FLUOCINONIDE

N/A

Manufactured by Bausch Health US, LLC

11,702 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FLUOCINONIDE

FLUOCINONIDE 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 FLUOCINONIDE include DRUG INEFFECTIVE, PSORIASIS, RASH, PRURITUS, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUOCINONIDE.

Top Adverse Reactions

DRUG INEFFECTIVE745 reports
PSORIASIS544 reports
RASH441 reports
PRURITUS406 reports
FATIGUE281 reports
DIARRHOEA280 reports
NAUSEA277 reports
PAIN271 reports
OFF LABEL USE265 reports
HEADACHE254 reports
ARTHRALGIA209 reports
PRODUCT USE IN UNAPPROVED INDICATION207 reports
DERMATITIS ATOPIC173 reports
PRODUCT DOSE OMISSION ISSUE173 reports
ERYTHEMA169 reports
DYSPNOEA168 reports
DIZZINESS167 reports
CHRONIC KIDNEY DISEASE161 reports
SKIN EXFOLIATION160 reports
CONDITION AGGRAVATED159 reports
DEATH128 reports
ANXIETY127 reports
PNEUMONIA125 reports
DRY SKIN123 reports
FALL123 reports
PAIN IN EXTREMITY121 reports
VOMITING120 reports
ASTHENIA119 reports
COUGH119 reports
RENAL FAILURE118 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE117 reports
TREATMENT FAILURE116 reports
ACUTE KIDNEY INJURY114 reports
DEPRESSION113 reports
MALAISE109 reports
DISCOMFORT108 reports
HYPERTENSION108 reports
ALOPECIA107 reports
ECZEMA107 reports
PSORIATIC ARTHROPATHY106 reports
BACK PAIN102 reports
INSOMNIA100 reports
WEIGHT DECREASED96 reports
PYREXIA93 reports
SLEEP DISORDER91 reports
INJECTION SITE PAIN90 reports
NASOPHARYNGITIS90 reports
URTICARIA83 reports
CONSTIPATION81 reports
ABDOMINAL DISCOMFORT80 reports
COVID 1980 reports
URINARY TRACT INFECTION80 reports
ARTHRITIS77 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION77 reports
GAIT DISTURBANCE76 reports
INFECTION73 reports
DRUG HYPERSENSITIVITY72 reports
PERIPHERAL SWELLING72 reports
ABDOMINAL PAIN71 reports
CHEST PAIN71 reports
SINUSITIS70 reports
FEELING ABNORMAL69 reports
HYPERSENSITIVITY69 reports
PRODUCT USE ISSUE68 reports
GASTROOESOPHAGEAL REFLUX DISEASE67 reports
ABDOMINAL PAIN UPPER65 reports
WEIGHT INCREASED65 reports
ANAEMIA61 reports
ILLNESS61 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION61 reports
DRY EYE60 reports
RASH PRURITIC60 reports
SKIN LESION60 reports
BLOOD PRESSURE INCREASED59 reports
DECREASED APPETITE59 reports
HYPOTENSION57 reports
MUSCLE SPASMS57 reports
SKIN PLAQUE56 reports
STRESS56 reports
ASTHMA54 reports
END STAGE RENAL DISEASE54 reports
JOINT SWELLING54 reports
PRODUCT DOSE OMISSION52 reports
VISION BLURRED52 reports
EMOTIONAL DISTRESS51 reports
MYALGIA51 reports
MUSCULAR WEAKNESS50 reports
SOMNOLENCE50 reports
OEDEMA PERIPHERAL49 reports
PARAESTHESIA49 reports
HYPOAESTHESIA48 reports
BLOOD GLUCOSE INCREASED47 reports
DEHYDRATION47 reports
MIGRAINE47 reports
OROPHARYNGEAL PAIN47 reports
MEMORY IMPAIRMENT46 reports
PAPULE46 reports
BRONCHITIS45 reports
CONTUSION45 reports
EYE IRRITATION45 reports

Report Outcomes

Out of 5,458 classified reports for FLUOCINONIDE:

Serious 43.6%Non-Serious 56.4%

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

Female3,064 (60.0%)
Male2,027 (39.7%)
Unknown16 (0.3%)

Reports by Age

Age 6493 reports
Age 5985 reports
Age 7185 reports
Age 6580 reports
Age 7075 reports
Age 6274 reports
Age 5673 reports
Age 6772 reports
Age 5470 reports
Age 5769 reports
Age 6369 reports
Age 6668 reports
Age 5367 reports
Age 6067 reports
Age 5866 reports
Age 6166 reports
Age 6866 reports
Age 6966 reports
Age 7263 reports
Age 7559 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 FLUOCINONIDE?

This profile reflects 11,702 FDA FAERS reports that mention FLUOCINONIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FLUOCINONIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PSORIASIS, RASH, PRURITUS, FATIGUE, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FLUOCINONIDE?

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