Copaxone Side Effects

Generic name: glatiramer

Medically reviewed by Drugs.com. Last updated on Oct 27, 2024.

Note: This document provides detailed information about Copaxone.

Applies to glatiramer: subcutaneous solution Side Effects associated with glatiramer. Some dosage forms listed on this page may not apply specifically to the brand name Copaxone.

Applies to glatiramer: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Some patients have a reaction to this medicine a few minutes after receiving a shot. The symptoms might include: chest pain, flushing, fast, irregular, or pounding heartbeat, anxiety, trouble breathing, a tight feeling in the throat, or hives. These symptoms will usually go away without treatment in a short time. Call your doctor right away if these symptoms become worse or do not go away. This reaction can happen even if you have used the medicine regularly for several months. Also, chest pain can occur by itself, but should not last more than a few minutes.

This medicine may cause serious skin problems, including a permanent depression (dent) under the skin at the injection site. Contact your doctor right away if you have depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin at the injection site.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, liver failure, hepatitis with jaundice).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Copaxone

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:

Other side effects of Copaxone

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:

For healthcare professionals

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

Local adverse events

• 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]

See also:

Frequently asked questions

• Where and how should Copaxone be injected?
• What happens if an MS patient stops taking Copaxone?
• How long can you take Copaxone?
• How long does it take for Copaxone to be effective?
• How does Copaxone work for multiple sclerosis?

Further information

Copaxone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer