Drug Safety Information for XYZAL (Levocetirizine dihydrochloride)

Safety-related Labeling Changes for XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for XYZAL* (Levocetirizine dihydrochloride)

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 XYZAL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea222
2Nausea191
3Headache191
4Rash180
5Fatigue*180
6Pyrexia158
7Drug ineffective158
8Pruritus148
9Pain145
10Diarrhoea136
11Dizziness129
12Urticaria114
13Malaise113
14Vomiting112
15Anaemia106
16Somnolence*102
17Asthenia99
18Anxiety*97
19Arthralgia96
20Cough91

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

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

Reason # of FDA Reports
1Product used for unknown indication2157
2Hypersensitivity*1627
3Multiple allergies529
4Seasonal allergy*484
5Rhinitis allergic*434
6Pruritus389
7Urticaria*233
8Rhinitis*141
9Rash121
10Prophylaxis106

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


Types of Adverse Events for XYZAL

Total Reports Filed with FDA: 16198


Number of FDA Adverse Event Reports by Patient Age for XYZAL

Total Reports Filed with FDA: 16198*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Levocetirizine dihydrochloride (Levocetirizine, Xusal, Xyzal)

Charts are based on 16198 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 XYZAL 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.