CEFEPIME HYDROCHLORIDE

N/A

Manufactured by Sagent Pharmaceuticals

28,358 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CEFEPIME HYDROCHLORIDE

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

Top Adverse Reactions

DRUG INEFFECTIVE1,484 reports
ACUTE KIDNEY INJURY1,228 reports
OFF LABEL USE1,115 reports
PYREXIA1,049 reports
FEBRILE NEUTROPENIA815 reports
PNEUMONIA786 reports
SEPSIS591 reports
HYPOTENSION576 reports
ENCEPHALOPATHY544 reports
NEUTROPENIA531 reports
THROMBOCYTOPENIA525 reports
SEPTIC SHOCK493 reports
DIARRHOEA475 reports
RESPIRATORY FAILURE447 reports
CONDITION AGGRAVATED440 reports
CONFUSIONAL STATE411 reports
ANAEMIA396 reports
DYSPNOEA385 reports
NAUSEA384 reports
RENAL FAILURE383 reports
RASH381 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS370 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME338 reports
DRUG INTERACTION334 reports
DEATH332 reports
PRODUCT USE IN UNAPPROVED INDICATION312 reports
PANCYTOPENIA309 reports
VOMITING308 reports
NEUROTOXICITY298 reports
CYTOKINE RELEASE SYNDROME294 reports
PLATELET COUNT DECREASED287 reports
HYPOXIA274 reports
MENTAL STATUS CHANGES273 reports
BLOOD CREATININE INCREASED254 reports
PLEURAL EFFUSION242 reports
TACHYCARDIA242 reports
RENAL IMPAIRMENT241 reports
ABDOMINAL PAIN235 reports
ASTHENIA235 reports
FATIGUE234 reports
WHITE BLOOD CELL COUNT DECREASED234 reports
CARDIAC ARREST228 reports
RENAL FAILURE ACUTE217 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION210 reports
TOXICITY TO VARIOUS AGENTS208 reports
ASPARTATE AMINOTRANSFERASE INCREASED205 reports
COUGH204 reports
ALANINE AMINOTRANSFERASE INCREASED202 reports
NEUTROPHIL COUNT DECREASED200 reports
ATRIAL FIBRILLATION196 reports
PAIN184 reports
DRUG RESISTANCE183 reports
INFECTION181 reports
ACUTE RESPIRATORY DISTRESS SYNDROME179 reports
URINARY TRACT INFECTION179 reports
TUBULOINTERSTITIAL NEPHRITIS177 reports
HAEMOGLOBIN DECREASED176 reports
HEADACHE176 reports
LEUKOPENIA174 reports
CLOSTRIDIUM DIFFICILE COLITIS170 reports
STATUS EPILEPTICUS169 reports
HYPERTENSION166 reports
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS163 reports
ACUTE RESPIRATORY FAILURE163 reports
DECREASED APPETITE160 reports
MYOCLONUS157 reports
PRURITUS157 reports
STAPHYLOCOCCAL INFECTION156 reports
BACTERAEMIA155 reports
COVID 19153 reports
DISEASE PROGRESSION150 reports
RENAL TUBULAR NECROSIS150 reports
EOSINOPHILIA148 reports
ERYTHEMA147 reports
RESPIRATORY DISTRESS146 reports
HYPOKALAEMIA143 reports
CONSTIPATION141 reports
DRUG HYPERSENSITIVITY140 reports
RASH MACULO PAPULAR139 reports
SEIZURE139 reports
CLOSTRIDIUM DIFFICILE INFECTION138 reports
CELLULITIS137 reports
CHILLS137 reports
FALL136 reports
GENERAL PHYSICAL HEALTH DETERIORATION133 reports
DRUG INDUCED LIVER INJURY132 reports
DELIRIUM131 reports
METABOLIC ACIDOSIS131 reports
SHOCK131 reports
GASTROINTESTINAL HAEMORRHAGE130 reports
SOMNOLENCE128 reports
DISSEMINATED INTRAVASCULAR COAGULATION127 reports
PSEUDOMONAS INFECTION127 reports
OVERDOSE125 reports
UNRESPONSIVE TO STIMULI125 reports
CANDIDA INFECTION124 reports
LEUKOCYTOSIS123 reports
PATHOGEN RESISTANCE123 reports
BACK PAIN122 reports
LACTIC ACIDOSIS122 reports

Report Outcomes

Out of 15,315 classified reports for CEFEPIME HYDROCHLORIDE:

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

Male7,877 (55.7%)
Female6,235 (44.1%)
Unknown28 (0.2%)

Reports by Age

Age 59342 reports
Age 67331 reports
Age 75320 reports
Age 65315 reports
Age 69315 reports
Age 63305 reports
Age 62303 reports
Age 66298 reports
Age 60294 reports
Age 70294 reports
Age 58285 reports
Age 64282 reports
Age 71282 reports
Age 74276 reports
Age 72273 reports
Age 73269 reports
Age 61267 reports
Age 68265 reports
Age 76264 reports
Age 57237 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 HYDROCHLORIDE?

This profile reflects 28,358 FDA FAERS reports that mention CEFEPIME HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CEFEPIME HYDROCHLORIDE?

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

Who manufactures CEFEPIME HYDROCHLORIDE?

Labeling and FAERS entries often list Sagent Pharmaceuticals in connection with CEFEPIME 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.