KETOPROFEN

N/A

Manufactured by Allegis Pharmaceuticals, Inc.

36,564 FDA adverse event reports analyzed

Last updated: 2026-04-14

About KETOPROFEN

KETOPROFEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allegis Pharmaceuticals, Inc.. The most commonly reported adverse reactions for KETOPROFEN include HEADACHE, PAIN, FATIGUE, DRUG INEFFECTIVE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for KETOPROFEN.

Top Adverse Reactions

HEADACHE1,152 reports
PAIN1,075 reports
FATIGUE896 reports
DRUG INEFFECTIVE747 reports
NAUSEA745 reports
PYREXIA724 reports
OFF LABEL USE699 reports
INFUSION SITE PAIN673 reports
RHEUMATOID ARTHRITIS671 reports
HYPERSENSITIVITY667 reports
BACK PAIN660 reports
HYPERHIDROSIS656 reports
DIARRHOEA643 reports
ERYTHEMA639 reports
CONSTIPATION615 reports
DRUG HYPERSENSITIVITY614 reports
RASH607 reports
VOMITING602 reports
ASTHMA586 reports
HEPATIC ENZYME INCREASED578 reports
IMMUNODEFICIENCY552 reports
OVERDOSE551 reports
DYSPNOEA548 reports
FOOD ALLERGY535 reports
RASH ERYTHEMATOUS532 reports
UPPER RESPIRATORY TRACT INFECTION531 reports
HYPERTENSION520 reports
FLUID RETENTION513 reports
ACUTE KIDNEY INJURY501 reports
JOINT SWELLING492 reports
PRODUCT USE ISSUE481 reports
TEMPERATURE REGULATION DISORDER441 reports
EXPOSURE DURING PREGNANCY427 reports
BURSITIS426 reports
THROMBOCYTOPENIA422 reports
INFUSION SITE ERYTHEMA414 reports
COELIAC DISEASE413 reports
DRUG INTERACTION412 reports
INFUSION RELATED REACTION401 reports
INTENTIONAL PRODUCT MISUSE398 reports
ASTHENIA388 reports
ARTHRALGIA384 reports
CONTRAINDICATED PRODUCT ADMINISTERED375 reports
DIZZINESS371 reports
PRESCRIBED OVERDOSE361 reports
DRUG INTOLERANCE357 reports
MALAISE318 reports
INFECTION317 reports
PAIN IN EXTREMITY313 reports
HYPOTENSION304 reports
PSORIASIS304 reports
CONDITION AGGRAVATED297 reports
ANAEMIA289 reports
INFUSION SITE SWELLING285 reports
ABDOMINAL PAIN266 reports
PNEUMONIA266 reports
TOXICITY TO VARIOUS AGENTS262 reports
TREATMENT FAILURE262 reports
PRURITUS254 reports
WEIGHT DECREASED253 reports
FOETAL DEATH251 reports
DECREASED APPETITE249 reports
FALL243 reports
ANGIOEDEMA232 reports
ABDOMINAL PAIN UPPER215 reports
URTICARIA213 reports
SOMNOLENCE210 reports
COUGH206 reports
INFUSION SITE HAEMORRHAGE195 reports
SUICIDE ATTEMPT185 reports
PERIPHERAL SWELLING169 reports
CHEST PAIN168 reports
OEDEMA PERIPHERAL168 reports
DEPRESSION167 reports
INSOMNIA167 reports
CONFUSIONAL STATE165 reports
ANXIETY159 reports
INTENTIONAL OVERDOSE159 reports
PRODUCT USE IN UNAPPROVED INDICATION158 reports
RENAL FAILURE158 reports
MYALGIA154 reports
DRUG ABUSE149 reports
WEIGHT INCREASED146 reports
COMA145 reports
NASOPHARYNGITIS145 reports
TACHYCARDIA144 reports
LOSS OF CONSCIOUSNESS143 reports
THERAPY NON RESPONDER142 reports
RENAL FAILURE ACUTE140 reports
DEATH134 reports
ANAPHYLACTIC SHOCK133 reports
GENERAL PHYSICAL HEALTH DETERIORATION133 reports
FEELING ABNORMAL132 reports
GAIT DISTURBANCE132 reports
INFLAMMATION132 reports
INFUSION SITE INFECTION132 reports
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS129 reports
POISONING DELIBERATE128 reports
DEVICE DISLOCATION126 reports
INFUSION SITE DISCHARGE123 reports

Report Outcomes

Out of 12,276 classified reports for KETOPROFEN:

Serious 87.2%Non-Serious 12.8%

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

Female7,267 (63.1%)
Male4,238 (36.8%)
Unknown12 (0.1%)

Reports by Age

Age 58429 reports
Age 36226 reports
Age 69200 reports
Age 56191 reports
Age 63183 reports
Age 70183 reports
Age 64177 reports
Age 59175 reports
Age 61174 reports
Age 60172 reports
Age 68172 reports
Age 55163 reports
Age 66159 reports
Age 75159 reports
Age 65158 reports
Age 51157 reports
Age 49155 reports
Age 73152 reports
Age 52150 reports
Age 57150 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 KETOPROFEN?

This profile reflects 36,564 FDA FAERS reports that mention KETOPROFEN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for KETOPROFEN?

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

Who manufactures KETOPROFEN?

Labeling and FAERS entries often list Allegis Pharmaceuticals, Inc. in connection with KETOPROFEN. 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.