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Copaxone Side Effects

Generic Name: glatiramer

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

In Summary

Common side effects of Copaxone include: anxiety, chest pain, dyspnea, lymphadenopathy, palpitations, post-injection flare, urticaria, vasodilatation, flushing, erythema at injection site, induration at injection site, inflammation at injection site, itching at injection site, and pain at injection site. Other side effects include: eye disease, facial edema, laryngospasm, and chills. See below for a comprehensive list of adverse effects.

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

Very common (10% or more): Injection site erythema (43%), injection site pain (40%), injection site pruritus (27%), injection site mass (26%), injection site edema (19%)
Common (1% to 10%): Injection site inflammation, injection site reaction, injection site hypersensitivity, injection site fibrosis, injection site atrophy
Uncommon (0.1% to 1%): Injection site hematoma, injection site abscess, injection site hypertrophy, injection site melanosis[Ref]

Cardiovascular

Very common (10% or more): Vasodilation (20%), chest pain (13%)
Common (1% to 10%): Palpitations, tachycardia, hypertension
Uncommon (0.1% to 1%): Hypotension, midsystolic click, systolic murmur, atrial fibrillation, bradycardia, fourth heart sound, postural hypotension, varicose veins, warts, dry skin
Postmarketing reports: Thrombosis, peripheral vascular disease, pericardial effusion, myocardial infarct, deep thrombophlebitis, coronary occlusion, congestive heart failure, cardiomyopathy, cardiomegaly, arrhythmia, angina pectoris[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy
Uncommon (0.1% to 1%): Leukopenia, anemia, cyanosis, eosinophilia, hematemesis, lymphedema, pancytopenia, splenomegaly[Ref]

Gastrointestinal

Very common (10% or more): Nausea (15%)
Common (1% to 10%): Vomiting, dysphagia, gastroenteritis
Uncommon (0.1% to 1%): Dry mouth, stomatitis, burning sensation on tongue, cholecystitis, colitis, esophageal ulcer, esophagitis, gastrointestinal carcinoma, gum hemorrhage, increased appetite, melena, mouth ulceration, pancreas disorder, pancreatitis, rectal hemorrhage, tenesmus, tongue discoloration, duodenal ulcer, circumoral paresthesia[Ref]

Respiratory

Very common (10% or more): Dyspnea (14%)
Common (1% to 10%): Rhinitis, bronchitis, cough, laryngospasm, hyperventilation, hay fever
Uncommon (0.1% to 1%): Asthma, pneumonia, epistaxis, hypoventilation, voice alteration
Postmarketing reports: Pulmonary embolus, pleural effusion, carcinoma of lung[Ref]

Hepatic

Postmarketing reports: Cirrhosis of the liver, cholelithiasis hepatomegaly[Ref]

Dermatologic

Very common (10% or more): Rash (19%)
Common (1% to 10%): Hyperhidrosis, pruritus, urticaria, skin disorder, eczema, herpes zoster, pustular rash, skin atrophy, warts
Uncommon (0.1% to 1%): Dry skin, skin hypertrophy, dermatitis, furunculosis, psoriasis, angioedema, contact dermatitis, erythema nodosum, fungal dermatitis, maculopapular rash, pigmentation, benign skin neoplasm, skin carcinoma, skin striae, vesiculobullous rash
Postmarketing reports: Thrombocytopenia[Ref]

Endocrine

Uncommon (0.1% to 1%): Goitre, hyperthyroidism, hypothyroidism[Ref]

Genitourinary

Common (1% to 10%): Vaginal candidiasis, micturition urgency, amenorrhea, hematuria, impotence, menorrhagia, suspicious Papanicolaou smear, urinary frequency, vaginal hemorrhage
Uncommon (0.1% to 1%): Decreased libido, vaginitis, abortion, breast engorgement, breast enlargement, carcinoma in situ cervix, fibrocystic breast, kidney calculus, nocturia, ovarian cyst, priapism, pyelonephritis, abnormal sexual function, urethritis
Postmarketing reports: Urogenital neoplasm, urine abnormality, ovarian carcinoma, nephrosis, breast carcinoma, bladder carcinoma[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity, allergic reaction, anaphylactoid reaction[Ref]

Immunologic

Very common (10% or more): Infection (30%), influenza (14%)
Common (1% to 10%): Abscess
Uncommon (0.1% to 1%): Cellulitis, serum sickness[Ref]

Metabolic

Common (1% to 10%): Weight gain
Postmarketing reports: Hypercholesterolemia[Ref]

Musculoskeletal

Very common (10% or more): Back pain (12%)
Common (1% to 10%): Chills
Uncommon (0.1% to 1%): Lipoma, arthritis, muscle atrophy, bone pain, bursitis, muscle disorder, myopathy, osteomyelitis, tendon pain, tenosynovitis
Postmarketing reports: Systemic lupus erythematosus (SLE), rheumatoid arthritis, generalized spasm[Ref]

Nervous system

Very common (10% or more): Pain (20%)
Common (1% to 10%): Tremor, migraine, syncope, speech disorder
Uncommon (0.1% to 1%): Convulsion, hypokinesia, coma, facial paralysis, myoclonus, neuralgia, paraplegia
Postmarketing reports: Hydrocephalus, myelitis, meningitis, CNS neoplasm, cerebrovascular accident, brain edema, neuralgia[Ref]

Ocular

Common (1% to 10%): Eye disorder, diplopia, visual field defect
Uncommon (0.1% to 1%): Photosensitivity, dry eyes, otitis externa, ptosis, cataract, corneal ulcer, mydriasis, optic neuritis, photophobia
Postmarketing reports: Glaucoma, vision loss[Ref]

Oncologic

Common (1% to 10%): Benign neoplasm of skin
Postmarketing reports: Lymphoma-like reaction, acute leukemia[Ref]

Other

Very common (10% or more): Asthenia (22%)
Common (1% to 10%): Edema, face edema, peripheral edema
Uncommon (0.1% to 1%): Aphasia, ataxia, taste loss[Ref]

Psychiatric

Very common (10% or more): Anxiety (13%)
Common (1% to 10%): Nervousness, abnormal dreams, emotional lability, stupor
Uncommon (0.1% to 1%): Suicide attempt, depersonalization, hallucinations, hostility, concentration disorder, manic reaction, memory impairment, paranoid reaction, psychotic depression, transient stupor[Ref]

Renal

Uncommon (0.1% to 1%): Kidney pain, kidney calculus
Postmarketing reports: Kidney failure[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

3. "Product Information. Copaxone (glatiramer)." Teva Pharmaceuticals USA, Kulpsville, PA.

Some side effects of Copaxone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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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