CEFUROXIME AXETIL

N/A

Manufactured by American Health Packaging

13,186 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CEFUROXIME AXETIL

CEFUROXIME AXETIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by American Health Packaging. The most commonly reported adverse reactions for CEFUROXIME AXETIL include DIARRHOEA, FATIGUE, ANXIETY, DYSPNOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CEFUROXIME AXETIL.

Top Adverse Reactions

DIARRHOEA329 reports
FATIGUE319 reports
ANXIETY313 reports
DYSPNOEA274 reports
DRUG INEFFECTIVE247 reports
VOMITING245 reports
DIZZINESS242 reports
ABDOMINAL PAIN234 reports
RASH229 reports
HEADACHE228 reports
MALAISE222 reports
PRURITUS213 reports
HYPERSENSITIVITY203 reports
ABDOMINAL PAIN UPPER197 reports
NAUSEA195 reports
PNEUMONIA195 reports
ASTHMA187 reports
URTICARIA187 reports
PAIN IN EXTREMITY184 reports
BRONCHITIS181 reports
DEPRESSION178 reports
CONDITION AGGRAVATED177 reports
HYPERHIDROSIS175 reports
WHEEZING175 reports
OFF LABEL USE174 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE169 reports
FIBROMYALGIA167 reports
OBSTRUCTIVE AIRWAYS DISORDER160 reports
FEELING ABNORMAL155 reports
MIGRAINE154 reports
CYSTITIS151 reports
AGITATION149 reports
DRUG INTOLERANCE146 reports
HALLUCINATION145 reports
FLUID RETENTION143 reports
LYMPHOEDEMA139 reports
PYREXIA139 reports
FULL BLOOD COUNT ABNORMAL131 reports
DRUG HYPERSENSITIVITY126 reports
ANAPHYLACTIC REACTION120 reports
COUGH120 reports
HAEMOPTYSIS118 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES116 reports
PAIN116 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION114 reports
LUNG DISORDER113 reports
SWELLING FACE113 reports
VISION BLURRED110 reports
PULMONARY FIBROSIS108 reports
ARTHRALGIA107 reports
CHRONIC KIDNEY DISEASE107 reports
HYPOTHYROIDISM107 reports
PULMONARY ALVEOLAR HAEMORRHAGE107 reports
TINNITUS107 reports
DYSPHONIA106 reports
PULMONARY EMBOLISM106 reports
PULMONARY VASCULITIS106 reports
ANGIOEDEMA105 reports
MYOCARDIAL INFARCTION105 reports
NEURITIS104 reports
NEUROLOGICAL SYMPTOM104 reports
SWOLLEN TONGUE103 reports
VASCULITIS102 reports
RESPIRATORY SYMPTOM101 reports
PRODUCTIVE COUGH99 reports
SLEEP APNOEA SYNDROME99 reports
MYALGIA98 reports
HYPOXIA96 reports
STOMATITIS96 reports
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS95 reports
OESOPHAGEAL PAIN95 reports
PRODUCT USE IN UNAPPROVED INDICATION95 reports
CONSTIPATION92 reports
OESOPHAGEAL SPASM92 reports
DEATH91 reports
DRUG INTERACTION90 reports
ACUTE KIDNEY INJURY86 reports
THROMBOSIS85 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION84 reports
ARTERIOSCLEROSIS CORONARY ARTERY83 reports
CONJUNCTIVITIS ALLERGIC83 reports
NORMOCHROMIC NORMOCYTIC ANAEMIA79 reports
ARTERIOSCLEROSIS78 reports
RENAL FAILURE78 reports
NODULE77 reports
DUST ALLERGY74 reports
MITE ALLERGY74 reports
MYCOTIC ALLERGY73 reports
ASTHENIA71 reports
BACK PAIN71 reports
SPIROMETRY ABNORMAL71 reports
ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE69 reports
ERYTHEMA68 reports
FORCED EXPIRATORY VOLUME DECREASED67 reports
ABDOMINAL DISTENSION64 reports
TOTAL LUNG CAPACITY ABNORMAL64 reports
HYPERTENSION63 reports
URINARY TRACT INFECTION63 reports
CAPILLARITIS61 reports
ANAPHYLACTIC SHOCK60 reports

Report Outcomes

Out of 3,307 classified reports for CEFUROXIME AXETIL:

Serious 76.6%Non-Serious 23.4%

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

Female1,877 (63.7%)
Male1,067 (36.2%)
Unknown4 (0.1%)

Reports by Age

Age 65116 reports
Age 5396 reports
Age 6096 reports
Age 4194 reports
Age 6157 reports
Age 7250 reports
Age 7350 reports
Age 5448 reports
Age 5647 reports
Age 6245 reports
Age 5943 reports
Age 6943 reports
Age 4840 reports
Age 6440 reports
Age 7040 reports
Age 6739 reports
Age 5138 reports
Age 6338 reports
Age 7638 reports
Age 5235 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 AXETIL?

This profile reflects 13,186 FDA FAERS reports that mention CEFUROXIME AXETIL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CEFUROXIME AXETIL?

Frequently reported terms in FAERS include DIARRHOEA, FATIGUE, ANXIETY, DYSPNOEA, DRUG INEFFECTIVE, VOMITING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CEFUROXIME AXETIL?

Labeling and FAERS entries often list American Health Packaging in connection with CEFUROXIME AXETIL. 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.