Drug Safety Information for ALLEGRA (Fexofenadine hydrochloride)

Safety-related Labeling Changes for ALLEGRA HIVES (FEXOFENADINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Adverse Drug Reactions for ALLEGRA* (Fexofenadine hydrochloride)

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
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective3508
2Nausea1642
3Dyspnoea1490
4Headache*1411
5Dizziness*1256
6Fatigue1220
7Pain1131
8Diarrhoea1020
9Insomnia*926
10Rash876
11Anxiety*854
12Pruritus847
13Vomiting827
14Arthralgia760
15Depression*751
16Cough748
17Malaise703
18Chest pain697
19Asthenia694
20Hypertension688

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

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

Reason # of FDA Reports
1Hypersensitivity*12318
2Product used for unknown indication11001
3Seasonal allergy*4053
4Multiple allergies3281
5Rhinitis allergic*1185
6Pruritus916
7Urticaria*784
8Premedication469
9Asthma*426
10Prophylaxis415

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


Types of Adverse Events for ALLEGRA

Total Reports Filed with FDA: 122970


Number of FDA Adverse Event Reports by Patient Age for ALLEGRA

Total Reports Filed with FDA: 122970*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fexofenadine hydrochloride (Fexofenadine, Aller ease, Allegra hives, Care one aller ease, Dg health aller ease, Equaline aller ease, Fexo fenadine, Leader aller ease, Wal fex allergy, Shoprite aller ease, Wal-fex, Allegra allergy, Fexofenadine hcl, Allegra)

Charts are based on 122970 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 ALLEGRA 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.