What the label lists and what reports show
Glatiramer side effects
Glatiramer's FDA label: “In controlled studies of COPAXONE 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) In a controlled study of COPAXONE 40 mg/mL, most common …” FAERS holds 62,165 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is multiple sclerosis relapse (5,368 reports).
- Generic listed
- Boxed warning
Check it at the source: the glatiramer FDA label on DailyMed (effective June 23, 2026, Teva Neuroscience, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of COPAXONE?COPAXONE may cause serious side effects, including: Immediate Post-Injection Reactions. Serious side effects may happen right after or within minutes after you inject COPAXONE at any time during your course of treatment. Some signs and symptoms may be the same as those of a serious allergic reaction (anaphylaxis). See What is the most important information I should know about COPAXONE? Call a healthcare provider right away if you have any of these immediate post-injection reaction symptoms including: redness to your cheeks or other parts of the body (flushing) chest pain fast heartbeat anxiety breathing problems or tightness in your throat swelling, rash, hives, or itching If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a healthcare provider tells you to. Chest Pain. […]
Source: FDA drug label, Teva Neuroscience, Inc., effective June 23, 2026 (SPL set aa88f583-4f5f-433b-80b4-1f4c9fb28357), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn controlled studies of COPAXONE 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) In a controlled study of COPAXONE 40 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1: Adverse Reactions in Controlled Clinical Trials with an Incidence ≥2% of Patients and More Frequent with COPAXONE (20 mg per mL Daily) than with Placebo
| Reaction | COPAXONE 20 mg/mL (n=563) % | Placebo (n=564) % |
|---|---|---|
| Lymphadenopathy | 7 | 3 |
| Palpitations | 9 | 4 |
| Eye Disorder | 3 | 1 |
| Nausea | 15 | 11 |
| Injection Site Erythema | 43 | 10 |
| Hypersensitivity | 3 | 2 |
| Infection | 30 | 28 |
| Weight Increased | 3 | 1 |
| Back Pain | 12 | 10 |
| Benign Neoplasm of Skin | 2 | 1 |
| Tremor | 4 | 2 |
| Anxiety | 13 | 10 |
| Micturition Urgency | 5 | 4 |
| Dyspnea | 14 | 4 |
| Rash | 19 | 11 |
| Vasodilatation | 20 | 5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] Immediate Post-Injection Reaction [see Warnings and Precautions ( 5.2 )] Chest Pain [see Warnings and Precautions ( 5.3 )] Lipoatrophy and Skin Necrosis [see Warnings and Precautions ( 5.4 )] Potential Effects on Immune Response [see Warnings and Precautions ( 5.5 )] Hepatic Injury [see Warnings and Precautions ( 5.6 )] In controlled studies of COPAXONE 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) In a controlled study of COPAXONE 40 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Teva Neuroscience, Inc., effective June 23, 2026 (SPL set aa88f583-4f5f-433b-80b4-1f4c9fb28357), via openFDA; the full label on DailyMed
What do FAERS reports show?
62,165 reports list glatiramer among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,316 are coded as a death and 9,712 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Glatiramer: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions