TRETINOIN

N/A

Manufactured by Bausch Health US, LLC

22,211 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TRETINOIN

TRETINOIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US, LLC. The most commonly reported adverse reactions for TRETINOIN include OFF LABEL USE, DRUG INEFFECTIVE, PAIN, PRODUCT USE IN UNAPPROVED INDICATION, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRETINOIN.

Top Adverse Reactions

OFF LABEL USE897 reports
DRUG INEFFECTIVE788 reports
PAIN535 reports
PRODUCT USE IN UNAPPROVED INDICATION463 reports
VOMITING462 reports
NAUSEA423 reports
RASH387 reports
HEADACHE377 reports
DIARRHOEA361 reports
PARAESTHESIA356 reports
FATIGUE336 reports
ABDOMINAL PAIN UPPER334 reports
HYPOAESTHESIA326 reports
DRUG INTOLERANCE318 reports
GASTROOESOPHAGEAL REFLUX DISEASE306 reports
DEPRESSION305 reports
CONDITION AGGRAVATED296 reports
MATERNAL EXPOSURE DURING PREGNANCY292 reports
ARTHRALGIA288 reports
TASTE DISORDER288 reports
MEMORY IMPAIRMENT282 reports
EPILEPSY281 reports
DIZZINESS276 reports
PRURITUS273 reports
BLEPHAROSPASM263 reports
MIGRAINE262 reports
PNEUMONIA256 reports
ANXIETY251 reports
ALOPECIA242 reports
DRY SKIN241 reports
PRODUCT USE ISSUE239 reports
ASTHENIA238 reports
DYSPNOEA229 reports
ERYTHEMA228 reports
DRUG HYPERSENSITIVITY218 reports
PRODUCT QUALITY ISSUE216 reports
WEIGHT INCREASED215 reports
DIFFERENTIATION SYNDROME213 reports
ABDOMINAL DISCOMFORT210 reports
PYREXIA210 reports
URTICARIA205 reports
PAIN IN EXTREMITY201 reports
TREATMENT FAILURE201 reports
HYPERTENSION187 reports
NECK PAIN187 reports
RHEUMATOID ARTHRITIS185 reports
NASOPHARYNGITIS182 reports
MUSCLE SPASMS181 reports
SKIN EXFOLIATION180 reports
SWELLING176 reports
INJURY173 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE172 reports
ACNE170 reports
INTENTIONAL PRODUCT USE ISSUE170 reports
GENERAL PHYSICAL HEALTH DETERIORATION169 reports
OSTEOARTHRITIS169 reports
BLISTER168 reports
SLEEP DISORDER168 reports
PERIPHERAL SWELLING163 reports
INSOMNIA162 reports
WOUND161 reports
MUSCULAR WEAKNESS159 reports
PERICARDITIS159 reports
SYNOVITIS159 reports
DRY MOUTH158 reports
PSORIATIC ARTHROPATHY157 reports
THERAPEUTIC PRODUCT EFFECT DECREASED156 reports
STOMATITIS155 reports
JOINT SWELLING154 reports
CONFUSIONAL STATE153 reports
IRRITABLE BOWEL SYNDROME153 reports
PRODUCT DOSE OMISSION ISSUE149 reports
ARTHROPATHY148 reports
CONTRAINDICATED PRODUCT ADMINISTERED148 reports
INFLAMMATION145 reports
TYPE 2 DIABETES MELLITUS145 reports
BLOOD CHOLESTEROL INCREASED143 reports
SYSTEMIC LUPUS ERYTHEMATOSUS143 reports
NIGHT SWEATS142 reports
ABDOMINAL PAIN141 reports
MALAISE138 reports
LIP DRY137 reports
FIBROMYALGIA135 reports
RHEUMATIC FEVER135 reports
WEIGHT DECREASED135 reports
PEMPHIGUS134 reports
BACK INJURY132 reports
HYPERSENSITIVITY132 reports
INFUSION RELATED REACTION132 reports
ONYCHOMADESIS132 reports
HEPATIC ENZYME INCREASED131 reports
MUSCULOSKELETAL PAIN131 reports
WHEEZING131 reports
BREAST CANCER STAGE III129 reports
FOLLICULITIS129 reports
NEUTROPENIA129 reports
BURSITIS128 reports
FEBRILE NEUTROPENIA128 reports
THROMBOCYTOPENIA128 reports
GLOSSODYNIA127 reports

Report Outcomes

Out of 7,620 classified reports for TRETINOIN:

Serious 60.4%Non-Serious 39.6%

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

Female5,039 (75.9%)
Male1,560 (23.5%)
Unknown43 (0.6%)

Reports by Age

Age 43371 reports
Age 40131 reports
Age 34115 reports
Age 65103 reports
Age 1691 reports
Age 1988 reports
Age 5278 reports
Age 1577 reports
Age 1775 reports
Age 5375 reports
Age 3974 reports
Age 6874 reports
Age 2973 reports
Age 5973 reports
Age 6071 reports
Age 5569 reports
Age 4768 reports
Age 3367 reports
Age 3867 reports
Age 2366 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 TRETINOIN?

This profile reflects 22,211 FDA FAERS reports that mention TRETINOIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TRETINOIN?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, PAIN, PRODUCT USE IN UNAPPROVED INDICATION, VOMITING, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TRETINOIN?

Labeling and FAERS entries often list Bausch Health US, LLC in connection with TRETINOIN. 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.