Drug
Glatiramer
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Multiple Sclerosis | 514 | 46.4 | 51.8 | signal |
| 2 | Multiple Sclerosis Relapse | 465 | 29.1 | 32.0 | signal |
| 3 | Injection Site Mass | 186 | 21.8 | 22.6 | signal |
| 4 | Injection Site Induration | 64 | 21.3 | 21.6 | signal |
| 5 | Injection Site Urticaria | 70 | 12.4 | 12.6 | signal |
| 6 | Injection Site Reaction | 172 | 10.8 | 11.1 | signal |
| 7 | Injection Site Pruritus | 162 | 10.5 | 10.8 | signal |
| 8 | Injection Site Swelling | 183 | 10.4 | 10.8 | signal |
| 9 | Injection Site Discolouration | 29 | 10.1 | 10.1 | signal |
| 10 | Device Mechanical Issue | 29 | 9.7 | 9.7 | signal |
| 11 | Lymphopenia | 30 | 9.2 | 9.2 | signal |
| 12 | Product Substitution Issue | 112 | 8.4 | 8.5 | signal |
| 13 | Injection Site Erythema | 237 | 8.3 | 8.6 | signal |
| 14 | Central Nervous System Lesion | 26 | 8.1 | 8.1 | signal |
| 15 | Device Use Issue | 32 | 8.0 | 8.0 | signal |
| 16 | Injection Site Warmth | 38 | 7.9 | 8.0 | signal |
| 17 | Injection Site Irritation | 23 | 7.8 | 7.9 | signal |
| 18 | Maternal Exposure During Pregnancy | 146 | 7.1 | 7.3 | signal |
| 19 | Injection Site Nodule | 17 | 6.7 | 6.7 | signal |
| 20 | Hemiparesis | 26 | 6.6 | 6.6 | signal |
| 21 | Therapy Interrupted | 103 | 6.4 | 6.5 | signal |
| 22 | Injection Site Discomfort | 15 | 6.2 | 6.3 | signal |
| 23 | Injection Site Pain | 417 | 5.9 | 6.4 | signal |
| 24 | Injection Site Bruising | 108 | 5.9 | 6.0 | signal |
| 25 | Needle Issue | 39 | 5.9 | 5.9 | signal |
| 26 | Ataxia | 16 | 5.8 | 5.8 | signal |
| 27 | Muscle Spasticity | 16 | 5.5 | 5.6 | signal |
| 28 | Flushing | 131 | 5.5 | 5.6 | signal |
| 29 | Therapy Cessation | 62 | 5.2 | 5.3 | signal |
| 30 | Pharyngeal Swelling | 11 | 4.9 | 4.9 | signal |
| 31 | Bladder Disorder | 11 | 4.8 | 4.8 | signal |
| 32 | Abortion Induced | 10 | 4.6 | 4.6 | signal |
| 33 | Diplopia | 26 | 4.3 | 4.3 | signal |
| 34 | Skin Reaction | 14 | 4.3 | 4.3 | signal |
| 35 | Hypoaesthesia | 148 | 4.2 | 4.3 | signal |
| 36 | Injection Site Haemorrhage | 76 | 4.1 | 4.2 | signal |
| 37 | Paralysis | 13 | 3.9 | 3.9 | signal |
| 38 | Anaphylactic Shock | 23 | 3.9 | 3.9 | signal |
| 39 | Abortion Spontaneous | 36 | 3.8 | 3.9 | signal |
| 40 | Micturition Urgency | 10 | 3.8 | 3.8 | signal |
| 41 | Drug-induced Liver Injury | 27 | 3.8 | 3.8 | signal |
| 42 | Insurance Issue | 13 | 3.8 | 3.8 | signal |
| 43 | Hypoaesthesia Oral | 13 | 3.7 | 3.7 | signal |
| 44 | Aphasia | 26 | 3.7 | 3.7 | signal |
| 45 | Injection Site Rash | 26 | 3.7 | 3.7 | signal |
| 46 | Urinary Incontinence | 25 | 3.6 | 3.6 | signal |
| 47 | Cognitive Disorder | 39 | 3.6 | 3.6 | signal |
| 48 | Feeling Hot | 51 | 3.6 | 3.6 | signal |
| 49 | Chills | 97 | 3.5 | 3.6 | signal |
| 50 | Scar | 14 | 3.5 | 3.5 | signal |
| 51 | Limb Discomfort | 25 | 3.5 | 3.5 | signal |
