Drug
Dimethyl Fumarate Kit
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 | Lymphopenia | 80 | 36.4 | 37.3 | signal |
| 2 | Flushing | 326 | 20.4 | 22.5 | signal |
| 3 | Multiple Sclerosis | 151 | 20.0 | 21.0 | signal |
| 4 | Multiple Sclerosis Relapse | 217 | 20.0 | 21.4 | signal |
| 5 | Central Nervous System Lesion | 37 | 17.1 | 17.2 | signal |
| 6 | Muscle Spasticity | 27 | 13.9 | 14.0 | signal |
| 7 | Rebound Effect | 23 | 12.9 | 13.0 | signal |
| 8 | Lymphocyte Count Decreased | 31 | 11.2 | 11.3 | signal |
| 9 | Therapy Interrupted | 114 | 10.5 | 10.9 | signal |
| 10 | Ataxia | 19 | 10.2 | 10.2 | signal |
| 11 | Product Substitution Issue | 87 | 9.6 | 9.9 | signal |
| 12 | Micturition Urgency | 17 | 9.6 | 9.6 | signal |
| 13 | Eosinophilia | 21 | 7.7 | 7.7 | signal |
| 14 | Hemiparesis | 19 | 7.1 | 7.1 | signal |
| 15 | Sensory Disturbance | 17 | 6.7 | 6.7 | signal |
| 16 | Spinal Disorder | 9 | 6.0 | 6.1 | signal |
| 17 | Therapy Cessation | 48 | 6.0 | 6.1 | signal |
| 18 | Temperature Intolerance | 9 | 5.6 | 5.6 | signal |
| 19 | Incontinence | 9 | 5.4 | 5.4 | signal |
| 20 | Bedridden | 11 | 5.3 | 5.3 | signal |
| 21 | Therapy Change | 8 | 5.3 | 5.3 | signal |
| 22 | Neuralgia | 20 | 5.2 | 5.3 | signal |
| 23 | Bladder Disorder | 8 | 5.1 | 5.1 | signal |
| 24 | Balance Disorder | 69 | 5.1 | 5.2 | signal |
| 25 | Gastrointestinal Disorder | 68 | 4.9 | 5.0 | signal |
| 26 | Urosepsis | 7 | 4.8 | 4.8 | signal |
| 27 | Generalised Tonic-clonic Seizure | 12 | 4.7 | 4.7 | signal |
| 28 | Diplopia | 19 | 4.7 | 4.7 | signal |
| 29 | Oral Herpes | 14 | 4.6 | 4.6 | signal |
| 30 | Lower Limb Fracture | 13 | 4.3 | 4.3 | signal |
| 31 | Renal Pain | 7 | 4.2 | 4.2 | signal |
| 32 | Irritable Bowel Syndrome | 14 | 4.2 | 4.2 | signal |
| 33 | Upper Limb Fracture | 13 | 4.1 | 4.1 | signal |
| 34 | Ankle Fracture | 10 | 4.1 | 4.1 | signal |
| 35 | Basal Cell Carcinoma | 10 | 4.1 | 4.1 | signal |
| 36 | Fall | 212 | 4.1 | 4.3 | signal |
| 37 | Gait Disturbance | 118 | 3.9 | 4.0 | signal |
| 38 | Leukocytosis | 11 | 3.9 | 3.9 | signal |
| 39 | Leukopenia | 30 | 3.8 | 3.9 | signal |
| 40 | Brain Injury | 6 | 3.8 | 3.8 | signal |
| 41 | Cystitis | 19 | 3.8 | 3.8 | signal |
| 42 | Rib Fracture | 12 | 3.7 | 3.7 | signal |
| 43 | Hot Flush | 44 | 3.7 | 3.8 | signal |
| 44 | Spinal Operation | 7 | 3.7 | 3.7 | signal |
| 45 | Covid-19 | 100 | 3.6 | 3.7 | signal |
| 46 | Movement Disorder | 18 | 3.6 | 3.6 | signal |
| 47 | Burning Sensation | 39 | 3.5 | 3.6 | signal |
| 48 | Gastroenteritis | 8 | 3.5 | 3.5 | signal |
| 49 | Status Epilepticus | 6 | 3.4 | 3.4 | signal |
| 50 | Leukaemia | 5 | 3.4 | 3.4 | signal |
| 51 | Urinary Tract Infection | 87 | 3.3 | 3.3 | signal |
| 52 | Disease Recurrence | 24 | 3.2 | 3.2 | signal |
| 53 | Wrist Fracture | 6 | 3.2 | 3.2 | signal |
| 54 | Drug-induced Liver Injury | 15 | 3.1 | 3.1 | signal |
