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) Latest Known Outcomes for Reactions Reported for AVONEX
Based on 86937 reports that included a patient age.
Side Effect # of FDA Reports 1 MULTIPLE SCLEROSIS RELAPSE 11945 2 INFLUENZA LIKE ILLNESS 10420 3 FATIGUE 8646 4 FALL 8139 5 MULTIPLE SCLEROSIS 7704 6 GAIT DISTURBANCE 7248 7 MEMORY IMPAIRMENT 7169 8 HEADACHE 6031 9 PAIN 5878 10 LACK OF STRENGTH AND ENERGY (ASTHENIA) 4782 11 MALAISE 4060 12 DRUG INEFFECTIVE 4005 13 NUMBNESS 3953 14 INJECTION SITE PAIN 3927 15 PAIN IN EXTREMITY 3906 16 BALANCE DISORDER 3822 17 DEATH 3798 18 FEVER 3696 19 DEPRESSION 3635 20 ANXIETY 3601 Latest Known Outcome for Reported Reactions Number of Cases 1 Unknown Outcome 41414 2 Patient has not recovered/symtoms have not resolved 38691 3 Patient recovered 37587 4 Patient died 3629 5 Patient has recovered but has consequent health issues 2319 6 Patient is recovering/symptoms resolving 468 Yearly FDA Adverse Event Reports (Table)
Year Number of Reports 1997 1 1998 2 1999 1 2000 3 2001 3 2002 5 2003 10 2004 2771 2005 4915 2006 3417 2007 3157 2008 4354 2009 4548 2010 13657 2011 12084 2012 14034 2013 20138 2014 14658 2015 8493 2016 8729 2017 6578 2018 5739 2019 4508 2020 3884 2021 2673 2022 2270 2023 1929 2024 1339 2025 1095 2026 443 Reports by Patient Age Group (Table)
Age Group Number of Reports 0-10 377 11-20 773 21-30 5102 31-40 12879 41-50 23044 51-60 25862 61-70 14943 71-80 3629 81-90 316 91+ 12
AVONEX Total Reports
| Male | Female | Unknown | Total |
|---|---|---|---|
| 28073 | 115243 | 2122 | 145,438 |
Top Countries Reporting
| Country | Number of Reports | |
|---|---|---|
| 1 | United States | 81994 |
| 2 | Germany | 1983 |
| 3 | Brazil | 1517 |
| 4 | Canada | 655 |
| 5 | United Kingdom | 606 |
| 6 | France | 311 |
| 7 | Japan | 246 |
| 8 | Netherlands | 235 |
| 9 | 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 | |
AVONEX (INTERFERON BETA 1A) Rx Drug: For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the
MedWatch voluntary reporting form.
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.
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.
Safety-Related FDA Updates
Safety-related Labeling Changes
Have experience (good or bad) with AVONEX? Rate AVONEX at Ask a Patient.
Notes
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.
