FDA-filed SPL labeling · retrieved through openFDA

Glatiramer Injection

Glatiramer acetate injection (brands include Copaxone and Glatopa) is a subcutaneous injection used to treat relapsing forms of multiple sclerosis in adults.

Brand names CopaxoneGlatopa
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 13 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 23, 2026
Clinical labels in scope ⓘ13
AvailabilityRx
Earliest approval/marketing year ⓘ1996
FDA-listed product records ⓘ43
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026
⭐ Glatiramer Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Glatiramer acetate injection (Copaxone, Glatopa) is a proven subcutaneous treatment for relapsing forms of multiple sclerosis in adults. The most important safety concern is anaphylaxis — a rare but potentially life-threatening allergic reaction that can occur at any time, so know the warning signs and seek emergency help immediately if they appear. Rotating your injection sites and using the correct product and syringe as prescribed will help you get the most from your treatment safely.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Glatiramer acetate injection carries a boxed warning — the FDA's most serious safety alert — about life-threatening and fatal anaphylaxis (severe allergic reaction). This reaction can happen after the very first injection or at any point during treatment, even years later. Signs include sudden trouble breathing, throat tightening, rapid heartbeat, severe hives, and dizziness. Because these symptoms can look like a milder, common post-injection reaction, it is important not to wait — seek emergency medical care immediately if they occur. If you have ever had a serious allergic reaction to glatiramer acetate or mannitol, you must not use this medication. If anaphylaxis occurs, treatment must be stopped permanently unless another clear cause is found.

Read the full warning on DailyMed →

📖 Glatiramer Injection: Patient Information Guide

A plain-language walkthrough of Glatiramer Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Glatiramer acetate injection is approved for adults with relapsing forms of multiple sclerosis (MS). It covers the following forms:

  • Clinically isolated syndrome — a first neurological episode that may be an early sign of MS
  • Relapsing-remitting MS — the most common type, with defined flare-ups followed by partial or full recovery
  • Active secondary progressive MS — a later stage where disability gradually worsens but relapses are still occurring
⚙️How it works▾

Glatiramer acetate is thought to work by changing how the immune system behaves in MS. In MS, the immune system mistakenly attacks myelin — the protective sheath around nerve fibers in the brain and spinal cord. Glatiramer acetate appears to activate immune cells called suppressor T-cells that can dampen this abnormal attack. The exact mechanism is not fully understood, but this immune-modifying effect is the leading explanation for its benefit in MS.

Because glatiramer acetate influences immune function, there is a theoretical possibility it could affect the body's normal defenses against infection or tumors. This has not been proven, but your doctor will monitor you during treatment.

💊How it's taken▾

Glatiramer acetate injection is given as a subcutaneous (under-the-skin) shot — it must never be given into a vein. Two different strengths are available with different schedules:

  • Once-daily strength: injected every day
  • Three-times-weekly strength: injected three times per week, with at least 48 hours between doses

These two strengths are not interchangeable — do not switch between them without your prescriber's guidance. Always let the prefilled syringe warm to room temperature for about 20 minutes before each injection, and rotate your injection site every time to protect the skin.

🤒Side effects — in detail▾

Most side effects are mild and manageable. The most common ones include:

  • Injection site reactions: redness, pain, swelling, itching, and lumps at the injection site
  • Flushing (a sensation of warmth and redness)
  • Shortness of breath
  • Chest pain — usually brief and not dangerous
  • Rash and skin itching
  • Nausea
  • Anxiety
  • Rapid heartbeat (tachycardia) or palpitations

Seek emergency care right away for signs of a severe allergic reaction — such as throat tightening, difficulty breathing, severe hives, or sudden dizziness. Also call your doctor promptly if you notice yellowing of the skin or eyes, or significant changes at injection sites such as skin breakdown or loss of fat tissue.

