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ATC Codes: None found

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4
Infection Infection 2% - 72% x x x x
Headache Headache very common, 25% - 25.2% 23% x x x x
Alanine aminotransferase increased Alanine aminotransferase increased very common x
Hepatic enzyme increased Hepatic enzyme increased very common x x
Aspartate aminotransferase increased Aspartate aminotransferase increased 14% 5% x
Influenza Influenza 12.9% x x x x
Cough Cough very common, 10% 8% x x x x
Back pain Back pain very common, 11.8% - 12% 7% x x x x
Diarrhoea Diarrhoea very common, 11.8% - 12% 7% x x x x
Herpes virus infection Herpes NOS 8.71% x
Herpes virus infection common, 9% 8% x x x x
Bronchitis Bronchitis common, 8% - 9.09% 3.59% - 4% x x x x
Dizziness Dizziness common, 7% - 7.29% 6% x x x x
Sinusitis Sinusitis 6.59% - 7% 5% x x x x
Depression Depression common, 8% 7% x x x x
Dyspnoea Dyspnoea common, 8% 5% x x x x
Hypertension Hypertension common, 6% 4% x x x x
Paraesthesia Paraesthesia 5% - 5.41% 4% x x x
Atrioventricular block Atrioventricular block common x x x x
Tinea versicolour Tinea versicolour common x
Migraine Migraine common, 4.71% - 5% 1% x x x x
Gamma-glutamyltransferase increased Gamma-glutamyltransferase increased 5% 1% x
Weight decreased Weight decreased 4.71% - 5% 3% x x x
Gastroenteritis Gastroenteritis 4.47% - 5% 3% x x x
Lymphopenia Lymphopenia common, 4% 1% x x x x
Vision blurred Vision blurred common, 4% 1% x x x x
Alopecia Alopecia common, 3.53% - 4% 2% x x x x
Leukopenia Leukopenia common, 3% 1% x x x x
Bradycardia Bradycardia common, 3.53% - 4% 1% x x x x
Blood triglycerides increased Blood triglycerides increased common, 3% 1% x x x
Tinea infection Tinea infection 3.76% - 4% 1% x x x
Eczema Eczema common, 3% - 3.29% 2% x x x x
Asthenia Asthenia common, 2.59% - 3% 1% x x x x
Fatigue x
Pruritus Pruritus common, 2.59% - 3% 1% x x x x
Eye pain Eye pain 3% 1% x x x
Macular oedema Macular oedema uncommon x x x x
Depressed mood Depressed mood uncommon x
Neutrophil count decreased Neutrophil count decreased uncommon x
Pneumonia Pneumonia uncommon, 0.471% x x x
Autoimmune disorder Autoimmune disorder x
Mental disorder Mental disorder x x x x
Varicella Varicella x x
Connective tissue disorder Connective tissue disorder x x x
Acute disseminated encephalomyelitis Acute disseminated encephalomyelitis x
Eye disorder Eye disorder x x x x
Fatigue Fatigue x
Gastrointestinal disorder Gastrointestinal disorder x x x x
Cardiac arrest Cardiac arrest x x x
Cardiac disorder Cardiac disorder x x x x
Hypotension Hypotension x
Histiocytosis haematophagic Hemophagocytic lymphohistiocytosis x
Lymphoma Lymphoma x x x x
Non-Hodgkin's lymphoma Lymphoma x x x x
Lymphoproliferative disorder Lymphoproliferative disorder x x x
X-linked lymphoproliferative syndrome Lymphoproliferative disorder x x x
Mediastinal disorder Mediastinal disorder x x x
Nervous system disorder Nervous system disorder x x x x
Palpitations Palpitations x
Cerebrovascular accident Cerebrovascular accident x x x
Angiopathy Angiopathy x x x x
Bradyarrhythmia Bradyarrhythmia x x x x
B-cell lymphoma B-cell lymphoma x x x x
Atrioventricular block first degree Atrioventricular block first degree x x x
Lower respiratory tract infection Lower respiratory tract infection x x x
Atrioventricular block complete Atrioventricular block complete x x x
Liver function test abnormal Liver function test abnormal x
Liver injury Liver injury x
Traumatic liver injury Liver injury x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x x x x
Visual acuity reduced Visual acuity reduced x x x
Atrioventricular block second degree Atrioventricular block second degree x x x
Wenckebach phenomenon x x x
Meningoencephalitis herpetic Herpes simplex encephalitis x x
Herpes simplex encephalitis Herpes simplex encephalitis x x
Death Found dead (cause undetermined) x x x
Mean arterial pressure Mean arterial pressure x x
Pre-existing disease Pre-existing disease x x x
Haemorrhagic stroke Haemorrhagic stroke x
Cerebral haemorrhage Haemorrhagic stroke x
Electrocardiogram PR prolongation Electrocardiogram PR prolongation x x x
Herpes zoster Varicella zoster x x
Infestation Infestation NOS x
Multiple sclerosis relapse Multiple sclerosis relapse x x
Peripheral arterial occlusive disease Peripheral arterial occlusive disease x x x x
Posterior reversible encephalopathy syndrome Posterior reversible encephalopathy syndrome x x x x


Information about indications was extracted from the indications and usage sections of the labels.


Side effects:51
Source:FDA Structured Product Label

fingolimod / Gilenya, Capsule

Side effects:61

fingolimod / GILENYA

Side effects:66

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label