In controlled studies of GA injection 20 mg/mL, most common adverse reactions (≥ 10% and ≥ 1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain.
Among 563 patients treated with GA injection in blinded placebo-controlled trials, approximately 5% of the subjects discontinued treatment because of an adverse reaction.
Table: Adverse Reactions in a Controlled Clinical Trial with an Incidence ≥ 2% of Patients and More Frequent with GA Injection (20 mg/mL Daily) than with Placebo
Glatiramer
Acetate Injection
20 mg/mL (n = 563) % | Placebo (n = 564) % | ||
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 | |
Injection Site Edema | 19 | 4 | |
Chest Pain | 13 | 6 | |
Injection Site Inflammation | 9 | 1 | |
Injection Site Reaction | 8 | 1 | |
Injection Site Hypersensitivity | 4 | 0 | |
Injection Site Fibrosis | 2 | 1 | |
Injection Site Atrophy* | 2 | 0 | |
Respiratory, Thoracic and Mediastinal Disorders | Dyspnea | 14 | 4 |
Skin and Subcutaneous Tissue Disorders | Rash | 19 | 11 |
Vascular Disorders | Vasodilatation | 20 | 5 |
*Injection site atrophy comprises terms relating to localized lipoatrophy at injection site