This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Gilenya (Fingolimod) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (7628)
Death (227)
Life Threatening Events (208)
Disability (159)
Reports by Reaction Type
Fatigue (1333),
Headache (882),
Dizziness (763),
Nausea (745),
Dyspnoea (539),
Multiple Sclerosis Relapse (495),
Asthenia (474),
Vision Blurred (442),
Heart Rate Decreased (410),
Back Pain (389),
Hypoaesthesia (388),
Pain (361)
Below are a few examples of reports where side effects / adverse reactions may be related to Gilenya (Fingolimod). For a complete list or a specific selection of reports, please use the links above.
Possible Gilenya side effects in 30 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: 30 year old female
Reactions: Rectal Discharge
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a physician from Canada on 2012-08-27
Patient: female
Reactions: Asthma, Condition Aggravated, Rash, Headache, Oropharyngeal Pain, Stress, Tremor, Anxiety, Fatigue, Road Traffic Accident, Neck Pain, Insomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Heart Rate Increased, Blood Pressure Diastolic Increased, Multiple Sclerosis Relapse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Breast Mass
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Nausea, Chills, Headache, Abdominal Pain Upper, Malaise, Neck Pain, Palpitations, Decreased Appetite, Self-Injurious Ideation
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Divalproex Sodium; Cyclobenzaprine; Pantoprazole Sodium; Loratadine; Bumetanide; Oxycodone HCL; Vitamin D; Mirtazapine; Hydroxyzine; Alprazolam; Fentanyl; Dexamethasone
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 74.4 kg (163.6 pounds)
Reactions: Pain in Extremity, Visual Acuity Reduced, Headache, Macular Oedema, Papilloedema, Hyperaesthesia, Heart Rate Decreased, Vision Blurred, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Fampridine; Claritin; Triamcinolone; Serevent; Flomax; Neurontin; Atrovent; Nasonex; Albuterol; Baclofen
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 90.7 kg (199.5 pounds)
Reactions: Fatigue, Vision Blurred, Eye Movement Disorder, Optic Neuritis, Blindness, Eye Pain
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: male
Reactions: Head Discomfort, Pruritus, Flatulence, Vertigo, Headache, Dysentery, Abdominal Pain Upper
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Dorflex
Possible Gilenya side effects in female
Reported by a physician from Germany on 2012-08-27
Patient: female, weighing 68.0 kg (149.6 pounds)
Reactions: Electrocardiogram ST Segment Depression, Heart Rate Decreased, Electrocardiogram T Wave Amplitude Decreased, Coronary Artery Disease, Haemoglobin Increased
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Beta Blocking Agents; Fampyra; Antidepressants
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Electrocardiogram Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female
Reactions: Electrocardiogram QT Prolonged, Musculoskeletal Stiffness, Oropharyngeal Pain, Mobility Decreased
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Estriol
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-27
Patient: female
Reactions: Dyspnoea, Atrial Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: LIP Swelling, Pruritus, Dizziness, Erythema, Sluggishness, Micturition Urgency, Sinus Bradycardia
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 99.8 kg (219.5 pounds)
Reactions: Confusional State, Fatigue, Heart Rate Decreased, Chest Pain
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Provigil; Ritalin; Tricor; Trilipix; Tegretol; Pravastatin
Possible Gilenya side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Arrhythmia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a physician from Canada on 2012-08-27
Patient: female
Reactions: Headache, Hypertensive Crisis
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Oedema Peripheral, Neuritis, Neuralgia
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: White Blood Cell Count Decreased, Back Pain, Muscular Weakness, Multiple Sclerosis Relapse, Neuralgia, Blister, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Electrocardiogram Abnormal
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2012-07-12
Possible Gilenya side effects in male
Reported by a pharmacist from United States on 2012-08-27
Patient: male, weighing 60.8 kg (133.7 pounds)
Reactions: Heart Rate Decreased, Alanine Aminotransferase Increased, Alpha 1 Foetoprotein Increased, Pancreatic Enzymes Increased, Lipase Increased, Hepatic Enzyme Increased
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Back Pain, Skin Injury, Folliculitis, Rhinorrhoea, Gingival Swelling, Headache, Eye Infection, Ingrown Hair, Eye Pain, Gingival Pain, Gingival Erythema, Sneezing, Gingival Infection, Sinusitis, Cough, Infection
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Ibuprofen; Lucenta
Possible Gilenya side effects in female
Reported by a physician from Germany on 2012-08-26
Patient: female
Reactions: Groin Abscess, Herpes Simplex, Swelling, Periorbital Infection, Erythema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a physician from Germany on 2012-08-26
Patient: female
Reactions: Herpes Simplex, Conjunctivitis, Diverticulitis, Herpes Simplex Ophthalmic, Multiple Sclerosis Relapse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Citalopram Hydrobromide; Gabapentin; Pramipexole Dihychloride
Possible Gilenya side effects in 45 year old male
Reported by a consumer/non-health professional from Greece on 2012-08-24
Patient: 45 year old male
Reactions: Haemorrhoids, Condition Aggravated, Erection Increased
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Cervix Carcinoma
Drug(s) suspected as cause:
Gilenya
Administration route: Oral
Indication: Multiple Sclerosis
Gilenya
Administration route: Oral
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-24
Patient: female
Reactions: Pain, Oropharyngeal Pain, Headache, Multiple Sclerosis Relapse, Poor Quality Sleep, Palpitations, Chest Pain, Dizziness, Sinusitis, Breast Pain, Inappropriate Schedule of Drug Administration, Migraine, Middle Ear Effusion, Nausea, Pain in Extremity, Musculoskeletal Pain, Hypoaesthesia, Aggression, Secondary Hypertension, Eyelid Irritation, Vertigo
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qod
Administration route: Oral
Start date: 2012-02-06
End date: 2012-07-14
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2012-01-16
Other drugs received by patient: Baclofen
Possible Gilenya side effects in 40 year old female
Reported by a physician from France on 2012-08-24
Patient: 40 year old female
Reactions: Abdominal Pain, RED Blood Cells Urine
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-24
Patient: male
Reactions: Cholelithiasis, Pancreatitis, Hepatic Enzyme Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, unk
Start date: 2012-01-01
Gilenya
Dosage: 0.5 mg, daily
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2011-12-05
End date: 2012-05-01
Possible Gilenya side effects in female
Reported by a physician from France on 2012-08-24
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: Immune Reconstitution Syndrome, Drug Ineffective, Nuclear Magnetic Resonance Imaging Abnormal, Multiple Sclerosis Relapse
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Alfuzosin Hydrochloride
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female
Reactions: Chest Pain, Heart Rate Irregular, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2010-12-09
End date: 2011-06-01
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Start date: 2011-06-20
Other drugs received by patient: Modafinil; Lunesta; Potassium; Oxybutynin; Losartan Potassium; Lansoprazole; Triamterene; Simvastatin; Favella; Metoprolol Tartrate; Ropinirole; Cytomel; Bethanechol; Ascorbic Acid; Vitamin D; Cranberry; Cupropion; Calcium
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