Summary

Commonly reported side effects of glatiramer include: anxiety, chest pain, dyspnea, lymphadenopathy, palpitations, post-injection flare, urticaria, vasodilation, 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. Continue reading for a comprehensive list of adverse effects.

Applies to glatiramer: subcutaneous solution.

Serious side effects of Glatiramer

Along with its needed effects, glatiramer 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 Glatiramer

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]