Drug
Fingolimod Hydrochloride
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 | 475 | 148.7 | 164.4 | signal |
| 2 | Lymphocyte Count Decreased | 195 | 47.4 | 49.3 | signal |
| 3 | Multiple Sclerosis Relapse | 597 | 37.1 | 42.0 | signal |
| 4 | Rebound Effect | 97 | 36.7 | 37.4 | signal |
| 5 | Multiple Sclerosis | 330 | 29.4 | 31.4 | signal |
| 6 | Central Nervous System Lesion | 94 | 29.1 | 29.7 | signal |
| 7 | Ataxia | 55 | 19.7 | 19.9 | signal |
| 8 | Decreased Immune Responsiveness | 42 | 18.4 | 18.5 | signal |
| 9 | Hemiparesis | 71 | 17.8 | 18.0 | signal |
| 10 | Basal Cell Carcinoma | 62 | 17.0 | 17.2 | signal |
| 11 | Gamma-glutamyltransferase Increased | 63 | 12.1 | 12.3 | signal |
| 12 | Malignant Melanoma | 37 | 11.8 | 11.8 | signal |
| 13 | Sensory Disturbance | 42 | 11.1 | 11.2 | signal |
| 14 | Immunodeficiency | 38 | 11.0 | 11.1 | signal |
| 15 | Covid-19 Pneumonia | 28 | 10.0 | 10.1 | signal |
| 16 | Squamous Cell Carcinoma | 22 | 10.0 | 10.0 | signal |
| 17 | Coordination Abnormal | 32 | 9.7 | 9.8 | signal |
| 18 | Micturition Urgency | 25 | 9.4 | 9.4 | signal |
| 19 | Muscle Spasticity | 24 | 8.2 | 8.3 | signal |
| 20 | Paralysis | 27 | 8.0 | 8.0 | signal |
| 21 | Motor Dysfunction | 18 | 7.6 | 7.6 | signal |
| 22 | Ligament Sprain | 16 | 6.9 | 6.9 | signal |
| 23 | Aphasia | 47 | 6.6 | 6.7 | signal |
| 24 | Skin Cancer | 32 | 6.3 | 6.4 | signal |
| 25 | Skin Lesion | 37 | 5.8 | 5.8 | signal |
| 26 | Disease Recurrence | 61 | 5.4 | 5.5 | signal |
| 27 | Leukopenia | 63 | 5.4 | 5.4 | signal |
| 28 | Hyperbilirubinaemia | 13 | 5.4 | 5.4 | signal |
| 29 | Status Epilepticus | 14 | 5.3 | 5.3 | signal |
| 30 | Lymphoma | 19 | 5.2 | 5.2 | signal |
| 31 | Gastrointestinal Carcinoma | 11 | 5.1 | 5.1 | signal |
| 32 | Urosepsis | 11 | 5.1 | 5.1 | signal |
| 33 | Ovarian Cancer | 11 | 5.1 | 5.1 | signal |
| 34 | Neutrophil Count Increased | 12 | 5.0 | 5.0 | signal |
| 35 | Glomerular Filtration Rate Decreased | 14 | 4.9 | 4.9 | signal |
| 36 | Bladder Disorder | 11 | 4.7 | 4.7 | signal |
| 37 | Diarrhoea Haemorrhagic | 10 | 4.5 | 4.6 | signal |
| 38 | Hypoaesthesia | 157 | 4.5 | 4.6 | signal |
| 39 | Incontinence | 11 | 4.4 | 4.4 | signal |
| 40 | Vasculitis | 12 | 4.4 | 4.4 | signal |
| 41 | Cognitive Disorder | 47 | 4.3 | 4.3 | signal |
| 42 | Cystitis | 32 | 4.3 | 4.3 | signal |
| 43 | Muscle Tightness | 16 | 4.2 | 4.2 | signal |
| 44 | Temperature Intolerance | 10 | 4.2 | 4.2 | signal |
| 45 | Covid-19 | 172 | 4.1 | 4.3 | signal |
| 46 | Personality Change | 9 | 4.1 | 4.1 | signal |
| 47 | Diplopia | 25 | 4.1 | 4.1 | signal |