⚠️Warnings & precautions▾
  • Anaphylaxis (life-threatening allergic reaction): This is the most serious risk. It can occur after any dose — including the first — and at any point in treatment. Signs include trouble breathing, throat constriction, hives, and rapid heartbeat. Seek emergency care immediately if this happens. Anyone with a prior serious allergic reaction to glatiramer acetate or mannitol must not use this drug.
  • Immediate post-injection reaction: A cluster of symptoms — flushing, chest tightness, palpitations, anxiety, shortness of breath — can appear within seconds to minutes of an injection. These are usually short-lived and not dangerous, but they can overlap with anaphylaxis, so always err on the side of caution.
  • Chest pain: Transient chest pain has been reported in a meaningful number of patients. It usually resolves on its own, but ongoing or severe chest pain should always be evaluated.
  • Skin and injection site changes: Loss of fat tissue under the skin (lipoatrophy) at injection sites may be permanent. Rarely, skin tissue death (necrosis) can occur. Rotating injection sites carefully at each dose reduces this risk.
  • Liver injury: Serious liver damage, including liver failure, has been reported — sometimes appearing years after starting treatment. Tell your doctor about any symptoms like jaundice, dark urine, or unusual fatigue.
  • Immune system effects: This medication modifies immune response. While no confirmed harms from this have been identified, the theoretical risk of reduced defense against infections or tumors exists and warrants monitoring.
🔀What it interacts with▾

The FDA label for glatiramer acetate injection does not identify specific drug, food, or supplement interactions. However, because this medication affects how the immune system works, your doctor should be aware of all other medications and supplements you take — especially anything else that affects immunity.

  • Immune-modifying or immunosuppressive drugs: Using other agents that alter immune function alongside glatiramer acetate could compound the risk of reduced immune defense, though no specific combinations are listed in the label

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to glatiramer acetate or mannitol: Do not use this medication if you have had a serious allergic reaction to either ingredient — this is an absolute contraindication
  • Pregnancy: Data from years of use and observational studies have not identified a clear risk of birth defects or miscarriage, but discuss the benefits and risks fully with your doctor before or during pregnancy
  • Breastfeeding: Very little drug is expected to reach breast milk because most is broken down locally at the injection site; however, there are no human data, and your doctor should be part of this decision
  • Children under 18: Safety and effectiveness have not been established in pediatric patients
  • Older adults: Glatiramer acetate injection has not been specifically studied in elderly patients; use with appropriate monitoring
  • Kidney problems: The drug's behavior in people with impaired kidney function has not been studied — tell your doctor if you have kidney disease
  • Liver problems: Given the risk of liver injury associated with this drug, people with pre-existing liver conditions should discuss risks carefully with their doctor
🔬Pharmacokinetics — how your body processes it▾

After a subcutaneous injection, a large portion of glatiramer acetate is broken down (hydrolyzed) locally at the injection site before it can enter the bloodstream. Fragments that are not immediately broken down may enter the lymphatic system, reaching nearby lymph nodes. A smaller fraction enters the general circulation either intact or partially hydrolyzed. This extensive local breakdown means that systemic (whole-body) drug exposure is low compared to the injected dose.

📦How to store it▾

Store Glatopa refrigerated at 2°C to 8°C (36°F to 46°F). store Glatopa at room temperature, 15°C to 30°C (59°F to 86°F), for up to one month, but refrigeration is preferred. Do not freeze Glatopa.

📄 Written from Glatiramer Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

53

Supplements & herbs that interact with Glatiramer Injection

53 supplements and herbal products have documented interactions with Glatiramer Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 52
  • Minor · 1
ACTIVE HEXOSE CORRELATED COMPOUND (AHCC) Moderate ALFALFA Moderate AMERICAN GINSENG Moderate ANDROGRAPHIS Moderate ASHWAGANDHA Moderate ASTRAGALUS Moderate BEE VENOM Moderate BETA-GLUCANS Moderate +45 more
Every supplement checked against Glatiramer Injection — ranked by severity The full interaction hub: 52 moderate · 1 minor · every one linked to its full report. Check Glatiramer Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Glatiramer Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is glatiramer acetate used for? ▾
It's a treatment for relapsing forms of multiple sclerosis (MS) in adults. That includes a first episode that might signal MS (called clinically isolated syndrome), the classic relapsing-remitting type, and active secondary progressive MS. It doesn't cure MS, but it's designed to reduce the frequency of relapses by calming down the immune system's mistaken attack on your nerve tissue.
How do I give myself the injection, and does it matter where I inject? ▾
Yes, where you inject absolutely matters. You inject under the skin — never into a vein — and you should rotate your injection sites every single time. Good spots include your upper arms, abdomen, hips, and thighs. Take the prefilled syringe out of the fridge about 20 minutes early so it warms up — injecting cold solution is more likely to irritate the skin. Before injecting, check that the liquid is clear or very slightly yellow with no visible particles.
What's the most important side effect I should know about? ▾
The biggest one to know is anaphylaxis — a serious, life-threatening allergic reaction. It can happen after your very first dose or even years into treatment. Signs include sudden trouble breathing, throat tightening, hives, rapid heartbeat, or severe dizziness. Here's the tricky part: there's also a milder, more common reaction called an immediate post-injection reaction that shares some of these symptoms. If you're ever unsure, don't wait — call emergency services right away. Better safe than sorry.
I felt chest pain after my injection — should I be worried? ▾
Chest pain after an injection is actually a known side effect and is usually brief and harmless. It often happens without any other symptoms and tends to go away on its own. That said, if your chest pain is severe, lasts a while, or comes with other concerning symptoms like difficulty breathing, you should seek medical care right away to be sure it isn't something more serious.
Can I take this if I'm pregnant or trying to get pregnant? ▾
Data collected over many years of use haven't shown a clear increased risk of birth defects or miscarriage, which is reassuring. But no medication decision during pregnancy should be made without your doctor's input. If you're planning a pregnancy or find out you're pregnant while on this medication, talk to your prescriber so you can weigh the benefits of staying on treatment against any potential risks together.
Is there anything I need to watch for with my skin at the injection site over time? ▾
Yes — over time, some people develop a condition called lipoatrophy, which means a small area of fat under the skin at the injection site gradually disappears. It can look like a dent or hollow and may be permanent. There's no treatment for it, but rotating your injection sites with every dose is the best way to reduce that risk. In rare cases, more serious skin breakdown can happen, so if you notice any unusual skin changes, show your doctor.
Is Glatiramer Injection available over the counter? ▾
Glatiramer Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Glatiramer Injection first available? ▾
Glatiramer Injection has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Glatiramer Injection? ▾
Glatiramer Injection is supplied by 10 manufacturers listed in the FDA NDC Directory, including Sandoz Inc, Teva Neuroscience, Inc., Bryant Ranch Prepack.

💬 Answers drafted from Glatiramer Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Glatiramer Injection supplement interactions53 checked — ranked by severity 🌿Drug & Supplement CheckerGlatiramer Injection vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Glatiramer Injection NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Glatiramer Injection comes

Glatiramer Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Under the skin
Brands Copaxone Glatopa
How this form is used
What it may be used for
  • Treats relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS
  • Available as two strengths: one injected once daily, the other injected three times per week — these are not interchangeable
Important instructions
  • For subcutaneous (under the skin) injection only — never inject into a vein
  • Remove the prefilled syringe from the refrigerator and let it warm at room temperature for 20 minutes before injecting
  • Check the solution before use — it should be clear and colorless to slightly yellow; discard if you see particles or unusual color
  • Rotate injection sites with each dose (arms, abdomen, hips, thighs); if using an optional autoinjector, confirm it is compatible with your specific glatiramer acetate product
Available strengths 3 strengths
20 mg/mL 40 mg/mL 1 kg/kg
43 FDA-listed product records ⓘ

📊 Glatiramer Injection across the U.S. market

How Glatiramer Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
10
Manufacturers
3
Brand names
43
FDA-listed product records ⓘ
1996
First marketed ⓘ
Sandoz Inc23%
Teva Neuroscience, Inc.19%
Bryant Ranch Prepack14%
Mylan Pharmaceuticals Inc.14%
Zydus Pharmaceuticals USA Inc.9%
Ajenat Pharmaceuticals Llc5%
Other makers16%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Glatiramer Injection is used

A general measure of how commonly Glatiramer Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Glatiramer Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

12,218
Medicaid prescriptions filled (Q1–Q4 2025)
$54.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Glatiramer Injection prescribed? Of the 1,596 medications we measure, Glatiramer Injection ranks #893 by Medicaid prescriptions — more than 44% of them.

Where Glatiramer Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #893 of 1,596
#888 Cyclophosphamide 12,778 Rx #889 Imatinib 12,484 Rx #890 Enalapril and Hydrochl... 12,397 Rx #891 Doxorubicin 12,297 Rx #892 Sertaconazole Topical 12,283 Rx #893 Glatiramer Injection 12,218 Rx #894 Phytonadione 12,205 Rx #895 Nitroglycerin Transder... 12,007 Rx #896 Everolimus 11,955 Rx #897 Famciclovir 11,935 Rx #898 Cyclophosphamide Injec... 11,741 Rx

Utilization by Glatiramer Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mL / 40 mg/mL prefilled syringe is the most-dispensed Glatiramer Injection product — about 80% of these Medicaid prescriptions.

1 ML glatiramer acetate 40 MG/ML Prefilled Syringe Most dispensed

9,801 Medicaid prescriptions (Q1–Q4 2025) 80% of Glatiramer Injection prescriptions shown $39.9M gross reimbursement (before rebates) ≈ $4,067 per prescription (gross)

Summed across the 4 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1487361

1 ML glatiramer acetate 20 MG/ML Prefilled Syringe

2,417 Medicaid prescriptions (Q1–Q4 2025) 20% of Glatiramer Injection prescriptions shown $15.1M gross reimbursement (before rebates) ≈ $6,237 per prescription (gross)

Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1111641

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Glatiramer Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 31 listed Glatiramer Injection NDCs with Medicaid activity.

🔍 Compare Glatiramer Injection products

A representative set of FDA-listed product records for Glatiramer Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 43 of 43 products — FDA National Drug Code Directory. See every product, package size and price: browse all 43 Glatiramer Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Glatiramer Injection RxCUI 214582 2 dose forms · 3 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 375829 In current FDA listings
    Clinical drug / strength (SCD) acetate 20 MG/ML RxCUI 242276

Look up RxCUI 214582 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Copaxone Glatopa

🏭 Manufacturers & labelers

Sandoz Inc 10 Teva Neuroscience, Inc. 8 Bryant Ranch Prepack 6 Mylan Pharmaceuticals Inc. 6 Zydus Pharmaceuticals USA Inc. 4 Ajenat Pharmaceuticals Llc 2 Italfarmaco SpA 2 Sun Pharmaceutical Industries, Inc. 2 Upsher-smith Laboratories, Llc 2 Natco Pharma Limited 1

RxNorm drug class

Glatiramer Injection belongs to the Other immunostimulants class.

Drug family (ATC) Other immunostimulants

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 23, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Glatiramer Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Glatiramer Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
13
NDC products indexed
43
Distinct labelers/manufacturers represented
10
Linked representative label ⓘ
Teva Neuroscience, Inc.
Linked label effective
Jun 23, 2026
Composite sections available
21
Linked SPL Set ID
aa88f583-4f5f-433b-80b4-1f4c9fb28357
Linked SPL Document ID
11a58ba0-b865-49e6-86e3-eb9bb58341e5
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 13 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Teva Neuroscience, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.