keratosis23.01.01.004--Not Available
Complex regional pain syndrome12.01.12.004; 17.02.07.0100.000394%Not Available
Breakthrough pain16.32.03.016; 08.01.08.0260.000845%Not Available
Oral mucosa erosion07.05.06.0090.000052%Not Available
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Bronchial disorder22.03.02.0090.000104%Not Available
Head titubation17.01.06.0060.000052%Not Available
Ulcerative keratitis10.02.01.021; 06.04.02.004--
Brachial plexopathy17.09.03.0110.000052%
Infusion site haemorrhage24.07.01.058; 12.07.05.018; 08.02.05.018--Not Available
Suicidal behaviour19.12.01.0060.000311%Not Available
Loose tooth07.09.05.0090.000114%Not Available
Cardiovascular insufficiency02.11.01.011; 24.06.03.0050.000104%Not Available
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