| 52 | Sensory Disturbance | 13 | 3.5 | 3.5 | signal |
| 53 | Device Defective | 13 | 3.5 | 3.5 | signal |
| 54 | Anaphylactic Reaction | 44 | 3.4 | 3.5 | signal |
| 55 | Clostridium Difficile Colitis | 8 | 3.2 | 3.2 | signal |
| 56 | Cystitis | 24 | 3.2 | 3.2 | signal |
| 57 | Pregnancy | 15 | 3.2 | 3.2 | signal |
| 58 | Throat Tightness | 20 | 3.2 | 3.2 | signal |
| 59 | Muscular Weakness | 84 | 3.2 | 3.2 | signal |
| 60 | Hospitalisation | 111 | 3.1 | 3.2 | signal |
| 61 | Injection Site Extravasation | 9 | 3.1 | 3.1 | signal |
| 62 | Chest Discomfort | 73 | 3.1 | 3.1 | signal |
| 63 | Gait Inability | 23 | 3.0 | 3.0 | signal |
| 64 | Balance Disorder | 60 | 3.0 | 3.0 | signal |
| 65 | Temperature Intolerance | 7 | 2.9 | 2.9 | signal |
| 66 | Gait Disturbance | 129 | 2.9 | 2.9 | signal |
| 67 | Malignant Melanoma | 9 | 2.9 | 2.9 | signal |
| 68 | Device Issue | 58 | 2.9 | 2.9 | signal |
| 69 | Kidney Infection | 13 | 2.8 | 2.9 | signal |
| 70 | Mobility Decreased | 47 | 2.8 | 2.8 | signal |
| 71 | Brain Neoplasm | 6 | 2.8 | 2.8 | signal |
| 72 | Palpitations | 74 | 2.7 | 2.7 | signal |
| 73 | Head Discomfort | 11 | 2.7 | 2.7 | signal |
| 74 | Product Dose Omission | 41 | 2.7 | 2.7 | signal |
| 75 | Urticaria | 103 | 2.7 | 2.7 | signal |
| 76 | Inability To Afford Medication | 6 | 2.6 | 2.6 | signal |
| 77 | Feeling Cold | 17 | 2.6 | 2.6 | signal |
| 78 | Paraesthesia | 96 | 2.6 | 2.6 | signal |
| 79 | Hepatomegaly | 6 | 2.6 | 2.6 | signal |
| 80 | Therapy Non-responder | 27 | 2.6 | 2.6 | signal |
| 81 | Urinary Tract Infection | 102 | 2.6 | 2.6 | signal |
| 82 | Hypotonia | 6 | 2.6 | 2.6 | signal |
| 83 | Fall | 198 | 2.6 | 2.6 | signal |
| 84 | Accident | 7 | 2.5 | 2.5 | signal |
| 85 | Product Use Complaint | 9 | 2.5 | 2.5 | signal |
| 86 | Oral Pain | 13 | 2.5 | 2.5 | signal |
| 87 | Spinal Operation | 7 | 2.5 | 2.5 | signal |
| 88 | Syringe Issue | 10 | 2.5 | 2.5 | signal |
| 89 | Lymphocyte Count Decreased | 10 | 2.4 | 2.4 | signal |
| 90 | Covid-19 | 100 | 2.4 | 2.5 | signal |
| 91 | Breast Pain | 6 | 2.4 | 2.4 | no signal |
| 92 | Muscle Tightness | 9 | 2.4 | 2.4 | signal |
| 93 | Jaundice | 15 | 2.4 | 2.4 | signal |
| 94 | Incorrect Dose Administered By Device | 14 | 2.4 | 2.4 | signal |
| 95 | Loss Of Personal Independence In Daily Activities | 26 | 2.3 | 2.4 | signal |
| 96 | Product Dose Omission Issue | 155 | 2.3 | 2.4 | signal |
| 97 | Dysarthria | 20 | 2.3 | 2.3 | signal |
| 98 | Adverse Reaction | 7 | 2.3 | 2.3 | no signal |
| 99 | Mouth Ulceration | 11 | 2.2 | 2.2 | signal |
| 100 | Swelling Face | 34 | 2.2 | 2.3 | signal |
| 101 | Post Procedural Complication | 10 | 2.2 | 2.2 | signal |
| 102 | Lymphoma | 8 | 2.2 | 2.2 | signal |
| 103 | Ankle Fracture | 8 | 2.2 | 2.2 | signal |
| 104 | Blindness | 21 | 2.2 | 2.2 | signal |
