MID-VOLUME · SEX-BALANCED
dolutegravir Side Effects
dolutegravir (also sold as Tivicay) sits MID-VOLUME #333 of 524 by FAERS report count. Lead signal: SEX-BALANCED - 36% of sex-coded reports are female (2,600 F / 4,713 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 8,756
- FAERS reports
FDA Adverse Event Reporting System extract for dolutegravir. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
dolutegravir reporting skew - 36% of sex-coded reports are female (2,600 F / 4,713 M). Volume band MID-VOLUME #333 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for dolutegravir (Tivicay) (8,756 reports). Signature SEX-BALANCED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2010–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
PAIN leads 1,425 of 8,756 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (2,345 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (865 reports, 9.9%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 390 |
| PAIN | 149 |
| FOETAL DEATH | 141 |
| FATIGUE | 130 |
| PYREXIA | 130 |
| THROMBOCYTOPENIA | 126 |
| HEPATIC ENZYME INCREASED | 125 |
| OVERDOSE | 116 |
| EXPOSURE DURING PREGNANCY | 115 |
| RHEUMATOID ARTHRITIS | 114 |
| HEADACHE | 113 |
| PSORIASIS | 113 |
| UPPER RESPIRATORY TRACT INFECTION | 112 |
| CONSTIPATION | 111 |
| HYPERHIDROSIS | 111 |
| HYPERTENSION | 111 |
| IMMUNODEFICIENCY | 111 |
Reactions in Hospitalization Reports
Hospitalization mid-share (1,908, 21.8%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PAIN | 307 |
| EMOTIONAL DISTRESS | 276 |
| ANXIETY | 273 |
| ANHEDONIA | 244 |
| CHRONIC KIDNEY DISEASE | 220 |
| RENAL FAILURE | 213 |
| ACUTE KIDNEY INJURY | 190 |
| HOSPITALISATION | 155 |
| FATIGUE | 147 |
| END STAGE RENAL DISEASE | 121 |
| DEPRESSION | 108 |
| ECONOMIC PROBLEM | 108 |
| PYREXIA | 100 |
| NAUSEA | 98 |
| RENAL IMPAIRMENT | 95 |
| ASTHENIA | 90 |
| OSTEOPOROSIS | 85 |
| PNEUMONIA | 85 |
| ANAEMIA | 83 |
| DYSPNOEA | 83 |
How to read dolutegravir FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 8,756 voluntary reports linked to dolutegravir (Tivicay), 2010-2025. Death is listed on 865 (9.9%). Hospitalization appears on 1,908 (21.8%). Top co-reported indication: Hiv Infection.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 36% of sex-coded reports are female (2,600 F / 4,713 M).
Read with dolutegravir
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 8,788 FAERS cases (Δ 32 heavier vs dolutegravir); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 8,574 FAERS cases (Δ 182 lighter vs dolutegravir); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 8,979 FAERS cases (Δ 223 heavier vs dolutegravir); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 8,530 FAERS cases (Δ 226 lighter vs dolutegravir); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.2 pp vs dolutegravir's DEATH-HEAVY): CASELOAD · HOSP-MID.
dolutegravir stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.