AVONEX FDA MedWatch Voluntary U.S. Reports Summary
These tables and charts are created from 1,234 U.S. reports for AVONEX (INTERFERON BETA-1A) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events
reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent
official drug label.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS AVONEX Report.
Top Adverse Events Reported with AVONEX (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 URINARY TRACT INFECTION 75 2 FALL 74 3 INFLUENZA LIKE ILLNESS 66 4 THERAPY INTERRUPTED 56 5 DRUG INEFFECTIVE 45 6 FATIGUE 42 7 DEATH 41 8 HEADACHE 38 9 MULTIPLE SCLEROSIS RELAPSE 35 10 PAIN 35 11 PNEUMONIA 35 12 DIZZINESS 31 13 CHILLS 27 14 SEIZURE 27 15 NAUSEA 26 16 DEPRESSION 25 17 FEVER 25 18 LACK OF STRENGTH AND ENERGY (ASTHENIA) 23 19 NUMBNESS 23 20 INJECTION SITE PAIN 23 21 GAIT DISTURBANCE 22 22 PAIN IN EXTREMITY 22 23 RASH 22 24 STROKE 21 25 MULTIPLE SCLEROSIS 21
AVONEX Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 239 | 972 | 1,234 |
| Medwatch Reporter Type | Count |
| Consumer | 96 |
| Physician | 64 |
| Pharmacist | 314 |
| Other Health Professional | 635 |
| Top Indications | |
| Multiple sclerosis | |
| Relapsing multiple sclerosis | |
| Product used for unknown indication | |
| Relapsing-remitting multiple sclerosis | |
| Maternal exposure timing unspecified | |
Type of Outcome Reported
Serious: 784
Not Serious: 450
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 1234
Concomitant Drugs: 197
Note: A single MedWatch report can list more than one drug. This summary includes AVONEX identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
AVONEX (INTERFERON BETA 1A) Rx Drug:
FDA 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
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. 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.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA 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 about this report.
