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 | |
---|---|---|
1 | Multiple sclerosis relapse | 10825 |
2 | Influenza like illness* | 9817 |
3 | Fatigue | 9019 |
4 | Fall | 7974 |
5 | Gait disturbance | 6789 |
6 | Multiple sclerosis | 6678 |
7 | Headache* | 6392 |
8 | Pain* | 5793 |
9 | Asthenia | 5164 |
10 | Memory impairment | 5083 |
11 | Injection site pain | 4710 |
12 | Hypoaesthesia* | 4361 |
13 | Depression* | 4186 |
14 | Pain in extremity | 4038 |
15 | Pyrexia | 3918 |
16 | Urinary tract infection | 3765 |
17 | Balance disorder | 3694 |
18 | Malaise | 3534 |
19 | Nausea | 3510 |
20 | Anxiety | 3417 |
* 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 | |
---|---|---|
1 | Multiple sclerosis* | 394659 |
2 | Product used for unknown indication | 27682 |
3 | Relapsing-remitting multiple sclerosis | 16821 |
4 | Secondary progressive multiple sclerosis | 888 |
5 | Off label use | 414 |
6 | Primary progressive multiple sclerosis | 364 |
7 | Maternal exposure during pregnancy | 307 |
8 | Progressive multiple sclerosis | 231 |
9 | Maternal exposure timing unspecified | 156 |
10 | Multiple sclerosis relapse | 85 |
*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.