| 48 | Alanine Aminotransferase Increased | 59 | 4.1 | 4.1 | signal |
| 49 | Dysarthria | 36 | 4.1 | 4.1 | signal |
| 50 | Sinus Bradycardia | 9 | 4.0 | 4.0 | signal |
| 51 | Oral Candidiasis | 12 | 3.9 | 3.9 | signal |
| 52 | Herpes Zoster | 53 | 3.9 | 4.0 | signal |
| 53 | Dysuria | 33 | 3.8 | 3.8 | signal |
| 54 | Balance Disorder | 77 | 3.8 | 3.8 | signal |
| 55 | Bradycardia | 47 | 3.8 | 3.8 | signal |
| 56 | Pneumonia Aspiration | 22 | 3.8 | 3.8 | signal |
| 57 | Urinary Retention | 29 | 3.7 | 3.7 | signal |
| 58 | Blood Test Abnormal | 12 | 3.6 | 3.6 | signal |
| 59 | Exposure During Pregnancy | 53 | 3.6 | 3.7 | signal |
| 60 | Gait Disturbance | 161 | 3.6 | 3.7 | signal |
| 61 | Osteomyelitis | 15 | 3.5 | 3.5 | signal |
| 62 | Muscular Weakness | 94 | 3.5 | 3.6 | signal |
| 63 | Breast Cancer | 77 | 3.5 | 3.5 | signal |
| 64 | Product Substitution Issue | 47 | 3.5 | 3.5 | signal |
| 65 | Kidney Infection | 16 | 3.5 | 3.5 | signal |
| 66 | Foetal Exposure During Pregnancy | 66 | 3.5 | 3.5 | signal |
| 67 | Prescribed Underdose | 16 | 3.4 | 3.4 | signal |
| 68 | Gait Inability | 26 | 3.3 | 3.4 | signal |
| 69 | Urinary Incontinence | 23 | 3.3 | 3.3 | signal |
| 70 | Clostridium Difficile Colitis | 8 | 3.2 | 3.2 | signal |
| 71 | Premature Delivery | 12 | 3.2 | 3.2 | signal |
| 72 | Thyroid Cancer | 9 | 3.2 | 3.2 | signal |
| 73 | Paraesthesia | 117 | 3.2 | 3.2 | signal |
| 74 | Hepatic Enzyme Increased | 50 | 3.1 | 3.2 | signal |
| 75 | Hepatotoxicity | 16 | 3.1 | 3.1 | signal |
| 76 | Disease Progression | 84 | 3.0 | 3.1 | signal |
| 77 | Blood Pressure Fluctuation | 17 | 3.0 | 3.0 | signal |
| 78 | Hypokinesia | 10 | 2.9 | 2.9 | signal |
| 79 | Immune System Disorder | 9 | 2.9 | 2.9 | signal |
| 80 | Liver Function Test Abnormal | 20 | 2.9 | 2.9 | signal |
| 81 | Visual Impairment | 84 | 2.9 | 2.9 | signal |
| 82 | Heart Rate Decreased | 24 | 2.9 | 2.9 | signal |
| 83 | Limb Discomfort | 21 | 2.9 | 2.9 | signal |
| 84 | Aspartate Aminotransferase Increased | 36 | 2.9 | 2.9 | signal |
| 85 | Lymphadenopathy | 24 | 2.9 | 2.9 | signal |
| 86 | Generalised Tonic-clonic Seizure | 11 | 2.9 | 2.9 | signal |
| 87 | Heart Rate Irregular | 15 | 2.8 | 2.8 | signal |
| 88 | Drug Intolerance | 63 | 2.8 | 2.8 | signal |
| 89 | White Blood Cell Count Decreased | 71 | 2.8 | 2.8 | signal |
| 90 | Stress | 47 | 2.8 | 2.8 | signal |
| 91 | Intervertebral Disc Protrusion | 14 | 2.7 | 2.7 | signal |
| 92 | Myelodysplastic Syndrome | 9 | 2.6 | 2.6 | signal |
| 93 | Metastases To Bone | 10 | 2.6 | 2.6 | signal |
