TAZAROTENE

N/A

Manufactured by Almirall, LLC

2,077 FDA adverse event reports analyzed

Last updated: 2026-04-15

About TAZAROTENE

TAZAROTENE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Almirall, LLC. The most commonly reported adverse reactions for TAZAROTENE include DRUG INEFFECTIVE, ERYTHEMA, OFF LABEL USE, SKIN EXFOLIATION, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TAZAROTENE.

Top Adverse Reactions

DRUG INEFFECTIVE102 reports
ERYTHEMA82 reports
OFF LABEL USE74 reports
SKIN EXFOLIATION74 reports
PAIN64 reports
PRURITUS62 reports
RASH62 reports
HEADACHE55 reports
APPLICATION SITE ERYTHEMA45 reports
ACNE42 reports
PSORIASIS40 reports
APPLICATION SITE PAIN38 reports
DRY SKIN38 reports
DIARRHOEA32 reports
FATIGUE32 reports
NAUSEA32 reports
PREGNANCY32 reports
BURNING SENSATION31 reports
SKIN IRRITATION30 reports
ARTHRALGIA28 reports
HYPERSENSITIVITY28 reports
DRUG EXPOSURE DURING PREGNANCY25 reports
DYSPNOEA25 reports
SKIN BURNING SENSATION25 reports
ANXIETY23 reports
APPLICATION SITE EXFOLIATION23 reports
URTICARIA23 reports
VOMITING23 reports
CONDITION AGGRAVATED22 reports
APPLICATION SITE DISCOLOURATION20 reports
DEPRESSION20 reports
PRODUCT USE IN UNAPPROVED INDICATION20 reports
ABDOMINAL PAIN19 reports
COUGH17 reports
THERAPEUTIC RESPONSE DECREASED17 reports
TREATMENT FAILURE17 reports
ALOPECIA16 reports
EMOTIONAL DISTRESS16 reports
PNEUMONIA16 reports
PRODUCT DOSE OMISSION ISSUE16 reports
DIZZINESS15 reports
FALL15 reports
INJURY15 reports
APPLICATION SITE DRYNESS14 reports
INFLAMMATORY BOWEL DISEASE14 reports
PSORIATIC ARTHROPATHY14 reports
SOMNOLENCE14 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE14 reports
WEIGHT DECREASED14 reports
APPLICATION SITE IRRITATION13 reports
BACK PAIN13 reports
DRUG DOSE OMISSION13 reports
NASOPHARYNGITIS13 reports
PULMONARY EMBOLISM13 reports
SKIN DISCOLOURATION13 reports
ABDOMINAL PAIN UPPER12 reports
ABORTION SPONTANEOUS12 reports
DEEP VEIN THROMBOSIS12 reports
EYE SWELLING12 reports
ILLNESS12 reports
PAIN IN EXTREMITY12 reports
SWELLING FACE12 reports
APPLICATION SITE PRURITUS11 reports
ASTHENIA11 reports
BLISTER11 reports
BLOOD TRIGLYCERIDES INCREASED11 reports
COLITIS ULCERATIVE11 reports
HYPERHIDROSIS11 reports
INSOMNIA11 reports
PRODUCT QUALITY ISSUE11 reports
RASH ERYTHEMATOUS11 reports
SKIN DEPIGMENTATION11 reports
SKIN LESION11 reports
COVID 1910 reports
EYE PAIN10 reports
GAIT DISTURBANCE10 reports
HYPOTENSION10 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION10 reports
INJECTION SITE PAIN10 reports
MALAISE10 reports
PARAESTHESIA10 reports
PYREXIA10 reports
RASH MACULAR10 reports
SCAR10 reports
SINUSITIS10 reports
SKIN HYPERPIGMENTATION10 reports
UPPER RESPIRATORY TRACT INFECTION10 reports
WEIGHT INCREASED10 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS10 reports
APPLICATION SITE RASH9 reports
CHEST PAIN9 reports
CROHN^S DISEASE9 reports
DECREASED APPETITE9 reports
FEELING ABNORMAL9 reports
GENERAL PHYSICAL HEALTH DETERIORATION9 reports
HYPERTENSION9 reports
HYPERTRANSAMINASAEMIA9 reports
LIP DRY9 reports
OROPHARYNGEAL PAIN9 reports
SKIN INFECTION9 reports

Report Outcomes

Out of 1,132 classified reports for TAZAROTENE:

Serious 34.4%Non-Serious 65.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female681 (68.6%)
Male306 (30.8%)
Unknown6 (0.6%)

Reports by Age

Age 1623 reports
Age 1816 reports
Age 4416 reports
Age 4615 reports
Age 4715 reports
Age 5514 reports
Age 1513 reports
Age 1713 reports
Age 2313 reports
Age 5813 reports
Age 2012 reports
Age 5612 reports
Age 6312 reports
Age 2111 reports
Age 2511 reports
Age 3911 reports
Age 4211 reports
Age 5211 reports
Age 5411 reports
Age 1910 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with TAZAROTENE?

This profile reflects 2,077 FDA FAERS reports that mention TAZAROTENE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TAZAROTENE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, ERYTHEMA, OFF LABEL USE, SKIN EXFOLIATION, PAIN, PRURITUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TAZAROTENE?

Labeling and FAERS entries often list Almirall, LLC in connection with TAZAROTENE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.