Drug side effects
dolutegravir Side Effects
The reactions most often reported to the FDA for dolutegravir (also sold as Tivicay), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 8,756
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2010 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 dolutegravir come from 8,756 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 8,756 reports to the FDA Adverse Event Reporting System (FAERS) for dolutegravir (Tivicay): 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
8,756
Reports Mentioning Death
865
9.9% of reports — not proof the medicine caused the death
Hospitalizations
1,908
21.8% of reports
Top Indication
Hiv Infection
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 865 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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
Top reactions in 1,908 reports where hospitalization was an outcome.
| 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 |
Nearby, Related Medications
What the FAERS Data Reveals About dolutegravir Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 8,756 voluntary reports linked to dolutegravir and its brand equivalents (Tivicay), spanning 2010 through 2025. Of those, 865 (9.9%) listed death as an outcome and 1,908 (21.8%) involved hospitalization. The most common indication reported alongside adverse events was Hiv Infection.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 35% were female and 64% male; age distribution skews toward 45-64, with 2,345 reports in that bracket. The single most reported reaction is pain with 1,425 submissions, followed by anxiety and emotional distress.
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to dolutegravir's 8,756.
Read our methodology - how this data is sourced, computed, and verified.