Does Copaxone (glatiramer) cause side effects?

Copaxone (glatiramer) is a combination of four amino acids (proteins) used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Copaxone's mechanism of action is not completely understood. Available data suggest that it may work by modifying immune processes by suppressing T-cells (white blood cells of the immune system) that cause inflammation and destruction of nerves in patients with MS. Copaxone does not cure MS. It decreases the number of MS flares and lesions in the brain.

Common side effects of Copaxone include

Immediately after injection with Copaxone, side effects may include flushing (warmth, redness, or tingly feeling), chest pain, fast heartbeat, anxiety, shortness of breath, and itching. These symptoms usually disappear quickly and usually do not require treatment. 

Serious side effects of Copaxone include

Drug interactions between Copaxone and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of Copaxone with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. Copaxone has not been formally evaluated in combination with interferon beta.

Before you use Copaxone, tell your doctor if you are pregnant or plan to become pregnant. It is unknown if Copaxone will harm a fetus. It is unknown if Copaxone passes into breast milk. Consult your doctor before breastfeeding

What are the important side effects of Copaxone (glatiramer)?

Common side effects include:

Other side effects include:

Possible serious side effects include:

Copaxone (glatiramer) side effects list for healthcare professionals

The following serious adverse reactions are described elsewhere in the labeling:

  • Immediate Post-Injection Reaction
  • Chest Pain
  • Lipoatrophy and Skin Necrosis
  • Potential Effects on Immune Response

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 practice.

Incidence In Controlled Clinical Trials

Copaxone 20 mg Per mL Per Day

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 signs and symptoms that occurred in at least 2% of patients treated with Copaxone 20 mg per mL 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 (20 mg per mL Daily) than with Placebo

Copaxone
20 mg/mL
(n=563)
%
Placebo
(n=564)
%
Blood And Lymphatic System DisordersLymphadenopathy73
Cardiac DisordersPalpitations94
Tachycardia52
Eye DisordersEye Disorder31
Diplopia32
Gastrointestinal DisordersNausea1511
Vomiting74
Dysphagia21
General Disorders And Administration Site ConditionsInjection Site Erythema4310
Injection Site Pain4020
Injection Site Pruritus274
Injection Site Mass266
Asthenia2221
Pain2017
Injection Site Edema194
Chest Pain136
Injection Site Inflammation91
Edema82
Injection Site Reaction81
Pyrexia65
Injection Site Hypersensitivity40
Local Reaction31
Chills31
Face Edema31
Edema Peripheral32
Injection Site Fibrosis21
Injection Site Atrophy*20
Immune System DisordersHypersensitivity32
Infections And InfestationsInfection3028
Influenza1413
Rhinitis75
Bronchitis65
Gastroenteritis64
Vaginal Candidiasis42
Metabolism And Nutrition DisordersWeight Increased31
Musculoskeletal And Connective Tissue DisordersBack Pain1210
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)Benign Neoplasm of Skin21
Nervous System DisordersTremor42
Migraine42
Syncope32
Speech Disorder21
Psychiatric DisordersAnxiety1310
Nervousness21
Renal And Urinary DisordersMicturition Urgency54
Respiratory, Thoracic And Mediastinal DisordersDyspnea144
Cough65
Laryngospasm21
Skin And Subcutaneous Tissue DisordersRash1911
Hyperhidrosis75
Pruritus54
Urticaria31
Skin Disorder31
Vascular DisordersVasodilatation205
*Injection site atrophy comprises terms relating to localized lipoatrophy at injection site

Adverse reactions which occurred only in 4 to 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 of Copaxone 20 mg per mL 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

Cardiovascular

Digestive

Endocrine

Gastrointestinal

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

Hemic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Nervous

Respiratory

Skin and Appendages

Special Senses

Urogenital

Copaxone 40 mg per mL Three Times Per Week

Among 943 patients treated with Copaxone 40 mg per mL three times per week in a blinded, placebo-controlled trial, approximately 3% of the subjects discontinued treatment because of an adverse reaction. The most common adverse reactions were injection site reactions, which were also the most common cause of discontinuation.

Table 2 lists signs and symptoms that occurred in at least 2% of patients treated with Copaxone 40 mg per mL in the blinded, placebo-controlled trial. These signs and symptoms were numerically more common in patients treated with Copaxone 40 mg per mL than in patients treated with placebo. Adverse reactions were usually mild in intensity.

Table 2: Adverse Reactions in a Controlled Clinical Trial with an Incidence ≥2% of Patients and More Frequent with Copaxone (40 mg per mL Three Times per Week) than with Placebo

Copaxone
40 mg/mL
(n=943)
%
Placebo
(n=461)
%
General Disorders And Administration Site ConditionsInjection Site Erythema222
Injection Site Pain102
Injection Site Mass60
Injection Site Pruritus60
Injection Site Edema60
Pyrexia32
Influenza-like Illness32
Injection Site Inflammation20
Chills20
Chest Pain21
Infections And InfestationsNasopharyngitis119
Respiratory Tract Infection Viral32
Respiratory, Thoracic and Mediastinal DisordersDyspnea30
Vascular DisordersVasodilatation30
Gastrointestinal DisordersNausea21
Skin And Subcutaneous Tissue DisordersErythema20
Rash21

No new adverse reactions appeared in subjects treated with Copaxone 40 mg per mL three times per week as compared to subjects treated with Copaxone 20 mg per mL per day in clinical trials and during postmarketing experience. Data on adverse reactions occurring in the controlled clinical trial of Copaxone 40 mg per mL were analyzed to evaluate differences based on sex.

No clinically significant differences were identified. Ninety-eight percent of patients in this clinical trial were Caucasian and the majority were between the ages of 18 and 50. Consequently, data are inadequate to perform an analysis of the adverse reaction incidence related to clinically-relevant age groups.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Copaxone. Because these reactions 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.

What drugs interact with Copaxone (glatiramer)?

  • Interactions between Copaxone and other drugs have not been fully evaluated.
  • Results from existing clinical trials do not suggest any significant interactions of Copaxone with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days.
  • Copaxone has not been formally evaluated in combination with interferon beta.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 11/25/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.