| 105 | Vasculitis | 6 | 2.2 | 2.2 | no signal |
| 106 | Caesarean Section | 6 | 2.2 | 2.2 | no signal |
| 107 | Lymphadenopathy | 18 | 2.2 | 2.2 | signal |
| 108 | Cyanosis | 8 | 2.2 | 2.2 | no signal |
| 109 | Covid-19 Pneumonia | 6 | 2.2 | 2.2 | no signal |
| 110 | Nephrolithiasis | 23 | 2.2 | 2.2 | signal |
| 111 | Coordination Abnormal | 7 | 2.1 | 2.1 | no signal |
| 112 | Seizure | 57 | 2.1 | 2.1 | signal |
| 113 | Speech Disorder | 26 | 2.1 | 2.1 | signal |
| 114 | Movement Disorder | 16 | 2.1 | 2.1 | signal |
| 115 | Thyroid Cancer | 6 | 2.1 | 2.1 | no signal |
| 116 | Foetal Exposure During Pregnancy | 40 | 2.1 | 2.1 | signal |
| 117 | Generalised Tonic-clonic Seizure | 8 | 2.1 | 2.1 | no signal |
| 118 | Hypersensitivity | 90 | 2.1 | 2.1 | signal |
| 119 | Tremor | 80 | 2.1 | 2.1 | signal |
| 120 | Knee Arthroplasty | 10 | 2.1 | 2.1 | signal |
| 121 | Syncope | 48 | 2.1 | 2.1 | signal |
| 122 | Dysstasia | 14 | 2.1 | 2.1 | signal |
| 123 | Muscle Twitching | 11 | 2.0 | 2.0 | signal |
| 124 | Head Injury | 15 | 2.0 | 2.0 | signal |
| 125 | Burning Sensation | 33 | 2.0 | 2.0 | signal |
| 126 | Adverse Drug Reaction | 42 | 2.0 | 2.0 | signal |
| 127 | Memory Impairment | 64 | 2.0 | 2.0 | no signal |
| 128 | Skin Cancer | 10 | 2.0 | 2.0 | no signal |
| 129 | Visual Impairment | 57 | 2.0 | 2.0 | no signal |
| 130 | Surgery | 26 | 1.9 | 1.9 | no signal |
| 131 | Nerve Injury | 5 | 1.9 | 1.9 | no signal |
| 132 | Injury Associated With Device | 9 | 1.9 | 1.9 | no signal |
| 133 | Product Prescribing Issue | 9 | 1.9 | 1.9 | no signal |
| 134 | Status Epilepticus | 5 | 1.9 | 1.9 | no signal |
| 135 | Premature Delivery | 7 | 1.9 | 1.9 | no signal |
| 136 | Loss Of Consciousness | 55 | 1.8 | 1.9 | no signal |
| 137 | Spinal Pain | 5 | 1.8 | 1.8 | no signal |
| 138 | Blindness Unilateral | 6 | 1.8 | 1.8 | no signal |
| 139 | Posterior Reversible Encephalopathy Syndrome | 4 | 1.8 | 1.8 | no signal |
| 140 | Macular Degeneration | 5 | 1.8 | 1.8 | no signal |
| 141 | Hyperthyroidism | 6 | 1.8 | 1.8 | no signal |
| 142 | Mental Impairment | 10 | 1.8 | 1.8 | no signal |
| 143 | Pneumocystis Jirovecii Pneumonia | 4 | 1.7 | 1.7 | no signal |
| 144 | Influenza Like Illness | 33 | 1.7 | 1.7 | no signal |
| 145 | Device Difficult To Use | 26 | 1.7 | 1.7 | no signal |
| 146 | Device Breakage | 15 | 1.6 | 1.6 | no signal |
| 147 | Erythema | 77 | 1.6 | 1.6 | no signal |
| 148 | Neoplasm Malignant | 25 | 1.6 | 1.6 | no signal |
| 149 | Sars-cov-2 Test Positive | 5 | 1.6 | 1.6 | no signal |
| 150 | Musculoskeletal Disorder | 7 | 1.6 | 1.6 | no signal |
| 151 | Cerebral Haemorrhage | 13 | 1.6 | 1.6 | no signal |
| 152 | Oral Herpes | 7 | 1.5 | 1.5 | no signal |
| 153 | Disease Progression | 42 | 1.5 | 1.5 | no signal |
| 154 | Sexual Dysfunction | 4 | 1.5 | 1.5 | no signal |
| 155 | Injection Site Haematoma | 5 | 1.5 | 1.5 | no signal |
