Drug Safety Information for XOLAIR (Omalizumab)

Safety-related Labeling Changes for XOLAIR (OMALIZUMAB) Biological Drug: FDA Link

Adverse Drug Reactions for XOLAIR* (Omalizumab)

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 XOLAIR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Asthma2340
2Dyspnoea1530
3Cough890
4Anaphylactic reaction868
5Wheezing815
6Headache748
7Fatigue728
8Malaise648
9Pneumonia578
10Hypersensitivity572
11Chest discomfort555
12Dizziness528
13Urticaria518
14Drug ineffective507
15Nasopharyngitis495
16Pruritus468
17Arthralgia427
18Death418
19Nausea400
20Blood pressure increased387

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

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

Reason # of FDA Reports
1Asthma34982
2Product used for unknown indication6318
3Hypersensitivity553
4Rhinitis allergic469
5Urticaria464
6Urticaria chronic195
7Off label use186
8Rhinitis157
9Chronic obstructive pulmonary disease131
10Dyspnoea126

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


Types of Adverse Events for XOLAIR

Total Reports Filed with FDA: 47788


Number of FDA Adverse Event Reports by Patient Age for XOLAIR

Total Reports Filed with FDA: 47788*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Omalizumab (Xolair)

Charts are based on 47788 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 XOLAIR Reviews and Review Summary .

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.

Visit   DrugInformer.com more on XOLAIR's side effects.