| 55 | Myelodysplastic Syndrome | 7 | 3.1 | 3.1 | signal |
| 56 | Abdominal Pain Upper | 99 | 3.1 | 3.1 | signal |
| 57 | Brain Fog | 7 | 3.1 | 3.1 | signal |
| 58 | Intentional Dose Omission | 13 | 3.0 | 3.0 | signal |
| 59 | Cognitive Disorder | 22 | 3.0 | 3.0 | signal |
| 60 | Kidney Infection | 9 | 2.9 | 2.9 | signal |
| 61 | Pulmonary Thrombosis | 5 | 2.9 | 2.9 | signal |
| 62 | Paraesthesia | 72 | 2.9 | 2.9 | signal |
| 63 | Localised Infection | 11 | 2.9 | 2.9 | signal |
| 64 | Dysstasia | 13 | 2.8 | 2.8 | signal |
| 65 | Hip Fracture | 14 | 2.8 | 2.8 | signal |
| 66 | Coordination Abnormal | 6 | 2.7 | 2.7 | signal |
| 67 | Psoriatic Arthropathy | 17 | 2.7 | 2.7 | signal |
| 68 | Pharyngeal Swelling | 4 | 2.7 | 2.7 | no signal |
| 69 | Hypokinesia | 6 | 2.6 | 2.6 | signal |
| 70 | Thyroid Cancer | 5 | 2.6 | 2.6 | no signal |
| 71 | Abortion Spontaneous | 16 | 2.5 | 2.5 | signal |
| 72 | Sluggishness | 4 | 2.5 | 2.5 | no signal |
| 73 | Breast Cancer | 37 | 2.5 | 2.5 | signal |
| 74 | Folliculitis | 4 | 2.5 | 2.5 | no signal |
| 75 | Dermatitis | 8 | 2.5 | 2.5 | signal |
| 76 | Sars-cov-2 Test Positive | 5 | 2.4 | 2.4 | no signal |
| 77 | Malignant Melanoma | 5 | 2.4 | 2.4 | no signal |
| 78 | Product Dose Omission In Error | 10 | 2.4 | 2.4 | signal |
| 79 | Abasia | 9 | 2.3 | 2.3 | signal |
| 80 | Cholecystectomy | 4 | 2.2 | 2.2 | no signal |
| 81 | Spinal Fracture | 7 | 2.2 | 2.2 | no signal |
| 82 | Neoplasm | 4 | 2.2 | 2.2 | no signal |
| 83 | Synovitis | 6 | 2.1 | 2.1 | no signal |
| 84 | Ovarian Cancer | 3 | 2.1 | 2.1 | no signal |
| 85 | Thinking Abnormal | 6 | 2.0 | 2.0 | no signal |
| 86 | Increased Appetite | 6 | 2.0 | 2.0 | no signal |
| 87 | Influenza Like Illness | 26 | 2.0 | 2.0 | signal |
| 88 | Adverse Reaction | 4 | 1.9 | 1.9 | no signal |
| 89 | Cytomegalovirus Infection | 5 | 1.9 | 1.9 | no signal |
| 90 | Helicobacter Infection | 3 | 1.9 | 1.9 | no signal |
| 91 | Skin Burning Sensation | 20 | 1.8 | 1.8 | no signal |
| 92 | Gastric Disorder | 9 | 1.6 | 1.6 | no signal |
| 93 | Sexual Dysfunction | 3 | 1.6 | 1.6 | no signal |
| 94 | Extra Dose Administered | 10 | 1.6 | 1.6 | no signal |
| 95 | Premature Delivery | 4 | 1.6 | 1.6 | no signal |
| 96 | Exposure During Pregnancy | 15 | 1.5 | 1.5 | no signal |
| 97 | Uveitis | 3 | 1.4 | 1.4 | no signal |
| 98 | Menorrhagia | 4 | 1.3 | 1.3 | no signal |
| 99 | Product Physical Issue | 4 | 1.3 | 1.3 | no signal |
| 100 | Psoriasis | 22 | 1.1 | 1.1 | no signal |
| 101 | Hepatic Cancer | 4 | 1.0 | 1.0 | no signal |
| 102 | Breast Cancer Female | 4 | 0.9 | 0.9 | no signal |
| 103 | Injection Site Reaction | 10 | 0.9 | 0.9 | no signal |
| 104 | Injection Site Urticaria | 3 | 0.8 | 0.8 | no signal |
| 105 | Prostate Cancer | 6 | 0.5 | 0.5 | no signal |
| 106 | Bladder Cancer | 4 | 0.4 | 0.4 | no signal |