CLOBETASOL PROPIONATE OINTMENT USP, 0.05%

N/A

Manufactured by Encube Ethicals, Inc.

18,702 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CLOBETASOL PROPIONATE OINTMENT USP, 0.05%

CLOBETASOL PROPIONATE OINTMENT USP, 0.05% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Encube Ethicals, Inc.. The most commonly reported adverse reactions for CLOBETASOL PROPIONATE OINTMENT USP, 0.05% include DRUG INEFFECTIVE, PRURITUS, OFF LABEL USE, RASH, PSORIASIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLOBETASOL PROPIONATE OINTMENT USP, 0.05%.

Top Adverse Reactions

DRUG INEFFECTIVE980 reports
PRURITUS770 reports
OFF LABEL USE632 reports
RASH569 reports
PSORIASIS517 reports
FATIGUE468 reports
PRODUCT USE IN UNAPPROVED INDICATION468 reports
HEADACHE446 reports
NAUSEA400 reports
DIARRHOEA393 reports
ARTHRALGIA381 reports
PAIN361 reports
SKIN EXFOLIATION331 reports
DRY SKIN322 reports
ERYTHEMA305 reports
CONDITION AGGRAVATED296 reports
DYSPNOEA283 reports
PRODUCT DOSE OMISSION ISSUE278 reports
DIZZINESS258 reports
INJECTION SITE PAIN258 reports
PAIN IN EXTREMITY258 reports
DERMATITIS ATOPIC249 reports
FALL235 reports
VOMITING220 reports
ECZEMA219 reports
PYREXIA213 reports
MALAISE210 reports
INSOMNIA208 reports
ASTHENIA198 reports
WEIGHT DECREASED190 reports
ANXIETY188 reports
DEPRESSION184 reports
BACK PAIN180 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION177 reports
ALOPECIA172 reports
COUGH166 reports
PNEUMONIA166 reports
PRODUCT USE ISSUE164 reports
PERIPHERAL SWELLING157 reports
SKIN FISSURES144 reports
DECREASED APPETITE142 reports
HYPERTENSION140 reports
URTICARIA138 reports
COVID 19137 reports
GAIT DISTURBANCE132 reports
MYALGIA131 reports
URINARY TRACT INFECTION129 reports
PSORIATIC ARTHROPATHY128 reports
MUSCLE SPASMS127 reports
HYPERSENSITIVITY126 reports
FEELING ABNORMAL125 reports
NASOPHARYNGITIS125 reports
WEIGHT INCREASED121 reports
BURNING SENSATION120 reports
DRUG HYPERSENSITIVITY115 reports
ABDOMINAL DISCOMFORT114 reports
NEUROPATHY PERIPHERAL112 reports
SKIN ATROPHY112 reports
DEATH111 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION111 reports
INFECTION108 reports
CONSTIPATION105 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE105 reports
HYPOAESTHESIA103 reports
INCORRECT DOSE ADMINISTERED103 reports
SINUSITIS103 reports
SKIN DISCOLOURATION103 reports
ABDOMINAL PAIN101 reports
ABDOMINAL PAIN UPPER100 reports
DRY EYE100 reports
CHEST PAIN99 reports
CONTUSION98 reports
BLOOD PRESSURE INCREASED97 reports
VISION BLURRED96 reports
SKIN HAEMORRHAGE95 reports
BLISTER94 reports
ILLNESS94 reports
OEDEMA PERIPHERAL94 reports
RASH PRURITIC94 reports
ANAEMIA93 reports
SKIN BURNING SENSATION90 reports
PARAESTHESIA89 reports
MYOCARDIAL INFARCTION86 reports
JOINT SWELLING85 reports
SYNCOPE85 reports
TREATMENT FAILURE83 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS81 reports
CELLULITIS80 reports
PRODUCT QUALITY ISSUE80 reports
INJECTION SITE ERYTHEMA79 reports
MUSCULAR WEAKNESS79 reports
UPPER RESPIRATORY TRACT INFECTION79 reports
ACCIDENTAL EXPOSURE TO PRODUCT78 reports
DYSURIA78 reports
STRESS78 reports
INFLUENZA77 reports
RENAL FAILURE76 reports
HYPERHIDROSIS75 reports
INJECTION SITE SWELLING75 reports
RASH ERYTHEMATOUS74 reports

Report Outcomes

Out of 9,432 classified reports for CLOBETASOL PROPIONATE OINTMENT USP, 0.05%:

Serious 48.0%Non-Serious 52.0%

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

Female5,380 (63.8%)
Male3,041 (36.1%)
Unknown10 (0.1%)

Reports by Age

Age 65178 reports
Age 63157 reports
Age 62156 reports
Age 58140 reports
Age 55138 reports
Age 67137 reports
Age 68136 reports
Age 64133 reports
Age 66132 reports
Age 69131 reports
Age 73131 reports
Age 72130 reports
Age 57129 reports
Age 54126 reports
Age 70123 reports
Age 61122 reports
Age 60121 reports
Age 71121 reports
Age 74120 reports
Age 76114 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 CLOBETASOL PROPIONATE OINTMENT USP, 0.05%?

This profile reflects 18,702 FDA FAERS reports that mention CLOBETASOL PROPIONATE OINTMENT USP, 0.05%. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CLOBETASOL PROPIONATE OINTMENT USP, 0.05%?

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

Who manufactures CLOBETASOL PROPIONATE OINTMENT USP, 0.05%?

Labeling and FAERS entries often list Encube Ethicals, Inc. in connection with CLOBETASOL PROPIONATE OINTMENT USP, 0.05%. 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.