Copaxoneglatiramer
According to the FDA label: Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).
53,194 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Copaxone in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Multiple Sclerosis Relapse 4,946 reports
A return or worsening of multiple sclerosis symptoms. It often appears in reports as part of the condition being treated.
Full definition in the glossary →Drug Ineffective 3,682 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Injection Site Pain 3,616 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Injection Site Reaction 3,106 reports
A general report of a reaction at the spot where a medication was injected, such as redness, swelling, or pain.
Full definition in the glossary →Fatigue 3,014 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Multiple Sclerosis 2,923 reports
A condition where the immune system affects the protective covering of nerves, which can disrupt movement and other functions. It often appears in reports as a condition being treated.
Full definition in the glossary →Dyspnoea 2,648 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Fall 2,388 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Gait Disturbance 1,973 reports
Difficulty walking normally, such as an unsteady or altered way of walking.
Full definition in the glossary →Pain 1,791 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Injection Site Erythema 1,788 reports
Redness of the skin at the spot where a medication was injected. Erythema means skin redness.
Full definition in the glossary →Nausea 1,739 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Dizziness 1,631 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Headache 1,596 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Hypoaesthesia 1,592 reports
Reduced sense of touch or numbness in part of the body. Also spelled hypoesthesia in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 40,584 |
| Male | 9,708 |
| Unknown | 330 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 323 |
| 18-34 | 3,904 |
| 35-49 | 8,341 |
| 50-64 | 9,453 |
| 65-74 | 2,497 |
| 75+ | 405 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Copaxone. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 26,884 |
| Other Serious | 19,203 |
| Hospitalization | 8,859 |
| Death | 1,212 |
| Disability | 541 |
| Life-Threatening | 502 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Copaxone. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 131 |
| 2005 | 275 |
| 2006 | 353 |
| 2007 | 397 |
| 2008 | 454 |
| 2009 | 782 |
| 2010 | 1,252 |
| 2011 | 1,520 |
| 2012 | 1,790 |
| 2013 | 2,068 |
| 2014 | 4,339 |
| 2015 | 5,908 |
| 2016 | 6,614 |
| 2017 | 5,841 |
| 2018 | 5,222 |
| 2019 | 4,228 |
| 2020 | 2,729 |
| 2021 | 2,494 |
| 2022 | 2,375 |
| 2023 | 1,779 |
| 2024 | 1,349 |
| 2025 | 1,071 |
| 2026 (partial) | 222 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Copaxone
In FDA adverse event reports that mention Copaxone, these medications appeared most often in the same report.
- Dalfampridine (4,954 reports)
- Ergocalciferol (3,886 reports)
- Baclofen (2,727 reports)
- Gabapentin (2,648 reports)
- Interferon Beta-1a (2,517 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026