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About Glatiramer

Glatiramer Acetate Injection Side Effects

Important safety information about potential side effects and when to seek emergency care.

WHAT TO EXPECT WITH YOUR MEDICATION

Glatiramer Acetate Injection Side Effects

Like all medicines, Glatiramer Acetate Injection can cause side effects. Not everyone experiences the same side effects.

REPORTED IN CLINICAL STUDIES

Common Side Effects

The most common side effects in clinical studies include:

Injection-site reactions

Redness, pain, swelling, itching, bruising, or a lump at the injection site

Flushing

Warmth or redness of the face, neck, or chest

Rash

May occur at various areas of the body

Shortness of breath

May occur after injection

Chest pain

May be temporary — contact your provider if it persists

Anxiety, palpitations, or rapid heartbeat

May occur after injection

These are not all possible side effects. For a complete list, see the Full Prescribing Information and Medication Guide.

OCCURS WITHIN MINUTES OF INJECTION

Immediate Post-Injection Reaction

Some patients experience a reaction within seconds to minutes after injecting. Symptoms may include:

  • Flushing (redness and warmth)
  • Chest pain or tightness
  • Heart racing or palpitations
  • Anxiety
  • Difficulty breathing or feeling of throat tightening
  • Hives or skin flushing

These reactions are generally temporary and resolve on their own without treatment. If you experience these symptoms:

Contact your provider

Reach out to your healthcare provider after the reaction to discuss.

Do not re-inject

Do not give yourself another injection until your doctor advises you to.

LIFE-THREATENING — ACT IMMEDIATELY

Serious Reactions — Seek Emergency Help

STOP using Glatiramer Acetate Injection and call 911 or go to the nearest emergency room IMMEDIATELY if you experience any of the following:

  • Widespread rash or hives over large areas of the body
  • Swelling of the face, eyelids, lips, tongue, mouth, or throat
  • Sudden severe shortness of breath, difficulty breathing, or wheezing
  • Uncontrolled shaking or convulsions
  • Trouble swallowing or speaking
  • Fainting or extreme dizziness

Symptoms of an immediate post-injection reaction may overlap with symptoms of anaphylaxis. Seek emergency medical help right away if you have signs or symptoms of a serious allergic reaction. Do not give yourself another injection until your healthcare provider tells you to.

LONG-TERM INJECTION SITE CHANGES

Skin Changes at Injection Sites

With long-term use, some patients develop:

Lipoatrophy

Permanent denting or dimpling of the skin at injection sites

Skin discoloration

Changes in skin color at the injection site

Skin necrosis (rare)

Tissue death at the injection site — contact your provider immediately if this occurs

Rotating injection sites with each injection may help minimize the risk of injection-site skin changes.
HEPATIC SAFETY MONITORING

Liver Injury

Liver problems, including liver failure, can occur with Glatiramer Acetate Injection. Contact your healthcare provider right away if you notice:

  • Nausea or loss of appetite
  • Unusual tiredness or weakness
  • Dark-colored urine or pale stools
  • Yellowing of the skin or whites of the eyes (jaundice)
  • Bleeding more easily than normal
  • Confusion or unusual drowsiness
REPORTING ADVERSE EVENTS

Reporting Side Effects

Tell your doctor about any side effects that concern you. You can also report side effects directly to the FDA:

Online Reporting

www.fda.gov/medwatch

FDA MedWatch — available 24/7

By Phone

1-800-FDA-1088

FDA MedWatch phone line

IMPORTANT:

This is not a complete list of side effects. Please read the Full Prescribing Information and Medication Guide for complete safety information. Contact your healthcare provider with any concerns.

QUICK LINKS

Have a question?

Contact our Medical Information line for clinical questions.

Medical Info Line:

1-727-234-8872

Mon–Fri, 8am–8pm ET