Drug Safety Information for CEFTIN (Cefuroxime axetil)

Safety-related Labeling Changes for CEFTIN (CEFUROXIME AXETIL) Brand name discontinued; available as generic: FDA Link

Adverse Drug Reactions for CEFTIN* (Cefuroxime axetil)

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 CEFTIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*330
2Dyspnoea317
3Diarrhoea*301
4Vomiting295
5Pyrexia294
6Nausea*270
7Anxiety255
8Pneumonia237
9Renal failure226
10Hypotension215
11Injury212
12Rash207
13Drug ineffective201
14Drug hypersensitivity197
15Asthenia176
16Pruritus175
17Fatigue*175
18Drug interaction166
19Headache165
20Renal failure acute164

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

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

Reason # of FDA Reports
1Product used for unknown indication2693
2Sinusitis*702
3Urinary tract infection*625
4Bronchitis*530
5Pneumonia457
6Antibiotic prophylaxis425
7Prophylaxis397
8Infection324
9Upper respiratory tract infection*317
10Pharyngitis208

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


Types of Adverse Events for CEFTIN

Total Reports Filed with FDA: 30507


Number of FDA Adverse Event Reports by Patient Age for CEFTIN

Total Reports Filed with FDA: 30507*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cefuroxime axetil (Zinnat, Cefuroxime axetil, Ceftin)

Charts are based on 30507 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 CEFTIN 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.