Drug Safety Information for OMNICEF (Cefdinir)

Adverse Drug Reactions for OMNICEF* (Cefdinir)

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 OMNICEF
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Diarrhoea*	247
2	Rash	172
3	Nausea*	157
4	Pain	151
5	Pyrexia	142
6	Vomiting*	141
7	Dyspnoea	138
8	Faeces discoloured	129
9	Anxiety*	114
10	Urticaria	113
11	Fatigue	104
12	Headache*	94
13	Dizziness*	92
14	Oedema peripheral	88
15	Arthralgia	88
16	Abdominal pain	86
17	Injury	85
18	Asthenia	77
19	Pain in extremity	76
20	Chest pain	76

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	966
2	Sinusitis*	643
3	Ear infection*	546
4	Bronchitis*	270
5	Otitis media	190
6	Pharyngitis*	135
7	Infection	127
8	Upper respiratory tract infection	120
9	Infection prophylaxis	115
10	Pharyngitis streptococcal	105

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

Types of Adverse Events for OMNICEF

Total Reports Filed with FDA: 13337

Number of FDA Adverse Event Reports by Patient Age for OMNICEF

Total Reports Filed with FDA: 13337*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cefdinir (Omnicef, Cefdinir)

Charts are based on 13337 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.

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.