Copaxone Side Effects

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

Side Effects of Copaxone - for the Consumer

Copaxone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Copaxone:

Anxiety; back pain; flushing; headache; mild redness, pain, itching, or a lump at the injection site; nausea; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Copaxone:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain or tightness; dizziness; fast or irregular heartbeat; fever, chills, or sore throat; persistent flushing or anxiety; pounding in the chest; severe pain, redness, or swelling at injection site; shortness of breath; skin hardening, thinning, or color change at the injection site; sweating; tightness in the throat; tremor; unusual swelling; vaginal odor, discharge, or itching.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Copaxone Side Effects - for the Professional

Copaxone

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Incidence in Controlled Clinical Trials

Among 563 patients treated with Copaxone in blinded placebo controlled trials, approximately 5% of the subjects discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: injection site reactions, dyspnea, urticaria, vasodilatation, and hypersensitivity. The most common adverse reactions were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain.

Table 1 lists treatment-emergent signs and symptoms that occurred in at least 2% of patients treated with Copaxone in the placebo-controlled trials. These signs and symptoms were numerically more common in patients treated with Copaxone than in patients treated with placebo. Adverse reactions were usually mild in intensity.

Table 1: Adverse reactions in controlled clinical trials with an incidence ≥2% of patients and more frequent with Copaxone than with placebo

		GA 20 mg (N=563)	Placebo (N=564)
* Injection site atrophy comprises terms relating to localized lipoatrophy at injection site
Blood And Lymphatic System Disorders	Lymphadenopathy	7%	3%
Cardiac Disorders	Palpitations	9%	4%
	Tachycardia	5%	2%
Eye Disorders	Eye Disorder	3%	1%
	Diplopia	3%	2%
Gastrointestinal Disorders	Nausea	15%	11%
	Vomiting	7%	4%
	Dysphagia	2%	1%
General Disorders And Administration Site Conditions	Injection Site Erythema	43%	10%
	Injection Site Pain	40%	20%
	Injection Site Pruritus	27%	4%
	Injection Site Mass	26%	6%
	Asthenia	22%	21%
	Pain	20%	17%
	Injection Site Edema	19%	4%
	Chest Pain	13%	6%
	Injection Site Inflammation	9%	1%
	Edema	8%	2%
	Injection Site Reaction	8%	1%
	Pyrexia	6%	5%
	Injection Site Hypersensitivity	4%	0%
	Local Reaction	3%	1%
	Chills	3%	1%
	Face Edema	3%	1%
	Edema Peripheral	3%	2%
	Injection Site Fibrosis	2%	1%
	Injection Site Atrophy*	2%	0%
Immune System Disorders	Hypersensitivity	3%	2%
Infections And Infestations	Infection	30%	28%
	Influenza	14%	13%
	Rhinitis	7%	5%
	Bronchitis	6%	5%
	Gastroenteritis	6%	4%
	Vaginal Candidiasis	4%	2%
Metabolism And Nutrition Disorders	Weight Increased	3%	1%
Musculoskeletal And Connective Tissue Disorders	Back Pain	12%	10%
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)	Benign Neoplasm of Skin	2%	1%
Nervous System Disorders	Tremor	4%	2%
	Migraine	4%	2%
	Syncope	3%	2%
	Speech Disorder	2%	1%
Psychiatric Disorders	Anxiety	13%	10%
	Nervousness	2%	1%
Renal And Urinary Disorders	Micturition Urgency	5%	4%
Respiratory, Thoracic And Mediastinal Disorders	Dyspnea	14%	4%
	Cough	6%	5%
	Laryngospasm	2%	1%
Skin And Subcutaneous Tissue Disorders	Rash	19%	11%
	Hyperhidrosis	7%	5%
	Pruritus	5%	4%
	Urticaria	3%	1%
	Skin Disorder	3%	1%
Vascular Disorders	Vasodilatation	20%	5%

Adverse reactions which occurred only in 4-5 more subjects in the Copaxone group than in the placebo group (less than 1% difference), but for which a relationship to Copaxone could not be excluded, were arthralgia and herpes simplex.

Laboratory analyses were performed on all patients participating in the clinical program for Copaxone. Clinically significant laboratory values for hematology, chemistry, and urinalysis were similar for both Copaxone and placebo groups in blinded clinical trials. In controlled trials one patient discontinued treatment due to thrombocytopenia (16 x109/L), which resolved after discontinuation of treatment.

Data on adverse reactions occurring in the controlled clinical trials were analyzed to evaluate differences based on sex. No clinically significant differences were identified. Ninety-six percent of patients in these clinical trials were Caucasian. The majority of patients treated with Copaxone were between the ages of 18 and 45. Consequently, data are inadequate to perform an analysis of the adverse reaction incidence related to clinically relevant age subgroups.

Other Adverse Reactions

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include reactions observed in open and uncontrolled premarketing studies (n= 979), the role of Copaxone in their causation cannot be reliably determined. Furthermore, variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used Copaxone and reported a reaction divided by the total number of patients exposed to Copaxone. All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: Frequent adverse reactions are defined as those occurring in at least 1/100 patients and infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients.

