HIGH-VOLUME · SEX-BALANCED
pregabalin Side Effects
pregabalin (also sold as Lyrica) is HIGH-VOLUME in this FAERS book #16 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 66% of sex-coded reports are female (158,869 F / 82,326 M).
Data updated 2026-05-15
- 264,092
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
pregabalin reporting skew - 66% of sex-coded reports are female (158,869 F / 82,326 M). Volume band HIGH-VOLUME #16 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for pregabalin (Lyrica): 264,092 FAERS rows (2004-2025). Top named reactions: PAIN, FATIGUE, DIZZINESS. Outcome stamps DEATH-HEAVY · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
PAIN leads 25,902 of 264,092 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (71,463 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (21,160 reports, 8.0%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 5,335 |
| TOXICITY TO VARIOUS AGENTS | 2,847 |
| FATIGUE | 1,626 |
| COMPLETED SUICIDE | 1,529 |
| PYREXIA | 1,528 |
| PNEUMONIA | 1,526 |
| VOMITING | 1,520 |
| DYSPNOEA | 1,425 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,359 |
| DIARRHOEA | 1,315 |
| NAUSEA | 1,285 |
| MALAISE | 1,257 |
| PAIN | 1,242 |
| DECREASED APPETITE | 1,166 |
| HYPERTENSION | 1,166 |
| HEADACHE | 1,134 |
| OVERDOSE | 1,123 |
| ASTHENIA | 1,107 |
| PRURITUS | 1,080 |
Reactions in Hospitalization Reports
Hospitalization mid-share (74,751, 28.3%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PAIN | 6,244 |
| FALL | 5,541 |
| NAUSEA | 5,260 |
| FATIGUE | 5,252 |
| PNEUMONIA | 5,032 |
| DYSPNOEA | 4,892 |
| VOMITING | 4,584 |
| MALAISE | 4,466 |
| HEADACHE | 4,313 |
| PYREXIA | 4,245 |
| DIARRHOEA | 4,221 |
| DIZZINESS | 3,996 |
| ASTHENIA | 3,859 |
| CONFUSIONAL STATE | 3,493 |
| ARTHRALGIA | 3,141 |
| PAIN IN EXTREMITY | 3,132 |
| CONDITION AGGRAVATED | 3,004 |
| SOMNOLENCE | 2,988 |
How to read pregabalin FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-MID)
FAERS holds 264,092 voluntary reports linked to pregabalin (Lyrica), 2004-2025. Death is listed on 21,160 (8.0%). Hospitalization appears on 74,751 (28.3%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with pregabalin
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 262,453 FAERS cases (Δ 1,639 lighter vs pregabalin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 257,862 FAERS cases (Δ 6,230 lighter vs pregabalin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 246,252 FAERS cases (Δ 17,840 lighter vs pregabalin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 245,754 FAERS cases (Δ 18,338 lighter vs pregabalin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.1 pp vs pregabalin's DEATH-HEAVY): CASELOAD · HOSP-MID.
pregabalin stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload MEGA-CASE and the label guide.