DEFLAZACORT

N/A

Manufactured by PTC Therapeutics, Inc.

10,344 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DEFLAZACORT

DEFLAZACORT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by PTC Therapeutics, Inc.. The most commonly reported adverse reactions for DEFLAZACORT include WEIGHT INCREASED, OFF LABEL USE, FALL, NO ADVERSE EVENT, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEFLAZACORT.

Top Adverse Reactions

WEIGHT INCREASED526 reports
OFF LABEL USE395 reports
FALL297 reports
NO ADVERSE EVENT243 reports
VOMITING243 reports
PRODUCT DOSE OMISSION ISSUE242 reports
PAIN226 reports
PYREXIA217 reports
HEADACHE211 reports
DRUG INEFFECTIVE208 reports
MALAISE208 reports
INFLUENZA207 reports
WEIGHT DECREASED186 reports
NASOPHARYNGITIS180 reports
ARTHRALGIA179 reports
DIARRHOEA178 reports
FATIGUE165 reports
RASH165 reports
ASTHENIA164 reports
PNEUMONIA161 reports
NAUSEA159 reports
PAIN IN EXTREMITY156 reports
ERYTHEMA138 reports
ABDOMINAL PAIN UPPER137 reports
ABNORMAL BEHAVIOUR137 reports
COUGH136 reports
RHEUMATOID ARTHRITIS124 reports
DYSPNOEA123 reports
DEATH115 reports
PRODUCT DOSE OMISSION105 reports
INTENTIONAL DOSE OMISSION100 reports
ANGER98 reports
INCREASED APPETITE97 reports
DIZZINESS94 reports
BACK PAIN93 reports
DECREASED APPETITE90 reports
GAIT DISTURBANCE87 reports
OSTEOPOROSIS87 reports
PRURITUS86 reports
INSOMNIA85 reports
SWELLING FACE85 reports
CUSHINGOID84 reports
INFLAMMATION84 reports
PERIPHERAL SWELLING84 reports
ABDOMINAL DISCOMFORT81 reports
ANXIETY79 reports
URINARY TRACT INFECTION79 reports
ABDOMINAL PAIN77 reports
CONSTIPATION77 reports
AGGRESSION75 reports
HYPERSENSITIVITY75 reports
DRUG INTERACTION74 reports
URTICARIA74 reports
GASTROENTERITIS VIRAL72 reports
FEMUR FRACTURE71 reports
CATARACT69 reports
DEPRESSION69 reports
IRRITABILITY69 reports
SWELLING66 reports
INFECTION65 reports
MOOD ALTERED65 reports
MUSCULAR WEAKNESS62 reports
EMOTIONAL DISORDER61 reports
POLLAKIURIA61 reports
CONDITION AGGRAVATED60 reports
MOBILITY DECREASED60 reports
HYPERTENSION58 reports
CHEST PAIN55 reports
COVID 1955 reports
CRYING55 reports
GAIT INABILITY54 reports
HYPOTENSION54 reports
NEPHROLITHIASIS54 reports
OEDEMA PERIPHERAL54 reports
PRODUCT USE IN UNAPPROVED INDICATION54 reports
SYNCOPE53 reports
ANGIOEDEMA52 reports
DRUG HYPERSENSITIVITY52 reports
MYALGIA52 reports
ANAEMIA51 reports
TACHYCARDIA50 reports
JOINT SWELLING48 reports
RHABDOMYOLYSIS47 reports
SINUSITIS46 reports
ARTHRITIS45 reports
SKIN DISCOLOURATION45 reports
ARTHROPATHY44 reports
GASTROINTESTINAL DISORDER44 reports
LOWER LIMB FRACTURE44 reports
RENAL IMPAIRMENT44 reports
DRUG DOSE OMISSION43 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS42 reports
MOOD SWINGS42 reports
HEART RATE INCREASED41 reports
LOCALISED INFECTION41 reports
MUSCLE SPASMS41 reports
DYSPHAGIA40 reports
OROPHARYNGEAL PAIN40 reports
DEHYDRATION39 reports
SKIN ULCER39 reports

Report Outcomes

Out of 6,203 classified reports for DEFLAZACORT:

Serious 50.1%Non-Serious 49.9%

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

Male2,841 (65.9%)
Female1,461 (33.9%)
Unknown9 (0.2%)

Reports by Age

Age 11103 reports
Age 8100 reports
Age 13100 reports
Age 1299 reports
Age 1588 reports
Age 1681 reports
Age 1080 reports
Age 1477 reports
Age 975 reports
Age 1867 reports
Age 6062 reports
Age 759 reports
Age 6857 reports
Age 1753 reports
Age 2249 reports
Age 644 reports
Age 2043 reports
Age 2343 reports
Age 6540 reports
Age 6339 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 DEFLAZACORT?

This profile reflects 10,344 FDA FAERS reports that mention DEFLAZACORT. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEFLAZACORT?

Frequently reported terms in FAERS include WEIGHT INCREASED, OFF LABEL USE, FALL, NO ADVERSE EVENT, VOMITING, PRODUCT DOSE OMISSION ISSUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DEFLAZACORT?

Labeling and FAERS entries often list PTC Therapeutics, Inc. in connection with DEFLAZACORT. 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.