| 94 | Pulmonary Mass | 9 | 2.6 | 2.6 | signal |
| 95 | Amenorrhoea | 10 | 2.5 | 2.6 | signal |
| 96 | Sars-cov-2 Test Positive | 8 | 2.5 | 2.6 | signal |
| 97 | Hypoaesthesia Oral | 9 | 2.5 | 2.5 | signal |
| 98 | Treatment Failure | 48 | 2.5 | 2.5 | signal |
| 99 | Drug-induced Liver Injury | 18 | 2.5 | 2.5 | signal |
| 100 | Therapy Non-responder | 26 | 2.5 | 2.5 | signal |
| 101 | Musculoskeletal Chest Pain | 9 | 2.5 | 2.5 | signal |
| 102 | Ejection Fraction Decreased | 9 | 2.5 | 2.5 | signal |
| 103 | Petechiae | 6 | 2.5 | 2.5 | no signal |
| 104 | Hepatitis C | 7 | 2.4 | 2.4 | signal |
| 105 | Encephalopathy | 14 | 2.4 | 2.4 | signal |
| 106 | Urinary Tract Infection | 97 | 2.4 | 2.5 | signal |
| 107 | Skin Reaction | 8 | 2.4 | 2.4 | signal |
| 108 | Head Discomfort | 10 | 2.4 | 2.4 | signal |
| 109 | Eye Pain | 31 | 2.4 | 2.4 | signal |
| 110 | Paraesthesia Oral | 8 | 2.4 | 2.4 | signal |
| 111 | Haematuria | 19 | 2.4 | 2.4 | signal |
| 112 | Gastroenteritis | 8 | 2.3 | 2.3 | signal |
| 113 | Abortion Spontaneous | 22 | 2.3 | 2.3 | signal |
| 114 | Nervous System Disorder | 17 | 2.3 | 2.3 | signal |
| 115 | Vertigo | 33 | 2.3 | 2.3 | signal |
| 116 | Product Availability Issue | 12 | 2.3 | 2.3 | signal |
| 117 | Spinal Disorder | 5 | 2.2 | 2.2 | no signal |
| 118 | Vision Blurred | 71 | 2.2 | 2.2 | signal |
| 119 | Hepatitis | 13 | 2.2 | 2.2 | signal |
| 120 | Pollakiuria | 21 | 2.1 | 2.2 | signal |
| 121 | Premature Baby | 15 | 2.1 | 2.1 | signal |
| 122 | Pain Of Skin | 13 | 2.0 | 2.1 | signal |
| 123 | Cytomegalovirus Infection | 8 | 2.0 | 2.0 | no signal |
| 124 | Visual Acuity Reduced | 16 | 2.0 | 2.0 | signal |
| 125 | Maternal Exposure During Pregnancy | 42 | 2.0 | 2.0 | signal |
| 126 | Cardiovascular Disorder | 12 | 2.0 | 2.0 | no signal |
| 127 | Metastases To Central Nervous System | 6 | 2.0 | 2.0 | no signal |
| 128 | Movement Disorder | 15 | 2.0 | 2.0 | no signal |
| 129 | Lower Respiratory Tract Infection | 21 | 2.0 | 2.0 | no signal |
| 130 | Oral Herpes | 9 | 2.0 | 2.0 | no signal |
| 131 | Disturbance In Attention | 25 | 2.0 | 2.0 | no signal |
| 132 | Thyroid Disorder | 7 | 1.9 | 1.9 | no signal |
| 133 | Adverse Reaction | 6 | 1.9 | 1.9 | no signal |
| 134 | Influenza Like Illness | 37 | 1.9 | 1.9 | no signal |
| 135 | Brain Neoplasm | 4 | 1.9 | 1.9 | no signal |
| 136 | Neoplasm Malignant | 29 | 1.8 | 1.9 | no signal |
| 137 | Haematotoxicity | 4 | 1.8 | 1.8 | no signal |
| 138 | Memory Impairment | 59 | 1.8 | 1.8 | no signal |
| 139 | Mass | 6 | 1.8 | 1.8 | no signal |
| 140 | Impaired Healing | 14 | 1.8 | 1.8 | no signal |
