Drug Safety Information for SPECTRACEF (Cefditoren pivoxil)

Adverse Drug Reactions for SPECTRACEF* (Cefditoren pivoxil)

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 SPECTRACEF
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea*118
2Rash48
3Pyrexia*43
4Clostridium colitis42
5Drug ineffective41
6Nausea*40
7Off label use33
8Abdominal pain29
9Urticaria*25
10Vomiting25
11Clostridial infection24
12Liver disorder20
13Dyspnoea20
14Alanine aminotransferase increased18
15Aspartate aminotransferase increased17
16Malaise17
17Dyspepsia17
18Convulsion16
19Hepatic function abnormal15
20Pruritus14

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

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

Reason # of FDA Reports
1Bronchitis*194
2Sinusitis94
3Pharyngitis86
4Product used for unknown indication84
5Infection prophylaxis79
6Upper respiratory tract inflammation75
7Pneumonia60
8Otitis media60
9Pyrexia52
10Skin infection49

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


Types of Adverse Events for SPECTRACEF

Total Reports Filed with FDA: 2024


Number of FDA Adverse Event Reports by Patient Age for SPECTRACEF

Total Reports Filed with FDA: 2024*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cefditoren pivoxil (Spectracef, Cefditoren pivoxil)

Charts are based on 2024 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 SPECTRACEF 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.