BETAMETHASONE VALERATE

N/A

Manufactured by Alembic Pharmaceuticals Inc.

18,273 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BETAMETHASONE VALERATE

BETAMETHASONE VALERATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. The most commonly reported adverse reactions for BETAMETHASONE VALERATE include DRUG INEFFECTIVE, MACULAR DEGENERATION, PAIN, OFF LABEL USE, MALAISE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BETAMETHASONE VALERATE.

Top Adverse Reactions

DRUG INEFFECTIVE1,002 reports
MACULAR DEGENERATION626 reports
PAIN567 reports
OFF LABEL USE450 reports
MALAISE414 reports
PYREXIA408 reports
NAUSEA398 reports
WEIGHT DECREASED390 reports
HEADACHE389 reports
PRURITUS322 reports
RASH298 reports
ERYTHEMA293 reports
ABDOMINAL PAIN287 reports
VOMITING283 reports
DYSPNOEA281 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE248 reports
DYSPEPSIA244 reports
ABDOMINAL PAIN UPPER242 reports
DIARRHOEA236 reports
INFUSION RELATED REACTION232 reports
FATIGUE231 reports
PSORIASIS224 reports
RECTAL HAEMORRHAGE216 reports
CHRONIC SINUSITIS211 reports
MIGRAINE211 reports
PARAESTHESIA ORAL206 reports
CONSTIPATION204 reports
PARAESTHESIA204 reports
HAEMATOCHEZIA202 reports
ANAEMIA194 reports
HYPOAESTHESIA187 reports
PERIPHERAL SWELLING185 reports
PROCEDURAL PAIN182 reports
ORAL CANDIDIASIS180 reports
COLITIS ULCERATIVE177 reports
FREQUENT BOWEL MOVEMENTS176 reports
MEMORY IMPAIRMENT176 reports
DRUG INTOLERANCE175 reports
COLITIS174 reports
ARTHRALGIA172 reports
GASTROOESOPHAGEAL REFLUX DISEASE169 reports
FEMALE GENITAL TRACT FISTULA165 reports
CONTUSION163 reports
VAGINAL DISCHARGE163 reports
INSOMNIA162 reports
RADICULOPATHY162 reports
VAGINAL FLATULENCE162 reports
EPILEPSY161 reports
PROCTITIS161 reports
TASTE DISORDER155 reports
BLEPHAROSPASM152 reports
NASOPHARYNGITIS148 reports
PAIN IN EXTREMITY146 reports
COUGH144 reports
DIZZINESS144 reports
WHEEZING142 reports
PRODUCT USE IN UNAPPROVED INDICATION141 reports
DEPRESSED MOOD136 reports
FALL131 reports
CHEST PAIN128 reports
ASTHMA123 reports
CONDITION AGGRAVATED121 reports
JOINT SWELLING118 reports
CHEST DISCOMFORT117 reports
ABDOMINAL DISCOMFORT116 reports
PNEUMONIA115 reports
URTICARIA113 reports
HYPERTENSION110 reports
ASTHENIA109 reports
SLEEP DISORDER109 reports
BLISTER108 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION107 reports
UPPER RESPIRATORY TRACT INFECTION106 reports
STRESS103 reports
LOWER RESPIRATORY TRACT INFECTION101 reports
ANXIETY99 reports
INFECTION97 reports
INFLUENZA95 reports
SKIN EXFOLIATION92 reports
BACK PAIN89 reports
INJURY89 reports
MUSCLE SPASMS89 reports
NASAL CONGESTION89 reports
DEPRESSION88 reports
HYPERSENSITIVITY88 reports
WEIGHT INCREASED85 reports
MYALGIA84 reports
ALOPECIA80 reports
ANGINA PECTORIS79 reports
DISCOMFORT79 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION79 reports
OEDEMA PERIPHERAL79 reports
SYNOVITIS78 reports
PRODUCTIVE COUGH77 reports
DRUG HYPERSENSITIVITY76 reports
GAIT INABILITY76 reports
MEDICATION ERROR70 reports
MOBILITY DECREASED70 reports
RHINORRHOEA70 reports
DECREASED APPETITE68 reports

Report Outcomes

Out of 4,279 classified reports for BETAMETHASONE VALERATE:

Serious 88.9%Non-Serious 11.1%

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

Female2,583 (67.2%)
Male1,259 (32.7%)
Unknown4 (0.1%)

Reports by Age

Age 65155 reports
Age 43145 reports
Age 71135 reports
Age 61103 reports
Age 78100 reports
Age 7387 reports
Age 7482 reports
Age 6675 reports
Age 6975 reports
Age 7569 reports
Age 7668 reports
Age 6866 reports
Age 6765 reports
Age 8063 reports
Age 4862 reports
Age 7261 reports
Age 6258 reports
Age 5057 reports
Age 5456 reports
Age 5853 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 BETAMETHASONE VALERATE?

This profile reflects 18,273 FDA FAERS reports that mention BETAMETHASONE VALERATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BETAMETHASONE VALERATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, MACULAR DEGENERATION, PAIN, OFF LABEL USE, MALAISE, PYREXIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BETAMETHASONE VALERATE?

Labeling and FAERS entries often list Alembic Pharmaceuticals Inc. in connection with BETAMETHASONE VALERATE. 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.