Drug Safety Information for ZINACEF (Cefuroxime sodium)

Safety-related Labeling Changes for ZINACEF (CEFUROXIME SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for ZINACEF IN PLASTIC CONTAINER (CEFUROXIME SODIUM) Discontinued Drug: FDA Link

Safety-related Labeling Changes for CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER (CEFUROXIME SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for ZINACEF* (Cefuroxime sodium)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ZINACEF
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain166
2Renal failure161
3Anxiety158
4Injury155
5Unevaluable event138
6Fear132
7Emotional distress122
8Renal injury112
9Renal impairment99
10Anhedonia98
11Stress94
12Multi-organ failure92
13Death87
14Dyspnoea86
15Depression62
16Anaphylactic shock61
17Pyrexia59
18Renal failure acute54
19Hypotension52
20Rash49

* This side effect also appears in "Top 10 Side Effects of ZINACEF " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ZINACEF
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication642
2Prophylaxis282
3Pneumonia250
4Antibiotic prophylaxis151
5Infection124
6Infection prophylaxis118
7Urinary tract infection91
8Pyrexia74
9Antibiotic therapy61
10Cataract operation56

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ZINACEF

Total Reports Filed with FDA: 6584


Number of FDA Adverse Event Reports by Patient Age for ZINACEF

Total Reports Filed with FDA: 6584*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cefuroxime sodium (Cefuroxime sodium, Zinacef, Kefurox)

Charts are based on 6584 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ZINACEF Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.