Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gabapentin enacarbil
Drug ID BADD_D00982
Description Gabapentin enacarbil is marketed under the name Horizant. It is a prodrug of gabapentin, and indicated in adults for the treatment of Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).
Indications and Usage For the treatment of adult Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB08872
KEGG ID D09539
MeSH ID C493250
PubChem ID 9883933
TTD Drug ID D05KBU
NDC Product Code 49187-0710; 70966-0011; 53451-0103; 53451-0101; 66039-945
UNII 75OCL1SPBQ
Synonyms 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid | gabapentin enacarbil | XP 12464 | XP12464 | XP-12464 | XP 10569 | XP10569 | XP-10569 | XP 11239 | XP11239 | XP-11239 | XP 13512 | XP13512 | XP-13512 | XP 11084 | XP11084 | XP-11084
Chemical Information
Molecular Formula C16H27NO6
CAS Registry Number 478296-72-9
SMILES CC(C)C(=O)OC(C)OC(=O)NCC1(CCCCC1)CC(=O)O
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)
Irritability08.01.03.011; 19.04.02.013-
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.004--
Libido decreased19.08.03.001; 21.03.02.005--
Loss of consciousness17.02.04.004--
Metabolic acidosis14.01.01.003--
Mood altered19.04.02.007--
Myocardial ischaemia02.02.02.008; 24.04.04.010--
Myoclonus17.02.05.008--
Nausea07.01.07.001--
Oedema08.01.07.006; 14.05.06.010--
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011-
Oral discomfort07.05.05.001--
Oral pain07.05.05.034-
Renal disorder20.01.02.002--
Respiratory depression17.02.05.047; 22.02.01.010--
Rhabdomyolysis15.05.05.002-
Sedation17.02.04.005--
Somnolence17.02.04.006; 19.02.05.003-
Suicidal ideation19.12.01.003-
Swelling08.01.03.015--
Tongue spasm07.14.02.008--
Tremor17.01.06.002-
Urticaria10.01.06.001; 23.04.02.001-
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred06.02.06.007; 17.17.01.010--
Weight increased13.15.01.006--
Withdrawal syndrome08.06.02.012; 19.07.06.023--
Balance disorder08.01.03.081; 17.02.02.007---
Dysstasia08.01.03.089; 15.03.05.011; 17.02.02.012--
Musculoskeletal stiffness15.03.05.027--
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