HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE

N/A

Manufactured by Legacy Pharma USA Inc.

571 FDA adverse event reports analyzed

Last updated: 2026-04-15

About HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE

HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Legacy Pharma USA Inc.. The most commonly reported adverse reactions for HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE include DRUG INEFFECTIVE, RASH, FATIGUE, PRURITUS, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE21 reports
RASH17 reports
FATIGUE15 reports
PRURITUS15 reports
DYSPNOEA12 reports
HEADACHE12 reports
PAIN12 reports
DEATH11 reports
INSOMNIA11 reports
NAUSEA11 reports
URINARY TRACT INFECTION11 reports
ANXIETY10 reports
CHRONIC KIDNEY DISEASE10 reports
OFF LABEL USE10 reports
PSORIASIS10 reports
WEIGHT DECREASED9 reports
DIARRHOEA8 reports
DRY SKIN8 reports
ERYTHEMA8 reports
NEUROPATHY PERIPHERAL8 reports
ARTHRALGIA7 reports
CHEST DISCOMFORT7 reports
GASTROOESOPHAGEAL REFLUX DISEASE7 reports
SINUSITIS7 reports
ASTHENIA6 reports
CHEST PAIN6 reports
DIZZINESS6 reports
FALL6 reports
OROPHARYNGEAL PAIN6 reports
PRODUCT DOSE OMISSION ISSUE6 reports
RASH ERYTHEMATOUS6 reports
WEIGHT INCREASED6 reports
ABDOMINAL PAIN5 reports
ACUTE KIDNEY INJURY5 reports
ANAEMIA5 reports
APPLICATION SITE RASH5 reports
BURNING SENSATION5 reports
CONSTIPATION5 reports
DECREASED APPETITE5 reports
DEEP VEIN THROMBOSIS5 reports
DEPRESSION5 reports
DRY EYE5 reports
HYPERSENSITIVITY5 reports
MALAISE5 reports
MEMORY IMPAIRMENT5 reports
RENAL FAILURE ACUTE5 reports
SKIN BURNING SENSATION5 reports
VOMITING5 reports
ABDOMINAL DISCOMFORT4 reports
ABDOMINAL DISTENSION4 reports
ABDOMINAL PAIN UPPER4 reports
APPLICATION SITE ERYTHEMA4 reports
BLOOD CREATININE INCREASED4 reports
BRONCHITIS4 reports
CONDITION AGGRAVATED4 reports
CONFUSIONAL STATE4 reports
CONTUSION4 reports
CORONARY ARTERY DISEASE4 reports
COUGH4 reports
DISEASE PROGRESSION4 reports
EMOTIONAL DISTRESS4 reports
FEELING ABNORMAL4 reports
FLUSHING4 reports
HAEMOGLOBIN DECREASED4 reports
INFECTION4 reports
INJURY4 reports
IRRITABLE BOWEL SYNDROME4 reports
MENTAL STATUS CHANGES4 reports
MUSCULAR WEAKNESS4 reports
MYALGIA4 reports
MYOCARDIAL INFARCTION4 reports
OEDEMA PERIPHERAL4 reports
PNEUMONIA4 reports
PSORIATIC ARTHROPATHY4 reports
PULMONARY EMBOLISM4 reports
SLEEP APNOEA SYNDROME4 reports
SWELLING FACE4 reports
TREATMENT FAILURE4 reports
ACUTE RESPIRATORY FAILURE3 reports
ALOPECIA3 reports
AMNESIA3 reports
APPLICATION SITE PAIN3 reports
APPLICATION SITE PRURITUS3 reports
ASTHMA3 reports
BACK PAIN3 reports
BLOOD GLUCOSE INCREASED3 reports
CARDIAC ARREST3 reports
CARDIAC FAILURE CONGESTIVE3 reports
CELLULITIS3 reports
COLITIS3 reports
CROHN'S DISEASE3 reports
DEHYDRATION3 reports
DERMATITIS ATOPIC3 reports
DRUG DOSE OMISSION3 reports
DRUG HYPERSENSITIVITY3 reports
DYSPEPSIA3 reports
DYSPHONIA3 reports
EAR INFECTION3 reports
ECZEMA3 reports
FEELING HOT3 reports

Report Outcomes

Out of 207 classified reports for HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE:

Serious 58.0%Non-Serious 42.0%

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

Female126 (64.3%)
Male70 (35.7%)

Reports by Age

Age 716 reports
Age 736 reports
Age 625 reports
Age 765 reports
Age 845 reports
Age 534 reports
Age 614 reports
Age 674 reports
Age 744 reports
Age 63 reports
Age 593 reports
Age 653 reports
Age 663 reports
Age 693 reports
Age 703 reports
Age 793 reports
Age 803 reports
Age 242 reports
Age 322 reports
Age 332 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 HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE?

This profile reflects 571 FDA FAERS reports that mention HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE?

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

Who manufactures HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE?

Labeling and FAERS entries often list Legacy Pharma USA Inc. in connection with HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE. 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.