HIGH-VOLUME · SEX-BALANCED
baclofen Side Effects
baclofen (also sold as Lioresal, Gablofen) is HIGH-VOLUME in this FAERS book #91 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 66% of sex-coded reports are female (51,669 F / 26,068 M).
Data updated 2026-05-15
- 83,476
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
baclofen reporting skew - 66% of sex-coded reports are female (51,669 F / 26,068 M). Volume band HIGH-VOLUME #91 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for baclofen (Lioresal): 83,476 FAERS rows (2003-2025). Top named reactions: FATIGUE, PAIN, FALL. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
FATIGUE leads 6,149 of 83,476 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (27,054 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (6,213 reports, 7.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 1,910 |
| COMPLETED SUICIDE | 1,368 |
| TOXICITY TO VARIOUS AGENTS | 828 |
| CARDIAC ARREST | 342 |
| PNEUMONIA | 336 |
| CARDIO-RESPIRATORY ARREST | 245 |
| SEPSIS | 191 |
| RESPIRATORY ARREST | 188 |
| RESPIRATORY FAILURE | 181 |
| OVERDOSE | 164 |
| URINARY TRACT INFECTION | 157 |
| MULTIPLE SCLEROSIS | 154 |
| PAIN | 151 |
| FALL | 149 |
| PNEUMONIA ASPIRATION | 148 |
| DYSPNOEA | 143 |
| ASTHENIA | 132 |
| RENAL FAILURE | 129 |
| CONDITION AGGRAVATED | 124 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (27,326, 32.7% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FALL | 2,484 |
| URINARY TRACT INFECTION | 2,092 |
| MULTIPLE SCLEROSIS RELAPSE | 1,733 |
| PAIN | 1,716 |
| FATIGUE | 1,665 |
| PNEUMONIA | 1,640 |
| ASTHENIA | 1,475 |
| NAUSEA | 1,455 |
| VOMITING | 1,287 |
| SOMNOLENCE | 1,242 |
| DYSPNOEA | 1,224 |
| PYREXIA | 1,203 |
| HEADACHE | 1,186 |
| TOXICITY TO VARIOUS AGENTS | 1,131 |
| OVERDOSE | 1,121 |
| COMA | 1,115 |
| GAIT DISTURBANCE | 1,073 |
| CONFUSIONAL STATE | 1,028 |
How to read baclofen FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 83,476 voluntary reports linked to baclofen (Lioresal, Gablofen), 2003-2025. Death is listed on 6,213 (7.4%). Hospitalization appears on 27,326 (32.7%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with baclofen
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 83,781 FAERS cases (Δ 305 heavier vs baclofen); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 82,622 FAERS cases (Δ 854 lighter vs baclofen); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 84,725 FAERS cases (Δ 1,249 heavier vs baclofen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 82,165 FAERS cases (Δ 1,311 lighter vs baclofen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.7 pp vs baclofen's DEATH-HEAVY): CASELOAD · HOSP-MID.
baclofen stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.