Glatiramer side effects: what 4,883 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Glatiramer Acetate
Who reports
4,883 reports · 73% serious · 177 with death outcome · 78% female
Used for
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatiramer acetate inj.
What it is
Glatiramer acetate, the active ingredient of glatiramer acetate injection, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively.
Boxed warning
ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 160 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Multiple sclerosis | 514 | 46.4 42.7–50.4ROR 51.8 · χ² 22,597 / p <1e-300 | 45.8 EB05 42.6 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 52.2 | no trial data cached |
| Multiple sclerosis relapse | 465 | 29.1 26.7–31.7ROR 32.0 · χ² 12,534 / p <1e-300 | 28.9 EB05 26.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 30.9 | no trial data cached |
| Injection site mass | 186 | 21.8 18.9–25.1ROR 22.6 · χ² 3,653 / p <1e-300 | 21.6 EB05 19.1 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 70.2 · 86% consumer | no trial data cached |
| Injection site induration | 64 | 21.3 16.7–27.2ROR 21.6 · χ² 1,213 / p 5e-266 | 21.1 EB05 17.1 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=51 | no trial data cached |
| Injection site urticaria | 70 | 12.4 9.8–15.7ROR 12.6 · χ² 723 / p 2e-159 | 12.2 EB05 9.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=41 · 77% consumer | no trial data cached |
| Injection site reaction | 172 | 10.8 9.3–12.5ROR 11.1 · χ² 1,519 / p <1e-300 | 10.7 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 25.2 | no trial data cached |
| Injection site pruritus | 162 | 10.5 9.0–12.2ROR 10.8 · χ² 1,380 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 41.8 | no trial data cached |
| Injection site swelling | 183 | 10.4 9.0–12.0ROR 10.8 · χ² 1,546 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 38.6 | no trial data cached |
| Injection site discolouration | 29 | 10.1 7.0–14.5ROR 10.1 · χ² 227 / p 1e-51 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 76% consumer | no trial data cached |
| Device mechanical issue | 29 | 9.7 6.7–13.9ROR 9.7 · χ² 216 / p 3e-49 | 8.9 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=14 · 93% consumer | no trial data cached |
| Lymphopenia | 30 | 9.2 6.4–13.1ROR 9.2 · χ² 210 / p 7e-48 | 8.5 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 97% clinician | no trial data cached |
| Product substitution issue | 112 | 8.4 7.0–10.1ROR 8.5 · χ² 720 / p 6e-159 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Injection site erythema (redness where injected) | 237 | 8.3 7.3–9.4ROR 8.6 · χ² 1,511 / p <1e-300 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.1 | no trial data cached |
| Central nervous system lesion | 26 | 8.1 5.5–11.9ROR 8.1 · χ² 154 / p 1e-35 | 7.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Device use issue | 32 | 8.0 5.6–11.2ROR 8.0 · χ² 187 / p 6e-43 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=19 · 94% consumer | no trial data cached |
| Injection site warmth | 38 | 7.9 5.8–10.9ROR 8.0 · χ² 223 / p 9e-51 | 7.4 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · 71% consumer | no trial data cached |
| Injection site irritation | 23 | 7.8 5.2–11.8ROR 7.9 · χ² 130 / p 2e-30 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Maternal exposure during pregnancy | 146 | 7.1 6.1–8.4ROR 7.3 · χ² 764 / p 2e-168 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · ♀ 100% (drug 78%) | no trial data cached |
| Injection site nodule | 17 | 6.7 4.1–10.7ROR 6.7 · χ² 76 / p 1e-18 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Hemiparesis | 26 | 6.6 4.5–9.6ROR 6.6 · χ² 117 / p 2e-27 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Therapy interrupted | 103 | 6.4 5.3–7.8ROR 6.5 · χ² 467 / p 9e-104 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 | no trial data cached |
| Injection site discomfort | 15 | 6.2 3.8–10.4ROR 6.3 · χ² 61 / p 3e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Injection site pain (pain where injected) | 417 | 5.9 5.4–6.5ROR 6.4 · χ² 1,717 / p <1e-300 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 21.7 | no trial data cached |
| Injection site bruising | 108 | 5.9 4.9–7.1ROR 6.0 · χ² 434 / p 9e-97 | 5.7 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.1 · 77% consumer | no trial data cached |
| Needle issue | 39 | 5.9 4.3–8.0ROR 5.9 · χ² 152 / p 3e-35 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=18 · 92% consumer | no trial data cached |
| Ataxia | 16 | 5.8 3.5–9.4ROR 5.8 · χ² 58 / p 1e-14 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Muscle spasticity | 16 | 5.5 3.4–9.0ROR 5.6 · χ² 55 / p 6e-14 | 4.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Flushing | 131 | 5.5 4.7–6.5ROR 5.6 · χ² 481 / p 5e-107 | 5.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.9 | no trial data cached |