| 156 | Product Dose Omission In Error | 9 | 1.4 | 1.4 | no signal |
| 157 | Hot Flush | 25 | 1.4 | 1.4 | no signal |
| 158 | Premature Baby | 10 | 1.4 | 1.4 | no signal |
| 159 | Device Leakage | 14 | 1.4 | 1.4 | no signal |
| 160 | Device Failure | 5 | 1.4 | 1.4 | no signal |
| 161 | Hip Arthroplasty | 5 | 1.4 | 1.4 | no signal |
| 162 | Device Malfunction | 22 | 1.4 | 1.4 | no signal |
| 163 | Product Packaging Issue | 3 | 1.4 | 1.4 | no signal |
| 164 | Thinking Abnormal | 6 | 1.4 | 1.4 | no signal |
| 165 | Increased Appetite | 6 | 1.4 | 1.4 | no signal |
| 166 | Pruritus Generalised | 7 | 1.4 | 1.4 | no signal |
| 167 | Disease Recurrence | 15 | 1.4 | 1.4 | no signal |
| 168 | Drug Resistance | 8 | 1.3 | 1.3 | no signal |
| 169 | Tuberculosis | 4 | 1.3 | 1.3 | no signal |
| 170 | Affect Lability | 3 | 1.3 | 1.3 | no signal |
| 171 | Decreased Immune Responsiveness | 3 | 1.3 | 1.3 | no signal |
| 172 | Skin Irritation | 14 | 1.3 | 1.3 | no signal |
| 173 | Inflammatory Bowel Disease | 3 | 1.3 | 1.3 | no signal |
| 174 | Vaginal Discharge | 3 | 1.3 | 1.3 | no signal |
| 175 | Ovarian Cyst | 3 | 1.3 | 1.3 | no signal |
| 176 | Angioedema | 13 | 1.3 | 1.3 | no signal |
| 177 | Wrong Technique In Product Usage Process | 59 | 1.3 | 1.3 | no signal |
| 178 | Drug Exposure During Pregnancy | 10 | 1.2 | 1.2 | no signal |
| 179 | Metastases To Liver | 5 | 1.2 | 1.2 | no signal |
| 180 | Drug Effect Less Than Expected | 4 | 1.2 | 1.2 | no signal |
| 181 | Exposure During Pregnancy | 17 | 1.2 | 1.2 | no signal |
| 182 | Product Availability Issue | 6 | 1.1 | 1.1 | no signal |
| 183 | Incorrect Product Administration Duration | 5 | 1.1 | 1.1 | no signal |
| 184 | Breast Cancer | 23 | 1.1 | 1.1 | no signal |
| 185 | Ankylosing Spondylitis | 3 | 1.0 | 1.0 | no signal |
| 186 | Product Dispensing Error | 5 | 1.0 | 1.0 | no signal |
| 187 | Incorrect Dose Administered | 51 | 1.0 | 1.0 | no signal |
| 188 | Colitis Ulcerative | 10 | 1.0 | 1.0 | no signal |
| 189 | Circumstance Or Information Capable Of Leading To Medication Error | 7 | 0.9 | 0.9 | no signal |
| 190 | Device Delivery System Issue | 5 | 0.8 | 0.8 | no signal |
| 191 | Product Quality Issue | 25 | 0.8 | 0.8 | no signal |
| 192 | Product Storage Error | 16 | 0.8 | 0.8 | no signal |
| 193 | Amenorrhoea | 3 | 0.8 | 0.8 | no signal |
| 194 | Wrong Technique In Device Usage Process | 8 | 0.8 | 0.8 | no signal |
| 195 | Product Administered At Inappropriate Site | 3 | 0.7 | 0.7 | no signal |
| 196 | Drug Effective For Unapproved Indication | 4 | 0.6 | 0.6 | no signal |
| 197 | Drug Dose Omission By Device | 7 | 0.4 | 0.4 | no signal |
| 198 | Accidental Exposure To Product | 9 | 0.4 | 0.4 | no signal |
| 199 | Device Use Error | 3 | 0.4 | 0.4 | no signal |
| 200 | Renal Cancer | 4 | 0.4 | 0.4 | no signal |