Drug Safety Information for ALLEGRA-D (Fexofenadine; pseudoephedrine)

Adverse Drug Reactions for ALLEGRA-D* (Fexofenadine; pseudoephedrine)

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 ALLEGRA-D
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	298
2	Insomnia	144
3	Pain	97
4	Nausea	88
5	Headache	85
6	Dizziness	81
7	Dyspnoea	78
8	Feeling abnormal	73
9	Fatigue	72
10	Anxiety	60
11	Chest pain	51
12	Diarrhoea	50
13	Vomiting	50
14	Malaise	49
15	Abdominal pain	44
16	Injury	42
17	Depression	42
18	Somnolence	42
19	Deep vein thrombosis	42
20	Sinusitis	41

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

Top 10 Reasons for Taking ALLEGRA-D
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Hypersensitivity	864
2	Product used for unknown indication	750
3	Multiple allergies	379
4	Seasonal allergy	214
5	Nasal congestion	105
6	Rhinitis allergic	98
7	Rhinorrhoea	32
8	Sinusitis	30
9	Rhinitis	29
10	Sinus disorder	19

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

Types of Adverse Events for ALLEGRA-D

Total Reports Filed with FDA: 7151

Number of FDA Adverse Event Reports by Patient Age for ALLEGRA-D

Total Reports Filed with FDA: 7151*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fexofenadine; pseudoephedrine (Allegra-d)

Charts are based on 7151 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.