This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Gabapentin is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is indicated for: Postherpetic neuralgia in adults ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1 )
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Known hypersensitivity to gabapentin or its ingredients ( 4 )
Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established ( 5.1 ) Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately ( 5.2 ) Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired ( 5.3 , 5.4 ) Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinued ( 5.5 ) Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 5.6 ) Respiratory Depression: May occur with gabapentin when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate ( 5.7 ) Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events ( 5.8 ) 5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensit...
The following serious adverse reactions are discussed in greater detail in other sections: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.1) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.2) ] Somnolence/Sedation and Dizziness [see Warnings and Precautions (5.4) ] Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Respiratory Depression [see Warnings and Precautions (5.7) ] Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.8) ] Sudden and Unexplained Death in Patients with Epilepsy [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 8% and at least twice that for placebo) were: Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema ( 6.1 ) Epilepsy in patients > 12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus ( 6.1 ) Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility ( 6.1 ) To report SUSPECTED ADV...
Warnings and Precautions, Respiratory Depression ( 5.7 ) 04/2020
Source: FDA SPL label for Gabapentin (NuCare Pharmaceuticals,Inc.), effective 20250203. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 33,654 | 29,204 | 24,186 | 21,989 | 21,173 | 20,555 | 21,443 | 10,117 |
1,403 reports blaming this drug for every million Medicare prescriptions filled, which is 0.5× the typical drug on this site. (51,694 reports in 2024–2026, against 36,837,037 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 10/2025 | Class II | The Harvard Drug Group LLC | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . |
| 06/2025 | Class II | The Harvard Drug Group LLC | Defective container; blister packaging inadequately sealed. |
| 03/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| 03/2025 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Cross Contamination |
| 03/2025 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Cross Contamination |
| 04/2023 | Class III | The Harvard Drug Group | Product mixup: one foreign tablet found in product. |
| 02/2023 | Class III | Sciegen Pharmaceuticals Inc | Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. |
| 05/2020 | Class III | InvaGen Pharmaceuticals, Inc. | Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing. |
| 03/2020 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed |
| 12/2014 | Class II | Actavis Elizabeth LLC | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. |
| 12/2014 | Class II | Actavis Elizabeth LLC | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. |
| 12/2014 | Class II | Actavis Elizabeth LLC | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Settlements of $100M+ in which this drug (Neurontin) was a named product, as recorded by the Department of Justice. A settlement resolves allegations; civil settlements are not admissions and not findings of wrongdoing. They are shown because off-label promotion cases describe how the evidence many prescribers saw was shaped.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Gabapentin | 36,804,628 | $15 |
| Gralise | 12,576 | $995 |
| Neurontin | 11,760 | $1,578 |
| Gabapentin ER | 8,073 | $479 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.