| Therapy cessation | 62 | 5.2 4.1–6.7ROR 5.3 · χ² 207 / p 3e-47 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Pharyngeal swelling | 11 | 4.9 2.7–8.9ROR 4.9 · χ² 31 / p 2e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Bladder disorder | 11 | 4.8 2.6–8.6ROR 4.8 · χ² 29 / p 4e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Abortion induced | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Diplopia (double vision) | 26 | 4.3 2.9–6.3ROR 4.3 · χ² 63 / p 1e-15 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Skin reaction | 14 | 4.3 2.5–7.2ROR 4.3 · χ² 32 / p 8e-9 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Hypoaesthesia (numbness) | 148 | 4.2 3.6–5.0ROR 4.3 · χ² 366 / p 7e-82 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Injection site haemorrhage | 76 | 4.1 3.3–5.1ROR 4.2 · χ² 177 / p 1e-40 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.4 · 83% consumer | no trial data cached |
| Paralysis | 13 | 3.9 2.3–6.7ROR 3.9 · χ² 25 / p 3e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Anaphylactic shock | 23 | 3.9 2.6–5.8ROR 3.9 · χ² 46 / p 6e-12 | 3.6 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Abortion spontaneous | 36 | 3.8 2.8–5.3ROR 3.9 · χ² 73 / p 6e-18 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · ♀ 100% (drug 78%) | no trial data cached |
| Micturition urgency | 10 | 3.8 2.0–7.0ROR 3.8 · χ² 18 / p 1e-5 | 3.3 EB05 2.0 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Multiple sclerosis | 514 | 46.4 42.7–50.4ROR 51.8 · χ² 22,597 / p <1e-300 | 45.8 EB05 42.6 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 52.2 | no trial data cached |
| Multiple sclerosis relapse | 465 | 29.1 26.7–31.7ROR 32.0 · χ² 12,534 / p <1e-300 | 28.9 EB05 26.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 30.9 | no trial data cached |
| Injection site pain (pain where injected) | 417 | 5.9 5.4–6.5ROR 6.4 · χ² 1,717 / p <1e-300 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 21.7 | no trial data cached |
| Injection site erythema (redness where injected) | 237 | 8.3 7.3–9.4ROR 8.6 · χ² 1,511 / p <1e-300 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.1 | no trial data cached |
| Fall | 198 | 2.6 2.2–2.9ROR 2.6 · χ² 189 / p 2e-43 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Injection site mass | 186 | 21.8 18.9–25.1ROR 22.6 · χ² 3,653 / p <1e-300 | 21.6 EB05 19.1 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 70.2 · 86% consumer | no trial data cached |
| Injection site swelling | 183 | 10.4 9.0–12.0ROR 10.8 · χ² 1,546 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 38.6 | no trial data cached |
| Injection site reaction | 172 | 10.8 9.3–12.5ROR 11.1 · χ² 1,519 / p <1e-300 | 10.7 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 25.2 | no trial data cached |
| Injection site pruritus | 162 | 10.5 9.0–12.2ROR 10.8 · χ² 1,380 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 41.8 | no trial data cached |
| Product dose omission issue | 155 | 2.3 2.0–2.7ROR 2.4 · χ² 119 / p 5e-28 | 2.3 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 84% consumer | no trial data cached |
| Hypoaesthesia (numbness) | 148 | 4.2 3.6–5.0ROR 4.3 · χ² 366 / p 7e-82 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Maternal exposure during pregnancy | 146 | 7.1 6.1–8.4ROR 7.3 · χ² 764 / p 2e-168 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · ♀ 100% (drug 78%) | no trial data cached |
| Flushing | 131 | 5.5 4.7–6.5ROR 5.6 · χ² 481 / p 5e-107 | 5.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.9 | no trial data cached |
| Gait disturbance | 129 | 2.9 2.4–3.4ROR 2.9 · χ² 159 / p 1e-36 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 71% consumer | no trial data cached |
| Product substitution issue | 112 | 8.4 7.0–10.1ROR 8.5 · χ² 720 / p 6e-159 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Lymphopenia — n=30, PRR 9.2
- Central nervous system lesion — n=26, PRR 8.1
- Hemiparesis — n=26, PRR 6.6
- Needle issue — n=39, PRR 5.9
- Hypoaesthesia — n=148, PRR 4.2
- Anaphylactic shock — n=23, PRR 3.9
- Abortion spontaneous — n=36, PRR 3.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Glatiramer?
In FDA FAERS, the most frequently co-reported reaction terms for Glatiramer are multiple sclerosis, multiple sclerosis relapse, injection site pain, injection site erythema, fall, injection site mass. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Glatiramer have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy.
Do FAERS signals prove that Glatiramer causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 456a34c7-8511-4000-99a7-ad8f8de6d35e, effective 20250207; matched on
openfda.generic_name.exact:"GLATIRAMER") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 200 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.