Drug
Gabapentin Enacarbil
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Toxicity To Various Agents | 594 | 26.3 | 33.0 | signal |
| 2 | Completed Suicide | 277 | 24.5 | 27.0 | signal |
| 3 | Restless Legs Syndrome | 56 | 22.9 | 23.3 | signal |
| 4 | Full Blood Count Abnormal | 32 | 22.6 | 22.8 | signal |
| 5 | Myoclonus | 33 | 20.6 | 20.8 | signal |
| 6 | Cardio-respiratory Arrest | 110 | 19.4 | 20.2 | signal |
| 7 | Sleep Disorder Due To A General Medical Condition | 34 | 15.6 | 15.8 | signal |
| 8 | Appendicitis | 17 | 13.6 | 13.6 | signal |
| 9 | Accidental Overdose | 66 | 13.4 | 13.7 | signal |
| 10 | Sputum Discoloured | 16 | 12.6 | 12.6 | signal |
| 11 | Drug Abuse | 138 | 12.2 | 12.8 | signal |
| 12 | Drug Withdrawal Syndrome Neonatal | 21 | 10.4 | 10.5 | signal |
| 13 | Neuralgia | 34 | 10.4 | 10.5 | signal |
| 14 | Ventricular Fibrillation | 15 | 10.0 | 10.0 | signal |
| 15 | Sensory Disturbance | 21 | 9.7 | 9.7 | signal |
| 16 | Impaired Driving Ability | 14 | 9.1 | 9.2 | signal |
| 17 | Cardiogenic Shock | 15 | 7.8 | 7.8 | signal |
| 18 | Product Odour Abnormal | 10 | 7.1 | 7.2 | signal |
| 19 | Hyperlipidaemia | 11 | 6.8 | 6.8 | signal |
| 20 | Bacterial Infection | 17 | 6.8 | 6.8 | signal |
| 21 | Therapeutic Response Unexpected | 38 | 6.3 | 6.3 | signal |
| 22 | Initial Insomnia | 8 | 5.8 | 5.8 | signal |
| 23 | Dyskinesia | 29 | 5.3 | 5.3 | signal |
| 24 | Incorrect Route Of Product Administration | 12 | 5.3 | 5.3 | signal |
| 25 | Bladder Disorder | 7 | 5.2 | 5.2 | signal |
| 26 | Ulcer | 11 | 5.1 | 5.1 | signal |
| 27 | Sleep Apnoea Syndrome | 13 | 5.0 | 5.1 | signal |
| 28 | Therapeutic Response Shortened | 21 | 4.9 | 4.9 | signal |
| 29 | Respiratory Depression | 8 | 4.8 | 4.8 | signal |
| 30 | Sedation | 17 | 4.8 | 4.9 | signal |
| 31 | Dyspnoea Exertional | 24 | 4.7 | 4.8 | signal |
| 32 | Seasonal Allergy | 9 | 4.7 | 4.7 | signal |
| 33 | Chronic Obstructive Pulmonary Disease | 33 | 4.7 | 4.7 | signal |
| 34 | Somnolence | 125 | 4.6 | 4.8 | signal |
| 35 | Gout | 11 | 4.5 | 4.6 | signal |
| 36 | Drug Ineffective For Unapproved Indication | 34 | 4.5 | 4.6 | signal |
| 37 | Poor Quality Product Administered | 6 | 4.4 | 4.4 | signal |
| 38 | Spinal Operation | 7 | 4.3 | 4.3 | signal |
| 39 | Hereditary Angioedema | 6 | 4.2 | 4.2 | signal |
| 40 | Muscle Spasticity | 7 | 4.2 | 4.2 | signal |
| 41 | Wheezing | 32 | 4.0 | 4.0 | signal |
| 42 | Multiple Organ Dysfunction Syndrome | 15 | 4.0 | 4.0 | signal |
| 43 | Therapeutic Product Effect Incomplete | 38 | 4.0 | 4.0 | signal |
| 44 | Affect Lability | 5 | 3.8 | 3.8 | signal |
| 45 | Inability To Afford Medication | 5 | 3.8 | 3.8 | signal |
| 46 | Intentional Product Misuse | 44 | 3.8 | 3.8 | signal |
| 47 | Middle Insomnia | 9 | 3.6 | 3.6 | signal |
