Copaxone Side Effects

Please note - some side effects for Copaxone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Copaxone - for the Consumer

Copaxone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Copaxone:

Anxiety upon injection; back pain; chest tightness; diarrhea; ear pain; fever; flu symptoms or infection (fever, chills, sore throat); flushing; joint pain; loss of appetite; mild redness, pain, itching, or a lump at the injection site; nausea; neck pain; nervousness; pain; painful menstrual flow; rapid eye movement; skin nodules; stomach pain; sweating; swelling of the legs and feet; vomiting; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain or tightness; continuing flushing and anxiety long after injection; dizziness; fast heartbeat; memory loss; pounding in the chest; severe pain, redness, or swelling at injection site; sweating; tightness in the throat; tremor.

Copaxone Side Effects - for the Professional

Copaxone

• In controlled studies, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact TEVA at 1-800-221-4026 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Local

Local side effects have included injection site reactions which have been reported to occur frequently compared to placebo. Injection site reactions have included injection site pain (73%), erythema (66%), inflammation (49%), pruritus (40%), injection site mass (27%), induration (13%), welts (11%), and urticaria (5%).

Cardiovascular

Cardiovascular side effects noted in premarketing clinical trials have included transient chest pain in approximately 25% of patients. The pain usually lasted only a few minutes, and may or may not have been associated with postinjection reactions. Vasodilation (27%) and palpitations (17%) have been reported. Hypertension has also been frequently reported.

The chest pain did not lead to further adverse clinical sequelae, although EKG monitoring was not performed during initial investigations. The episodes usually begin at least 1 month after initiation of treatment. The etiology and clinical significance of this symptom is unknown.

Hematologic

Hematologic side effects including lymphadenopathy have been reported in up to 25% of patients.

Gastrointestinal

Gastrointestinal symptoms have included nausea (22%) and bowel urgency.

Respiratory

Respiratory side effects have included dyspnea (19%) and hyperventilation.

Hepatic

A 71-year-old male who had suffered from multiple sclerosis since 1992 experienced acute exacerbation of autoimmune hepatitis coincident with glatiramer therapy. He was treated with interferon beta-1b between 1994 and 2004. In January 2004, the interferon treatment was interrupted because of elevated serum liver enzyme activities. Two months later, glatiramer acetate 20 mg once a day was initiated. In May 2004, he presented with malaise and jaundice which was associated with elevated serum liver enzyme activities. In November 2005, the patient re-presented with fever, uncharacteristic abdominal symptoms, and elevated serum liver enzyme activities. At this stage, he was diagnosed with autoimmune hepatitis. As therapy, the patient commenced on budesonide 3 mg three times a day. The treatment led to a significant improvement of liver function tests. He was subsequently put on mycophenolate mofetil.

Hepatic side effects have been reported rarely. At least one case of hepatitis has been reported, in addition to a case of acute exacerbation of autoimmune hepatitis.

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