CEFEPIME

N/A

Manufactured by Apotex Corp.

25,295 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CEFEPIME

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

Top Adverse Reactions

DRUG INEFFECTIVE1,388 reports
ACUTE KIDNEY INJURY1,130 reports
OFF LABEL USE1,039 reports
PYREXIA876 reports
PNEUMONIA657 reports
FEBRILE NEUTROPENIA654 reports
HYPOTENSION540 reports
SEPSIS539 reports
ENCEPHALOPATHY488 reports
THROMBOCYTOPENIA469 reports
NEUTROPENIA467 reports
SEPTIC SHOCK451 reports
RESPIRATORY FAILURE426 reports
CONDITION AGGRAVATED415 reports
DIARRHOEA412 reports
CONFUSIONAL STATE365 reports
NAUSEA349 reports
DYSPNOEA347 reports
RENAL FAILURE337 reports
ANAEMIA331 reports
RASH319 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS314 reports
DRUG INTERACTION313 reports
DEATH302 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME301 reports
PRODUCT USE IN UNAPPROVED INDICATION295 reports
PANCYTOPENIA284 reports
VOMITING279 reports
CYTOKINE RELEASE SYNDROME266 reports
NEUROTOXICITY260 reports
HYPOXIA259 reports
MENTAL STATUS CHANGES253 reports
TACHYCARDIA227 reports
BLOOD CREATININE INCREASED225 reports
ASTHENIA223 reports
CARDIAC ARREST221 reports
ABDOMINAL PAIN217 reports
FATIGUE212 reports
PLATELET COUNT DECREASED212 reports
RENAL IMPAIRMENT207 reports
RENAL FAILURE ACUTE204 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION199 reports
PLEURAL EFFUSION197 reports
TOXICITY TO VARIOUS AGENTS191 reports
COUGH184 reports
ASPARTATE AMINOTRANSFERASE INCREASED182 reports
ALANINE AMINOTRANSFERASE INCREASED178 reports
ATRIAL FIBRILLATION178 reports
WHITE BLOOD CELL COUNT DECREASED177 reports
DRUG RESISTANCE172 reports
ACUTE RESPIRATORY DISTRESS SYNDROME169 reports
HEADACHE168 reports
PAIN165 reports
LEUKOPENIA157 reports
TUBULOINTERSTITIAL NEPHRITIS155 reports
ACUTE RESPIRATORY FAILURE153 reports
CLOSTRIDIUM DIFFICILE COLITIS152 reports
STAPHYLOCOCCAL INFECTION152 reports
URINARY TRACT INFECTION152 reports
HYPERTENSION151 reports
HAEMOGLOBIN DECREASED150 reports
MYOCLONUS144 reports
INFECTION143 reports
STATUS EPILEPTICUS142 reports
DISEASE PROGRESSION141 reports
RENAL TUBULAR NECROSIS139 reports
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS138 reports
EOSINOPHILIA138 reports
RESPIRATORY DISTRESS136 reports
DECREASED APPETITE134 reports
BACTERAEMIA133 reports
CLOSTRIDIUM DIFFICILE INFECTION132 reports
COVID 19132 reports
NEUTROPHIL COUNT DECREASED131 reports
ERYTHEMA130 reports
FALL129 reports
PRURITUS129 reports
CHILLS128 reports
METABOLIC ACIDOSIS127 reports
SHOCK125 reports
CELLULITIS121 reports
RASH MACULO PAPULAR121 reports
SEIZURE119 reports
GASTROINTESTINAL HAEMORRHAGE118 reports
HYPOKALAEMIA118 reports
PATHOGEN RESISTANCE117 reports
CANDIDA INFECTION116 reports
CONSTIPATION116 reports
PSEUDOMONAS INFECTION116 reports
GENERAL PHYSICAL HEALTH DETERIORATION115 reports
LACTIC ACIDOSIS115 reports
SOMNOLENCE115 reports
DEHYDRATION113 reports
LEUKOCYTOSIS111 reports
NEPHROPATHY TOXIC111 reports
HYPERKALAEMIA110 reports
TREATMENT FAILURE110 reports
DELIRIUM109 reports
DRUG HYPERSENSITIVITY109 reports
MULTI ORGAN FAILURE109 reports

Report Outcomes

Out of 13,671 classified reports for CEFEPIME:

Serious 94.0%Non-Serious 6.0%

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

Male6,985 (55.4%)
Female5,586 (44.3%)
Unknown27 (0.2%)

Reports by Age

Age 59315 reports
Age 67295 reports
Age 65289 reports
Age 69278 reports
Age 63271 reports
Age 75271 reports
Age 62267 reports
Age 58263 reports
Age 64259 reports
Age 66255 reports
Age 60252 reports
Age 70247 reports
Age 71244 reports
Age 74241 reports
Age 72236 reports
Age 61234 reports
Age 76232 reports
Age 73230 reports
Age 68225 reports
Age 57223 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 CEFEPIME?

This profile reflects 25,295 FDA FAERS reports that mention CEFEPIME. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CEFEPIME?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, ACUTE KIDNEY INJURY, OFF LABEL USE, PYREXIA, PNEUMONIA, FEBRILE NEUTROPENIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CEFEPIME?

Labeling and FAERS entries often list Apotex Corp. in connection with CEFEPIME. 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.