Copaxone Side Effects
Generic name: glatiramer
Medically reviewed by Drugs.com. Last updated on Apr 13, 2024.
Note: This document provides detailed information about Copaxone 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.
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:
More common
- anxiety
- bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the injection site
- chest pain
- cough or hoarseness
- excessive muscle tone
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- fever or chills
- joint pain
- lower back or side pain
- neck pain
- painful or difficult urination
- redness of the face, neck, arms, and occasionally, upper chest
- skin rash
- swelling or puffiness of the face
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trouble breathing
Less common
- agitation
- bloating or swelling
- chest tightness
- confusion
- difficulty with swallowing
- feeling faint, dizzy, or lightheaded
- headache, severe and throbbing
- itching of the vagina or outside genitals
- muscle aches or pain
- pain during sexual intercourse
- purple spots under the skin
- 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
- thick, white curd-like vaginal discharge without odor or with mild odor
- tingling of the hands or feet
- trembling or shaking of the hands or feet
- unusual weight gain or loss
Rare
- 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
- 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
Incidence not known
- abnormal vaginal bleeding or discharge
- back pain, sudden and severe
- bleeding gums
- blindness
- blurred or decreased vision
- chest discomfort or heaviness
- clear or bloody discharge from the nipple
- cloudy urine
- coughing up blood
- dark urine
- decreased urine output
- difficult or frequent urination
- dilated neck veins
- dimpling of the breast skin
- drowsiness
- extreme tiredness or weakness
- eye pain
- gaseous stomach pain
- general feeling of discomfort or illness
- general tiredness and weakness
- hair loss
- headache
- heartburn
- increased menstrual flow or vaginal bleeding
- indigestion
- inverted nipple
- joint swelling
- large amount of cholesterol in the blood
- light-colored stools
- lump in the breast or under the arm
- lump or swelling in the stomach
- muscle weakness, sudden and progressing
- nausea
- nerve pain
- nosebleed
- pain or discomfort the in arms or jaw
- paralysis
- persistent crusting or scaling of the nipple
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, lips, or tongue
- rapid, shallow breathing
- recurrent fever
- red or black, tarry stools
- redness or swelling of the breast
- seizures
- sore on the skin of the breast that does not heal
- sore throat
- stiff neck or back
- stomach bloating, burning, cramping, or pain
- tearing
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- yellow eyes or skin
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:
More common
- lack or loss of strength
- stuffy or runny nose
Less common
- double vision
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. (2001) "Product Information. Copaxone (glatiramer)." Teva Pharmaceuticals USA
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp
Frequently asked questions
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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.
Some side effects may not be reported. You may report them to the FDA.