CEFUROXIME

N/A

Manufactured by Hikma Pharmaceuticals USA Inc.

25,003 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CEFUROXIME

CEFUROXIME is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hikma Pharmaceuticals USA Inc.. The most commonly reported adverse reactions for CEFUROXIME include DYSPNOEA, DRUG INEFFECTIVE, PNEUMONIA, PYREXIA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CEFUROXIME.

Top Adverse Reactions

DYSPNOEA738 reports
DRUG INEFFECTIVE663 reports
PNEUMONIA607 reports
PYREXIA591 reports
OFF LABEL USE585 reports
RENAL FAILURE580 reports
DIARRHOEA574 reports
CHRONIC KIDNEY DISEASE573 reports
ACUTE KIDNEY INJURY561 reports
ANXIETY445 reports
FATIGUE437 reports
CONDITION AGGRAVATED436 reports
NAUSEA433 reports
PAIN419 reports
RASH397 reports
VOMITING396 reports
HEADACHE377 reports
DRUG INTERACTION361 reports
DRUG HYPERSENSITIVITY336 reports
URINARY TRACT INFECTION321 reports
MALAISE317 reports
COUGH315 reports
DIZZINESS311 reports
DEATH307 reports
HYPOTENSION299 reports
ASTHENIA296 reports
ASTHMA294 reports
ANAPHYLACTIC REACTION293 reports
PAIN IN EXTREMITY292 reports
SEPSIS279 reports
ABDOMINAL PAIN264 reports
FOETAL EXPOSURE DURING PREGNANCY262 reports
WHEEZING258 reports
PRURITUS256 reports
HYPERSENSITIVITY239 reports
FALL238 reports
HAEMOPTYSIS234 reports
ANAEMIA232 reports
PULMONARY EMBOLISM229 reports
URTICARIA221 reports
ARTHRALGIA217 reports
PRODUCTIVE COUGH217 reports
LUNG DISORDER211 reports
PRODUCT USE IN UNAPPROVED INDICATION202 reports
OBSTRUCTIVE AIRWAYS DISORDER198 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE196 reports
RENAL INJURY193 reports
ERYTHEMA192 reports
RENAL IMPAIRMENT187 reports
DEPRESSION186 reports
HYPOTHYROIDISM186 reports
CONSTIPATION185 reports
WEIGHT DECREASED184 reports
VASCULITIS183 reports
BACK PAIN182 reports
INJURY182 reports
ANGIOEDEMA179 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS176 reports
PULMONARY FIBROSIS176 reports
EXPOSURE DURING PREGNANCY175 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES174 reports
HYPOXIA171 reports
BRONCHITIS168 reports
END STAGE RENAL DISEASE166 reports
PULMONARY ALVEOLAR HAEMORRHAGE166 reports
PULMONARY VASCULITIS166 reports
PREMATURE BABY164 reports
ABDOMINAL PAIN UPPER163 reports
NEUROLOGICAL SYMPTOM162 reports
NEURITIS161 reports
RESPIRATORY SYMPTOM160 reports
DECREASED APPETITE158 reports
SINUSITIS158 reports
ANAPHYLACTIC SHOCK156 reports
EMOTIONAL DISTRESS156 reports
OEDEMA PERIPHERAL156 reports
FULL BLOOD COUNT ABNORMAL154 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION153 reports
HYPERTENSION152 reports
THROMBOCYTOPENIA152 reports
CHEST PAIN150 reports
RASH MACULO PAPULAR150 reports
DEHYDRATION147 reports
TACHYCARDIA147 reports
MATERNAL EXPOSURE DURING PREGNANCY143 reports
MYALGIA143 reports
RESPIRATORY FAILURE142 reports
SWELLING FACE139 reports
THROMBOSIS139 reports
CHILLS136 reports
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS136 reports
GENERAL PHYSICAL HEALTH DETERIORATION134 reports
TOXICITY TO VARIOUS AGENTS134 reports
UNEVALUABLE EVENT133 reports
INFECTION132 reports
CLOSTRIDIUM DIFFICILE INFECTION128 reports
CARDIAC ARREST126 reports
TOXIC EPIDERMAL NECROLYSIS122 reports
SEPTIC SHOCK117 reports
ANHEDONIA116 reports

Report Outcomes

Out of 11,088 classified reports for CEFUROXIME:

Serious 90.1%Non-Serious 9.9%

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

Female5,857 (57.5%)
Male4,277 (42.0%)
Unknown53 (0.5%)

Reports by Age

Age 65324 reports
Age 60212 reports
Age 61212 reports
Age 64203 reports
Age 70195 reports
Age 62177 reports
Age 69174 reports
Age 75172 reports
Age 72169 reports
Age 66166 reports
Age 63161 reports
Age 74158 reports
Age 67157 reports
Age 71154 reports
Age 57153 reports
Age 68153 reports
Age 58152 reports
Age 37143 reports
Age 76143 reports
Age 77139 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 CEFUROXIME?

This profile reflects 25,003 FDA FAERS reports that mention CEFUROXIME. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CEFUROXIME?

Frequently reported terms in FAERS include DYSPNOEA, DRUG INEFFECTIVE, PNEUMONIA, PYREXIA, OFF LABEL USE, RENAL FAILURE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CEFUROXIME?

Labeling and FAERS entries often list Hikma Pharmaceuticals USA Inc. in connection with CEFUROXIME. 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.