Drug Safety Information for CEFOTAN (Cefotetan disodium)

Safety-related Labeling Changes for CEFOTAN (CEFOTETAN DISODIUM) Rx Drug: FDA Link

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

Adverse Drug Reactions for CEFOTAN* (Cefotetan disodium)

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 CEFOTAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Haemolytic anaemia18
2Nausea9
3Pain7
4Haemoglobin decreased7
5Hypertension7
6Dyspnoea7
7Weight decreased6
8Asthenia6
9Dizziness6
10Injury6
11Paraesthesia5
12Tremor5
13Thrombocytopenia5
14Anxiety5
15Anaemia5
16Renal failure5
17Pyrexia4
18Hypoaesthesia4
19Fatigue4
20Chest discomfort4

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

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

Reason # of FDA Reports
1Prophylaxis59
2Amniotic cavity infection13
3Skin ulcer13
4Preoperative care10
5Device related infection7
6Bile duct cancer6
7Perirectal abscess5
8Product used for unknown indication5
9Infected skin ulcer4
10Caesarean section4

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


Types of Adverse Events for CEFOTAN

Total Reports Filed with FDA: 738


Number of FDA Adverse Event Reports by Patient Age for CEFOTAN

Total Reports Filed with FDA: 738*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cefotetan disodium (Cefotetan disodium, Cefotan, Apacef, Cefotetan, Apatef)

Charts are based on 738 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 CEFOTAN 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.