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Drug side effects

gabapentin Side Effects

The reactions most often reported to the FDA for gabapentin (also sold as Neurontin, Gralise), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

351,750
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2001 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of gabapentin come from 351,750 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 351,750 reports to the FDA Adverse Event Reporting System (FAERS) for gabapentin (Neurontin): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

351,750

Reports Mentioning Death

33,007

9.4% of reports — not proof the medicine caused the death

Hospitalizations

103,305

29.4% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

FATIGUE
24,397
NAUSEA
21,946
PAIN
20,744
DIARRHOEA
17,454
HEADACHE
17,287
DIZZINESS
15,976
FALL
15,168
DYSPNOEA
13,728
VOMITING
11,709
ASTHENIA
11,625
PAIN IN EXTREMITY
11,358
ARTHRALGIA
11,156
DEATH
10,701
MALAISE
10,514
PNEUMONIA
10,063
DRUG HYPERSENSITIVITY
9,998
DEPRESSION
9,996
ANXIETY
9,819

Who Reports Side Effects

Gender Distribution

Female 210,595 (65%)
Male 113,464 (35%)
Unknown 759

Age Distribution

0-17 4,860 (2%)
18-44 38,248 (17%)
45-64 96,477 (43%)
65-74 48,788 (22%)
75+ 36,209 (16%)

Reporting Trend by Year

2001 2025

Reactions in Death Reports

Top reactions reported in 33,007 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 10,662
COMPLETED SUICIDE 5,721
TOXICITY TO VARIOUS AGENTS 4,054
CARDIAC ARREST 1,731
PNEUMONIA 1,601
DRUG ABUSE 1,455
CARDIO-RESPIRATORY ARREST 1,412
OVERDOSE 1,181
DYSPNOEA 1,176
SEPSIS 1,137
NAUSEA 1,124
FATIGUE 1,018
PAIN 970
RENAL FAILURE 967
VOMITING 946
ACUTE KIDNEY INJURY 939
RESPIRATORY ARREST 930
FALL 863
ASTHENIA 861

Reactions in Hospitalization Reports

Top reactions in 103,305 reports where hospitalization was an outcome.

Reaction Reports
FALL 8,031
PNEUMONIA 7,773
NAUSEA 7,147
FATIGUE 6,724
DYSPNOEA 6,657
PAIN 6,276
DIARRHOEA 6,092
VOMITING 5,364
ASTHENIA 5,252
DIZZINESS 4,641
HEADACHE 4,536
PYREXIA 4,172
URINARY TRACT INFECTION 4,052
PAIN IN EXTREMITY 3,841
ACUTE KIDNEY INJURY 3,633
MALAISE 3,575
HYPOTENSION 3,506
CONFUSIONAL STATE 3,464

Compare gabapentin vs brivaracetam →

What the FAERS Data Reveals About gabapentin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 351,750 voluntary reports linked to gabapentin and its brand equivalents (Neurontin, Gralise), spanning 2001 through 2025. Of those, 33,007 (9.4%) listed death as an outcome and 103,305 (29.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 65% were female and 35% male; age distribution skews toward 45-64, with 96,477 reports in that bracket. The single most reported reaction is fatigue with 24,397 submissions, followed by nausea and pain.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.