Drug Safety Information for KEFZOL (Cefazolin sodium)

Safety-related Labeling Changes for CEFAZOLIN AND DEXTROSE (CEFAZOLIN SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for CEFAZOLIN IN PLASTIC CONTAINER (CEFAZOLIN SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for KEFZOL* (Cefazolin 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 KEFZOL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain913
2Renal failure831
3Injury795
4Anxiety767
5Unevaluable event679
6Fear601
7Emotional distress566
8Renal injury522
9Renal impairment474
10Anhedonia467
11Stress431
12Multi-organ failure388
13Death383
14Hypotension328
15Depression311
16Pyrexia308
17Renal failure acute256
18Nausea251
19Dyspnoea227
20Anaemia191

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

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

Reason # of FDA Reports
1Product used for unknown indication4261
2Infection prophylaxis912
3Prophylaxis874
4Antibiotic prophylaxis775
5Infection284
6Preoperative care136
7Surgery122
8Antibiotic therapy119
9Pneumonia118
10Cellulitis118

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


Types of Adverse Events for KEFZOL

Total Reports Filed with FDA: 37918


Number of FDA Adverse Event Reports by Patient Age for KEFZOL

Total Reports Filed with FDA: 37918*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cefazolin sodium (Cefazolina, Ancef, Cefamedin, Cefamezine, Cefazolin sodium, Cefazolin, Kefzol)

Charts are based on 37918 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 KEFZOL 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.