FDA Adverse Events Reports (FAERS) Summary for AVONEX

These tables and charts are based on 145,438 total reports for AVONEX (INTERFERON BETA-1A) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 144,204 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,234 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 1,234 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch AVONEX summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with AVONEX (reported in FAERS Database)

 Side Effect# of FDA Reports
1MULTIPLE SCLEROSIS RELAPSE11945
2INFLUENZA LIKE ILLNESS10420
3FATIGUE8646
4FALL8139
5MULTIPLE SCLEROSIS7704
6GAIT DISTURBANCE7248
7MEMORY IMPAIRMENT7169
8HEADACHE6031
9PAIN5878
10LACK OF STRENGTH AND ENERGY (ASTHENIA)4782
11MALAISE4060
12DRUG INEFFECTIVE4005
13NUMBNESS3953
14INJECTION SITE PAIN3927
15PAIN IN EXTREMITY3906
16BALANCE DISORDER3822
17DEATH3798
18FEVER3696
19DEPRESSION3635
20ANXIETY3601

Latest Known Outcomes for Reactions Reported for AVONEX

Latest Known Outcome for Reported ReactionsNumber of Cases
1Unknown Outcome41414
2Patient has not recovered/symtoms have not resolved38691
3Patient recovered37587
4Patient died3629
5Patient has recovered but has consequent health issues2319
6Patient is recovering/symptoms resolving468

Yearly FDA Adverse Event Reports (Table)

YearNumber of Reports
19971
19982
19991
20003
20013
20025
200310
20042771
20054915
20063417
20073157
20084354
20094548
201013657
201112084
201214034
201320138
201414658
20158493
20168729
20176578
20185739
20194508
20203884
20212673
20222270
20231929
20241339
20251095
2026443

Reports by Patient Age Group (Table)

Age GroupNumber of Reports
0-10377
11-20773
21-305102
31-4012879
41-5023044
51-6025862
61-7014943
71-803629
81-90316
91+12

Based on 86937 reports that included a patient age.

AVONEX Total Reports

 Male    Female    Unknown    Total  
 28073    115243    2122    145,438  

Top Countries Reporting

 Country  Number of Reports
United States  81994
Germany  1983
Brazil  1517
Canada  655
United Kingdom  606
France  311
Japan  246
Netherlands  235
Portugal  214
10 India  195

Outcomes for Reports

Serious: 66060
Not Serious: 79356
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications      
Multiple sclerosis
Relapsing multiple sclerosis
Product used for unknown indication
Relapsing-remitting multiple sclerosis
Maternal exposure timing unspecified

Top Companies Reporting

   BIOGEN

Safety-Related FDA Updates

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


Have experience (good or bad) with AVONEX? Rate AVONEX at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for AVONEX reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.