tazarotene Side Effects
Also known as: Tazorac
Analysis of 1,132 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,132
Death-Related
15
1.3% of reports
Hospitalizations
159
14.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 15 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 6 |
| COVID-19 | 4 |
| ILLNESS | 4 |
| IMMUNOSUPPRESSION | 4 |
| LUNG DISORDER | 4 |
| PNEUMOCYSTIS JIROVECII INFECTION | 4 |
| SKIN INFECTION | 4 |
| DRUG EXPOSURE DURING PREGNANCY | 2 |
| OFF LABEL USE | 2 |
| PREGNANCY | 2 |
| ABORTION SPONTANEOUS | 1 |
| ACUTE RESPIRATORY FAILURE | 1 |
| AFFECT LABILITY | 1 |
| AMMONIA INCREASED | 1 |
| ANENCEPHALY | 1 |
| ASTHENIA | 1 |
| BLOOD CHOLESTEROL INCREASED | 1 |
| BLOOD TRIGLYCERIDES INCREASED | 1 |
| CAESAREAN SECTION | 1 |
| CHRONIC HEPATIC FAILURE | 1 |
Reactions in Hospitalization Reports
Top reactions in 159 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DIARRHOEA | 14 |
| PAIN | 14 |
| ANXIETY | 12 |
| INFLAMMATORY BOWEL DISEASE | 11 |
| PULMONARY EMBOLISM | 11 |
| EMOTIONAL DISTRESS | 10 |
| INJURY | 10 |
| HEADACHE | 9 |
| HYPERTRANSAMINASAEMIA | 9 |
| COLITIS ULCERATIVE | 8 |
| DYSPNOEA | 8 |
| FATIGUE | 8 |
| OFF LABEL USE | 8 |
| PNEUMONIA | 8 |
| VOMITING | 8 |
| ABDOMINAL PAIN | 7 |
| ANAL HAEMORRHAGE | 7 |
| DEEP VEIN THROMBOSIS | 7 |
| DRUG EXPOSURE DURING PREGNANCY | 7 |
| DRY SKIN | 7 |
Nearby — Related Medications
What the FAERS Data Reveals About tazarotene Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,132 voluntary reports linked to tazarotene and its brand equivalents (Tazorac), spanning 2004 through 2025. Of those, 15 (1.3%) listed death as an outcome and 159 (14.0%) 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, 69% were female and 31% male; age distribution skews toward 18-44, with 227 reports in that bracket. The single most reported reaction is drug ineffective with 102 submissions, followed by erythema and off label use.
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.
Read our methodology — how this data is sourced, computed, and verified.