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 used for the management of neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, and postherpetic neuralgia. It is not approved for the management of fibromyalgia or as adjuntive therapy for adult partial onset seizures.[FDA label]
Marketing Status Prescription
ATC Code N03AX16
DrugBank ID DB00230
KEGG ID D02716
MeSH ID D000069583
PubChem ID 5486971
TTD Drug ID D00WUF
NDC Product Code 69238-1315; 72189-032; 71335-1476; 0228-2860; 59762-1354; 63539-014; 59762-1364; 72189-028; 55700-956; 59762-1348; 64980-413; 71335-1791; 71335-2012; 71335-1744; 76420-124; 55700-827; 0071-1017; 72189-269; 43598-297; 72658-0811; 71205-556; 53869-1473; 80425-0129; 69539-012; 80425-0124; 55700-804; 71335-1745; 72189-035; 72189-023; 76420-099; 69097-957; 69367-326; 60219-1317; 76282-574; 27808-237; 55700-805; 80425-0123; 68788-7524; 76282-572; 76420-097; 76420-100; 59762-1576; 0071-1012; 42419-019; 76420-121; 42385-308; 76420-123; 71205-298; 69097-955; 63629-3369; 64980-414; 71335-1790; 72658-0812; 69097-956; 71205-876; 69097-961; 66174-0031; 69367-329; 72189-251; 80425-0185; 60219-1316; 72189-033; 60219-1314; 66651-915; 0228-2858; 60219-1310; 31722-614; 43598-296; 69238-1317; 72658-0849; 72658-0808; 55154-2431; 76420-118; 31722-615; 72658-0813; 0071-1018; 27808-235; 69539-015; 69367-330; 71610-356; 47781-381; 72606-008; 60687-506; 51407-510; 0228-2861; 0904-7004; 71335-1300; 43353-263; 47335-691; 63304-048; 71335-1822; 69097-954; 0071-1026; 60760-205; 62350-0072; 76420-098; 53869-1016; 55154-2430; 70518-2763; 72189-021; 71335-1505; 60219-1312; 63629-8198; 71335-2015; 71610-316; 53869-1018; 0071-1019; 0904-7005; 71335-2000; 0071-1016; 72888-051; 70518-2571; 71610-351; 0904-7002; 62332-121; 71610-358; 45865-126; 69367-331; 55700-904; 50436-0325; 0904-7003; 71610-331; 63539-024; 68788-7523; 76282-569; 70518-2568; 31722-616; 71610-334; 55700-817; 15894-0016; 71205-875; 71335-1459; 72189-020; 60687-495; 60687-517; 76282-568; 72888-049; 66039-926; 80425-0025; 47335-688; 63629-8196; 69238-1312; 72205-013; 68788-7656; 71205-304; 46708-125; 72658-0814; 69539-128; 70518-2948; 71205-338; 60687-484; 71205-871; 64980-417; 80425-0029; 53869-1014; 71610-365; 80425-0147; 53869-1010; 43353-414; 71610-333; 71610-328; 71335-1792; 63629-4181; 70518-2745; 50228-350; 43598-291; 72643-010; 71335-1758; 60219-1315; 50370-0013; 65015-857; 72189-034; 80425-0026; 66577-034; 80425-0152; 67877-466; 47335-687; 50090-5071; 0228-2862; 67877-465; 76282-573; 55700-964; 63629-8199; 43598-295; 43353-264; 47781-379; 70518-2980; 31722-611; 63629-8208; 60760-486; 64980-412; 16812-003; 70518-2525; 69539-018; 59762-1360; 59285-002; 0071-1027; 0228-2859; 80425-0166; 69238-1314; 60219-1311; 76282-570; 71205-869; 72640-002; 69539-129; 27808-236; 47781-380; 67877-467; 72606-007; 80425-0028; 76420-117; 70518-2762; 53869-1013; 72189-164; 72658-0809; 60760-509; 65862-790; 47335-690; 61919-503; 63629-8197; 71205-323; 80425-0116; 72189-019; 0071-1020; 50090-5038; 50090-5177; 27808-239; 55700-891; 70518-3345; 62332-123; 60219-1313; 70518-2689; 69367-325; 70518-2569; 67877-463; 69238-1311; 71610-317; 69367-328; 50228-355; 51407-511; 68788-7521; 70518-2364; 17337-0421; 70518-2290; 0071-1014; 69539-011; 50228-357; 69097-962; 69097-959; 0071-1013; 71610-335; 43598-294; 55289-257; 71610-319; 43353-675; 76282-575; 46708-120; 71205-396; 55111-882; 0071-1015; 43598-293; 47335-693; 72189-328; 63629-8195; 72189-045; 62332-119; 60687-473; 69238-1310; 59762-1342; 71610-071; 67877-468; 53869-1011; 72205-018; 62332-124; 0228-2857; 71610-329; 45865-108; 71610-330; 71610-361; 71205-608; 72205-017; 50228-354; 71205-873; 67877-462; 71610-357; 31722-612; 43598-298; 72205-012; 63629-8248; 62332-125; 68724-1235; 50228-356; 55289-569; 69238-1316; 60760-507; 59762-1351; 69097-958; 0228-2863; 69238-1313; 50228-351
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.0010.003893%Not Available
Abnormal faeces07.01.03.0010.000354%Not Available
Abnormal sensation in eye06.01.01.0010.000590%Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.001--Not Available
Accommodation disorder06.02.04.0010.000472%Not Available
Acidosis14.01.03.002--
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute psychosis19.03.01.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.004--Not Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure22.02.06.001; 14.01.04.004--Not Available
Adenoma benign16.02.02.001--Not Available
Adrenal insufficiency14.11.01.004; 05.01.02.001--
Affective disorder19.04.04.0010.001533%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.0010.006605%Not Available
Agitation19.06.02.001; 17.02.05.0120.010734%
Agitation neonatal19.06.02.007; 18.04.04.002; 17.02.05.0280.000236%Not Available
Agranulocytosis01.02.03.0010.002477%Not Available
Akathisia17.01.02.002; 19.06.02.006--
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
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