35/100 · Moderate
Manufactured by Teva Neuroscience, Inc.
Multiple Sclerosis Treatment: Common and Less Severe Reactions Predominate
108,384 FDA adverse event reports analyzed
Last updated: 2026-05-12
GLATIRAMER ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Teva Neuroscience, Inc.. Based on analysis of 108,384 FDA adverse event reports, GLATIRAMER ACETATE has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for GLATIRAMER ACETATE include MULTIPLE SCLEROSIS RELAPSE, INJECTION SITE PAIN, DRUG INEFFECTIVE, INJECTION SITE REACTION, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GLATIRAMER ACETATE.
Glatiramer Acetate has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 108,384 adverse event reports for this medication, which is primarily manufactured by Teva Neuroscience, Inc..
The most commonly reported adverse events include Multiple Sclerosis Relapse, Injection Site Pain, Drug Ineffective. Of classified reports, 46.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are common and less severe, such as injection site pain and fatigue.
Serious reactions, while present, are less frequent, with the most serious being anaphylactic reactions and death. The reaction diversity is high, with over 100 distinct reactions reported. The most common reactions are related to injection site issues and general discomfort.
Patients taking Glatiramer Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs are not commonly reported, but patients should be monitored for injection site reactions and general discomfort. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Glatiramer Acetate received a safety concern score of 35/100 (moderate concern). This is based on a 46.0% serious event ratio across 58,854 classified reports. The score accounts for 108,384 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 44,832, Male: 10,869, Unknown: 340. The most frequently reported age groups are age 55 (801 reports), age 54 (780 reports), age 52 (759 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 58,854 classified reports for GLATIRAMER ACETATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Interactions with other drugs are not commonly reported, but patients should be monitored for injection site reactions and general discomfort.
If you are taking Glatiramer Acetate, here are important things to know. The most commonly reported side effects include multiple sclerosis relapse, injection site pain, drug ineffective, injection site reaction, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any serious or unusual reactions to their healthcare provider immediately. Follow the prescribed injection technique to minimize the risk of injection site reactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of glatiramer acetate and has not issued any specific regulatory actions based on this data.
The FDA has received approximately 108,384 adverse event reports associated with Glatiramer Acetate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Glatiramer Acetate include Multiple Sclerosis Relapse, Injection Site Pain, Drug Ineffective, Injection Site Reaction, Fatigue. By volume, the top reported reactions are: Multiple Sclerosis Relapse (5,118 reports), Injection Site Pain (4,898 reports), Drug Ineffective (3,848 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Glatiramer Acetate.
Out of 58,854 classified reports, 27,074 (46.0%) were classified as serious and 31,780 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Glatiramer Acetate break down by patient sex as follows: Female: 44,832, Male: 10,869, Unknown: 340. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Glatiramer Acetate adverse events are: age 55: 801 reports, age 54: 780 reports, age 52: 759 reports, age 48: 755 reports, age 53: 741 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Glatiramer Acetate adverse event reports is Teva Neuroscience, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Glatiramer Acetate include: Multiple Sclerosis, Dyspnoea, Fall, Injection Site Erythema, Gait Disturbance. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Glatiramer Acetate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Glatiramer Acetate has a safety concern score of 35 out of 100 (moderate concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of reported reactions are common and less severe, such as injection site pain and fatigue.
Key safety signals identified in Glatiramer Acetate's adverse event data include: Injection site reactions are the most frequently reported, indicating potential local side effects.. Fatigue and pain are among the top reported reactions, suggesting a need for patient education on managing these symptoms.. Serious reactions, though less common, include anaphylactic reactions and death, highlighting the need for careful monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs are not commonly reported, but patients should be monitored for injection site reactions and general discomfort. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Glatiramer Acetate.
Patients should report any serious or unusual reactions to their healthcare provider immediately. Follow the prescribed injection technique to minimize the risk of injection site reactions.
Glatiramer Acetate has 108,384 adverse event reports on file with the FDA. Serious reactions, while present, are less frequent, with the most serious being anaphylactic reactions and death. The volume of reports for Glatiramer Acetate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of glatiramer acetate and has not issued any specific regulatory actions based on this data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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