Body as a Whole:

 

Frequent: Abscess

 

Infrequent: Injection site hematoma, injection site fibrosis, moon face, cellulitis, generalized edema, hernia, injection site abscess, serum sickness, suicide attempt, injection site hypertrophy, injection site melanosis, lipoma, and photosensitivity reaction.

Cardiovascular:

 

Frequent: Hypertension.

 

Infrequent: Hypotension, midsystolic click, systolic murmur, atrial fibrillation, bradycardia, fourth heart sound, postural hypotension, and varicose veins.

Digestive:

 

Infrequent: Dry mouth, stomatitis, burning sensation on tongue, cholecystitis, colitis, esophageal ulcer, esophagitis, gastrointestinal carcinoma, gum hemorrhage, hepatomegaly, increased appetite, melena, mouth ulceration, pancreas disorder, pancreatitis, rectal hemorrhage, tenesmus, tongue discoloration, and duodenal ulcer.

Endocrine:

 

Infrequent: Goiter, hyperthyroidism, and hypothyroidism.

Gastrointestinal:

 

Frequent: Bowel urgency, oral moniliasis, salivary gland enlargement, tooth caries, and ulcerative stomatitis.

Hemic and Lymphatic:

 

Infrequent: Leukopenia, anemia, cyanosis, eosinophilia, hematemesis, lymphedema, pancytopenia, and splenomegaly.

Metabolic and Nutritional:

 

Infrequent: Weight loss, alcohol intolerance, Cushing's syndrome, gout, abnormal healing, and xanthoma.

Musculoskeletal:

 

Infrequent: Arthritis, muscle atrophy, bone pain, bursitis, kidney pain, muscle disorder, myopathy, osteomyelitis, tendon pain, and tenosynovitis.

Nervous:

 

Frequent: Abnormal dreams, emotional lability, and stupor.

 

Infrequent: Aphasia, ataxia, convulsion, circumoral paresthesia, depersonalization, hallucinations, hostility, hypokinesia, coma, concentration disorder, facial paralysis, decreased libido, manic reaction, memory impairment, myoclonus, neuralgia, paranoid reaction, paraplegia, psychotic depression, and transient stupor.

Respiratory:

 

Frequent: Hyperventilation and hay fever.

 

Infrequent: Asthma, pneumonia, epistaxis, hypoventilation, and voice alteration.

Skin and Appendages:

 

Frequent: Eczema, herpes zoster, pustular rash, skin atrophy, and warts.

 

Infrequent: Dry skin, skin hypertrophy, dermatitis, furunculosis, psoriasis, angioedema, contact dermatitis, erythema nodosum, fungal dermatitis, maculopapular rash, pigmentation, benign skin neoplasm, skin carcinoma, skin striae, and vesiculobullous rash.

Special Senses:

 

Frequent: Visual field defect.

 

Infrequent: Dry eyes, otitis externa, ptosis, cataract, corneal ulcer, mydriasis, optic neuritis, photophobia, and taste loss.

Urogenital:

 

Frequent: Amenorrhea, hematuria, impotence, menorrhagia, suspicious papanicolaou smear, urinary frequency, and vaginal hemorrhage.

 

Infrequent: Vaginitis, flank pain (kidney), abortion, breast engorgement, breast enlargement, carcinoma in situ cervix, fibrocystic breast, kidney calculus, nocturia, ovarian cyst, priapism, pyelonephritis, abnormal sexual function, and urethritis.

Postmarketing Experience

Reports of adverse events occurring under treatment with Copaxone not mentioned above that have been received since market introduction and may or may not have causal relationship to Copaxone are listed below. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: sepsis; SLE syndrome; hydrocephalus; enlarged abdomen; injection site hypersensitivity; allergic reaction; anaphylactoid reaction

Cardiovascular System: thrombosis; peripheral vascular disease; pericardial effusion; myocardial infarct; deep thrombophlebitis; coronary occlusion; congestive heart failure; cardiomyopathy; cardiomegaly; arrhythmia; angina pectoris

Digestive System: tongue edema; stomach ulcer; hemorrhage; liver function abnormality; liver damage; hepatitis; eructation; cirrhosis of the liver; cholelithiasis

Hemic and Lymphatic System: thrombocytopenia; lymphoma-like reaction; acute leukemia

Metabolic and Nutritional Disorders: hypercholesterolemia

Musculoskeletal System: rheumatoid arthritis; generalized spasm

Nervous System: myelitis; meningitis; CNS neoplasm; cerebrovascular accident; brain edema; abnormal dreams; aphasia; convulsion; neuralgia

Respiratory System: pulmonary embolus; pleural effusion; carcinoma of lung; hay fever

Special Senses: glaucoma; blindness; visual field defect

Urogenital System: urogenital neoplasm; urine abnormality; ovarian carcinoma; nephrosis; kidney failure; breast carcinoma; bladder carcinoma; urinary frequency

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Side Effects by Body System - for Healthcare Professionals

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 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.

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