Drug Safety Information for AVONEX (Interferon beta 1a)

Safety-related Labeling Changes for AVONEX (INTERFERON BETA 1A) Rx Drug: FDA Link

Adverse Drug Reactions for AVONEX* (Interferon beta 1a)

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 AVONEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Multiple sclerosis relapse10825
2Influenza like illness*9817
3Fatigue9019
4Fall7974
5Gait disturbance6789
6Multiple sclerosis6678
7Headache*6392
8Pain*5793
9Asthenia5164
10Memory impairment5083
11Injection site pain4710
12Hypoaesthesia*4361
13Depression*4186
14Pain in extremity4038
15Pyrexia3918
16Urinary tract infection3765
17Balance disorder3694
18Malaise3534
19Nausea3510
20Anxiety3417

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

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

Reason # of FDA Reports
1Multiple sclerosis*394659
2Product used for unknown indication27682
3Relapsing-remitting multiple sclerosis16821
4Secondary progressive multiple sclerosis888
5Off label use414
6Primary progressive multiple sclerosis364
7Maternal exposure during pregnancy307
8Progressive multiple sclerosis231
9Maternal exposure timing unspecified156
10Multiple sclerosis relapse85

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


Types of Adverse Events for AVONEX

Total Reports Filed with FDA: 456483


Number of FDA Adverse Event Reports by Patient Age for AVONEX

Total Reports Filed with FDA: 456483*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Interferon beta 1a (Avonex, Rebif)

Charts are based on 456483 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 AVONEX 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.