AMPYRA: 3,956 Adverse Event Reports & Safety Profile
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3,956
Total FAERS Reports
63 (1.6%)
Deaths Reported
208
Hospitalizations
3,956
As Primary/Secondary Suspect
3
Life-Threatening
62
Disabilities
First Report: 1986 · Latest Report: 20140526
What Are the Most Common AMPYRA Side Effects?
#1 Most Reported
Drug ineffective
711 reports (18.0%)
#2 Most Reported
Gait disturbance
518 reports (13.1%)
#3 Most Reported
Dizziness
354 reports (8.9%)
All AMPYRA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 711 | 18.0% | 2 | 16 |
| Gait disturbance | 518 | 13.1% | 4 | 21 |
| Dizziness | 354 | 9.0% | 0 | 6 |
| Insomnia | 313 | 7.9% | 0 | 3 |
| Balance disorder | 262 | 6.6% | 1 | 10 |
| Headache | 247 | 6.2% | 1 | 8 |
| Nausea | 233 | 5.9% | 0 | 7 |
| Fall | 208 | 5.3% | 3 | 31 |
| Fatigue | 185 | 4.7% | 4 | 5 |
| Asthenia | 179 | 4.5% | 2 | 18 |
| Inappropriate schedule of drug administration | 178 | 4.5% | 3 | 9 |
| Urinary tract infection | 166 | 4.2% | 5 | 30 |
| Drug dose omission | 162 | 4.1% | 0 | 14 |
| Multiple sclerosis relapse | 159 | 4.0% | 3 | 49 |
| Back pain | 145 | 3.7% | 1 | 13 |
| Muscular weakness | 136 | 3.4% | 2 | 18 |
| Paraesthesia | 119 | 3.0% | 3 | 7 |
| Constipation | 117 | 3.0% | 0 | 5 |
| Malaise | 108 | 2.7% | 1 | 1 |
| Adverse drug reaction | 96 | 2.4% | 0 | 2 |
Who Reports AMPYRA Side Effects? Age & Gender Data
Average age: 55.4 years. Most reports from: US. View detailed demographics →
Is AMPYRA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2007 | 2 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2010 | 54 | 2 | 4 |
| 2011 | 67 | 3 | 9 |
| 2012 | 303 | 2 | 18 |
| 2013 | 1,763 | 23 | 99 |
| 2014 | 97 | 9 | 27 |
What Is AMPYRA Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 1,872 |
| Gait disturbance | 1,453 |
| Multiple sclerosis | 646 |
| Balance disorder | 40 |
| Muscular weakness | 16 |
| Asthenia | 15 |
| Fatigue | 15 |
| Ataxia | 11 |
| Relapsing-remitting multiple sclerosis | 9 |
| Muscle spasticity | 7 |
AMPYRA vs Alternatives: Which Is Safer?
AMPYRA vs AMRUBICIN
AMPYRA vs AMSACRINE
AMPYRA vs ANAGRELIDE
AMPYRA vs ANAKINRA
AMPYRA vs ANAMORELIN
AMPYRA vs ANASTROZOLE
AMPYRA vs ANDEXANET ALFA
AMPYRA vs ANDROGEL
AMPYRA vs ANETHOLTRITHION
AMPYRA vs ANGIOTENSIN II
Official FDA Label for AMPYRA
Official prescribing information from the FDA-approved drug label.