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Drug

Fingolimod Hydrochloride

185 flagged reaction(s) · 6,286 total co-reports · max PRR 148.7
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