| 48 | Abnormal Dreams | 13 | 3.5 | 3.5 | signal |
| 49 | Bedridden | 6 | 3.4 | 3.4 | signal |
| 50 | Activities Of Daily Living Impaired | 9 | 3.3 | 3.3 | signal |
| 51 | Drug Effective For Unapproved Indication | 13 | 3.3 | 3.3 | signal |
| 52 | Limb Injury | 12 | 3.3 | 3.3 | signal |
| 53 | Product Prescribing Issue | 9 | 3.3 | 3.3 | signal |
| 54 | Disturbance In Attention | 23 | 3.2 | 3.2 | signal |
| 55 | Pharyngeal Swelling | 4 | 3.1 | 3.1 | no signal |
| 56 | Asthma | 46 | 3.0 | 3.1 | signal |
| 57 | Nightmare | 14 | 3.0 | 3.0 | signal |
| 58 | Withdrawal Syndrome | 17 | 3.0 | 3.0 | signal |
| 59 | Feeling Abnormal | 95 | 2.9 | 3.0 | signal |
| 60 | Mental Impairment | 9 | 2.7 | 2.8 | signal |
| 61 | Feeling Jittery | 7 | 2.7 | 2.7 | signal |
| 62 | Product Packaging Quantity Issue | 4 | 2.7 | 2.7 | no signal |
| 63 | Mania | 6 | 2.7 | 2.7 | signal |
| 64 | Medication Error | 20 | 2.7 | 2.7 | signal |
| 65 | Prescribed Underdose | 7 | 2.6 | 2.6 | signal |
| 66 | Intentional Drug Misuse | 7 | 2.4 | 2.4 | signal |
| 67 | Schizophrenia | 4 | 2.4 | 2.4 | no signal |
| 68 | Product Dispensing Error | 7 | 2.4 | 2.4 | signal |
| 69 | Fracture | 6 | 2.3 | 2.4 | no signal |
| 70 | Irritability | 19 | 2.3 | 2.3 | signal |
| 71 | Serotonin Syndrome | 6 | 2.3 | 2.3 | no signal |
| 72 | Dystonia | 6 | 2.3 | 2.3 | no signal |
| 73 | Suicidal Ideation | 28 | 2.3 | 2.3 | signal |
| 74 | Product Physical Issue | 6 | 2.2 | 2.2 | no signal |
| 75 | Knee Arthroplasty | 6 | 2.1 | 2.1 | no signal |
| 76 | Blood Glucose Fluctuation | 3 | 2.0 | 2.0 | no signal |
| 77 | Multiple Sclerosis | 13 | 2.0 | 2.0 | signal |
| 78 | Colon Cancer | 4 | 2.0 | 2.0 | no signal |
| 79 | Blood Count Abnormal | 4 | 1.9 | 1.9 | no signal |
| 80 | Injection Site Discolouration | 3 | 1.8 | 1.8 | no signal |
| 81 | Multiple Sclerosis Relapse | 16 | 1.7 | 1.7 | no signal |
| 82 | Drug Administration Error | 7 | 1.7 | 1.7 | no signal |
| 83 | Product Taste Abnormal | 3 | 1.7 | 1.7 | no signal |
| 84 | Akathisia | 3 | 1.6 | 1.6 | no signal |
| 85 | Extra Dose Administered | 8 | 1.5 | 1.5 | no signal |
| 86 | Drug Dispensing Error | 3 | 1.4 | 1.4 | no signal |
| 87 | Wrong Technique In Product Usage Process | 35 | 1.3 | 1.3 | no signal |
| 88 | Suicide Attempt | 10 | 1.2 | 1.2 | no signal |
| 89 | Wrong Technique In Drug Usage Process | 6 | 1.2 | 1.2 | no signal |
| 90 | Product Storage Error | 13 | 1.1 | 1.1 | no signal |
| 91 | Intentional Self-injury | 3 | 1.1 | 1.1 | no signal |
| 92 | Injection Site Bruising | 9 | 0.8 | 0.8 | no signal |
| 93 | Product Adhesion Issue | 4 | 0.8 | 0.8 | no signal |
| 94 | Intentional Overdose | 7 | 0.8 | 0.8 | no signal |
| 95 | Drug Withdrawal Syndrome | 8 | 0.7 | 0.7 | no signal |
| 96 | Bladder Cancer | 4 | 0.5 | 0.5 | no signal |