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Gilenya (Fingolimod) - Side Effect Reports to FDA

 
 



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 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 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 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 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 male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Ventricular Extrasystoles, Dyspnoea, Palpitations, Supraventricular Extrasystoles, Tachycardia, Dizziness, Bradycardia, Sinus Arrhythmia

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2012-07-18
    End date: 2012-07-30

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    End date: 2012-08-16

Other drugs received by patient: Vitamin D; Ibuprofen (Advil); Alprazolam



Possible Gilenya side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female, weighing 121.0 kg (266.2 pounds)

Reactions: Skin Lesion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Gilenya



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-24

Patient: female

Reactions: Exophthalmos, Glaucoma, Foreign Body Sensation in Eyes, Visual Impairment, Intraocular Pressure Increased, Eye Swelling, Macular Oedema

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-07-06
    End date: 2011-11-02

Gilenya
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Start date: 2011-11-10

Steroids NOS

Other drugs received by patient: Multi-Vitamins; Vitamin D; Synthroid



Possible Gilenya side effects in female

Reported by a physician from Canada on 2012-08-24

Patient: female

Reactions: Drug Ineffective, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Copaxone
    Indication: Multiple Sclerosis

Gilenya
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-10-14



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

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