| 141 | Withdrawal Syndrome | 18 | 1.8 | 1.8 | no signal |
| 142 | Product Prescribing Error | 10 | 1.8 | 1.8 | no signal |
| 143 | Feeling Jittery | 8 | 1.8 | 1.8 | no signal |
| 144 | Hyperthyroidism | 6 | 1.8 | 1.8 | no signal |
| 145 | Vitreous Floaters | 4 | 1.7 | 1.7 | no signal |
| 146 | Injection Site Discolouration | 5 | 1.7 | 1.7 | no signal |
| 147 | Cyst | 5 | 1.7 | 1.7 | no signal |
| 148 | Extra Dose Administered | 16 | 1.7 | 1.7 | no signal |
| 149 | Speech Disorder | 21 | 1.7 | 1.7 | no signal |
| 150 | Eye Disorder | 13 | 1.7 | 1.7 | no signal |
| 151 | Tuberculosis | 5 | 1.7 | 1.7 | no signal |
| 152 | Panic Attack | 14 | 1.6 | 1.6 | no signal |
| 153 | Depressed Mood | 20 | 1.6 | 1.6 | no signal |
| 154 | Body Height Decreased | 4 | 1.6 | 1.6 | no signal |
| 155 | Gingival Bleeding | 5 | 1.6 | 1.6 | no signal |
| 156 | Lung Neoplasm Malignant | 15 | 1.5 | 1.5 | no signal |
| 157 | Hypertensive Crisis | 4 | 1.5 | 1.5 | no signal |
| 158 | Mental Disorder | 15 | 1.5 | 1.5 | no signal |
| 159 | Diabetes Mellitus Inadequate Control | 6 | 1.4 | 1.4 | no signal |
| 160 | Product Dose Omission In Error | 9 | 1.4 | 1.4 | no signal |
| 161 | Muscle Rigidity | 4 | 1.4 | 1.4 | no signal |
| 162 | Hallucination, Auditory | 5 | 1.3 | 1.3 | no signal |
| 163 | Affect Lability | 3 | 1.3 | 1.3 | no signal |
| 164 | Inflammatory Bowel Disease | 3 | 1.3 | 1.3 | no signal |
| 165 | Psychomotor Hyperactivity | 5 | 1.3 | 1.3 | no signal |
| 166 | Eczema | 15 | 1.3 | 1.3 | no signal |
| 167 | Uveitis | 4 | 1.3 | 1.3 | no signal |
| 168 | Blindness | 12 | 1.3 | 1.3 | no signal |
| 169 | Blindness Unilateral | 4 | 1.2 | 1.2 | no signal |
| 170 | Drug Withdrawal Syndrome | 25 | 1.2 | 1.2 | no signal |
| 171 | Breast Pain | 3 | 1.2 | 1.2 | no signal |
| 172 | Ischaemic Stroke | 5 | 1.2 | 1.2 | no signal |
| 173 | Synovitis | 5 | 1.2 | 1.2 | no signal |
| 174 | Colon Cancer | 4 | 1.1 | 1.1 | no signal |
| 175 | Breast Cancer Female | 7 | 1.1 | 1.1 | no signal |
| 176 | Menorrhagia | 5 | 1.1 | 1.1 | no signal |
| 177 | Hepatic Cytolysis | 3 | 1.0 | 1.0 | no signal |
| 178 | Drug Effective For Unapproved Indication | 7 | 1.0 | 1.0 | no signal |
| 179 | Product Dispensing Error | 5 | 1.0 | 1.0 | no signal |
| 180 | Osteonecrosis | 7 | 0.9 | 0.9 | no signal |
| 181 | Acne | 16 | 0.9 | 0.9 | no signal |
| 182 | Cytokine Release Syndrome | 4 | 0.9 | 0.9 | no signal |
| 183 | Product Physical Issue | 4 | 0.9 | 0.9 | no signal |
| 184 | Bladder Cancer | 11 | 0.8 | 0.8 | no signal |
| 185 | Injection Site Reaction | 10 | 0.6 | 0.6 | no signal |