Copaxone Side Effects

Generic Name: glatiramer

Note: This page contains information about the side effects of glatiramer. Some of the dosage forms included on this document may not apply to the brand name Copaxone.

Not all side effects for Copaxone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to glatiramer: subcutaneous kit, subcutaneous powder for solution, subcutaneous solution

Along with its needed effects, glatiramer (the active ingredient contained in Copaxone) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking glatiramer:

More common
  • Anxiety
  • bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the place of injection
  • chest pain
  • cough
  • excessive muscle tone
  • fast, irregular, pounding, or racing heartbeat or pulse
  • flushing
  • joint pain
  • lower back or side pain
  • neck pain
  • painful or difficult urination
  • skin rash
  • swelling or puffiness of the face
  • swollen lymph glands
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • troubled breathing
Less common
  • Agitation
  • bloating or swelling
  • chills
  • confusion
  • difficulty with swallowing
  • feeling faint, dizzy, or lightheaded
  • fever
  • headache, severe and throbbing
  • itching of the vagina or outside genitals
  • muscle aches
  • pain
  • pain during sexual intercourse
  • purple spots under the skin
  • rapid weight gain
  • red streaks on the skin
  • shakiness in the legs, arms, hands, or feet
  • small lumps under the skin
  • spasm of the throat
  • strong urge to urinate
  • sweating
  • swelling of the fingers, arms, feet, or legs
  • swelling or puffiness of the face
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • tightness in the chest
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • unusual weight gain or loss
Rare
  • Back pain
  • blood in the urine
  • burning or stinging of the skin
  • continuous, uncontrolled back-and-forth or rolling eye movements
  • decreased sexual ability
  • diarrhea
  • difficulty with moving
  • ear pain
  • fast breathing
  • irritation of the mouth and tongue (thrush)
  • loss of appetite
  • menstrual pain or changes
  • muscle pain
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • sensation of motion, usually whirling, either of oneself or of one's surroundings
  • speech problems
  • vision problems

Some side effects of glatiramer may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
  • increased sweating
  • lack or loss of strength
  • nausea
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
  • vomiting
Less common
  • Double vision
  • seeing double
  • weight gain

For Healthcare Professionals

Applies to glatiramer: subcutaneous kit, subcutaneous powder for injection, subcutaneous solution

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 (the active ingredient contained in Copaxone) 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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