Index of reports
> Disability (159)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Gilenya (Fingolimod) disability. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 159 Next >>
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-23
Patient: female
Reactions: Vision Blurred, Visual Acuity Reduced
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in 20 year old female
Reported by a physician from Germany on 2012-08-17
Patient: 20 year old female
Reactions: CD4 Lymphocytes Decreased, Central Nervous System Lesion, Quadriparesis, Quadriplegia, Convulsion
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Swelling, Gait Disturbance, Stress, Multiple Sclerosis Relapse
Adverse event resulted in: hospitalization, disablity
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: 2011-08-01
End date: 2012-03-26
Possible Gilenya side effects in male
Reported by a physician from United States on 2012-08-10
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Fatigue, Eye Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Zanaflex; Provigil; Neurontin; Rebif
Possible Gilenya side effects in female
Reported by a physician from Luxembourg on 2012-08-09
Patient: female
Reactions: Trigeminal Neuralgia, JAW Disorder, Tooth Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: female, weighing 88.4 kg (194.6 pounds)
Reactions: Vitamin D Deficiency, Lymphocyte Percentage Decreased, Body Temperature Increased, Positive Rombergism, Fall, Diplopia, Hypoacusis, Fatigue, Back Pain, Respiratory Rate Increased, Cataract, Vomiting, Pain in Extremity, Varicose Vein, Scotoma, Hypoaesthesia, Macular Oedema, Amnesia, Paraesthesia, Eye Pain, Heart Rate Decreased, Arthralgia, Visual Impairment, Pollakiuria, JAW Disorder, Vision Blurred, Memory Impairment, Gait Disturbance, DRY Eye, Hypertension
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, daily
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-08-25
Gilenya
Administration route: Oral
Start date: 2012-06-27
Other drugs received by patient: Calcium; Lovaza; Provigil; Baclofen; Estradiol; Coq10; Wellbutrin SR; Nexium; Synthroid; Topamax; Vitamin D; Restasis; Calcium with Vitamin D; Ditropan XL; Vitamin D; Estrogel; Doxycycline HCL
Possible Gilenya side effects in 35 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-06
Patient: 35 year old female
Reactions: Blood Alkaline Phosphatase Increased, Cellulitis, Urinary Tract Infection, Platelet Count Increased, Pulmonary Embolism, Monocyte Count Increased, Activated Partial Thromboplastin Time Prolonged, Gamma-Glutamyltransferase Increased, Deep Vein Thrombosis, Lymphocyte Count Decreased, RED Blood Cell Sedimentation Rate Increased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Start date: 2012-05-22
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-10-13
End date: 2012-05-16
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-03
Patient: female
Reactions: Increased Upper Airway Secretion, Nasopharyngitis, Vomiting, Nausea, RED Blood Cell Count Increased, Blepharospasm, Application Site Swelling, Application Site Pruritus, Myalgia, Fatigue, Upper Respiratory Tract Infection, Staring, Gait Disturbance, Pharyngitis Streptococcal, Lymphocyte Count Decreased
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-11-15
Neurontin
Dosage: 300 mg, tid
Indication: Pain
Start date: 2011-12-01
Nicoderm
Dosage: unk ukn, unk
Other drugs received by patient: Propranolol; Zofran; Ascorbic Acid; Zantac; Vesicare; Ibuprofen; Prozac; Valium; Lomotil; Talwin; Phenergan HCL; Percocet; Prilosec
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-08-01
Patient: female
Reactions: Staphylococcal Infection, Vertigo, Dizziness, Pyrexia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Diazepam; Pramipexole Dihychloride; Trileptal; Citalopram Hydrobromide; Ondansetron; Metronidazole; Baclofen; Solu-Medrol; Mirapex
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: female
Reactions: Staphylococcal Infection, Dizziness, Vertigo, Pyrexia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Diazepam; Mirapex; Pramipexole Dihychloride; Trileptal; Ondansetron; Metronidazole; Solu-Medrol; Baclofen; Citalopram Hydrobromide
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-07-30
Patient: female
Reactions: Electrocardiogram QT Prolonged, Heart Rate Decreased, Electrocardiogram Abnormal
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27
Patient: female
Reactions: Drug Ineffective, Central Nervous System Lesion, Nuclear Magnetic Resonance Imaging Abnormal, Multiple Sclerosis Relapse
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-07-25
Patient: male, weighing 75.0 kg (165.0 pounds)
Reactions: Hepatotoxicity, Liver Function Test Abnormal, Multiple Sclerosis Relapse
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Prednisolone
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-24
Patient: female, weighing 89.8 kg (197.6 pounds)
Reactions: White Blood Cell Count Decreased, Malaise, Fatigue, Hypoaesthesia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Vitamin D; Doxycycline; Sertraline Hydrochloride; Fludrocortisone Acetate; Divalproex Sodium; Oxybutynin; Provigil
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-07-24
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Fatigue, T-Lymphocyte Count Decreased, Somnolence, Lymphocyte Count Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Vitamin D; Drospirenone and Ethinyl Estradiol; Clindamycin; Percocet; Ambien; Clindamycin
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-23
Patient: female
Reactions: Confusional State, Central Nervous System Lesion, Dyskinesia, Disorientation, Hemiparesis, Central Nervous System Inflammation, Muscle Rigidity, Somnolence, Multiple Sclerosis Relapse, Loss of Consciousness, Gait Spastic, Partial Seizures With Secondary Generalisation, RED Blood Cell Count Decreased, Aura, White Blood Cell Count Increased, Muscle Spasms, Neurological Decompensation, Lymphopenia, Convulsion, Grand MAL Convulsion, Mental Disorder, Complex Partial Seizures, Acute Disseminated Encephalomyelitis
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Contraceptives
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20
Patient: female, weighing 77.1 kg (169.6 pounds)
Reactions: Nausea, Headache, Pyrexia, Heart Rate Decreased, Fatigue, Dysstasia, Ageusia, Insomnia, Dizziness, Memory Impairment, Asthenia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Start date: 2011-04-20
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-04-15
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Start date: 2011-04-29
End date: 2011-05-09
Other drugs received by patient: Venlafaxine; Albuterol; Calcium; Flonase; Zyrtec; Diazepam; Vitamin D; Olopatadine
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: male
Reactions: White Blood Cell Count Decreased, Anxiety, Panic Attack, Feeling Jittery, Depressed Mood, Nervousness, Lymphocyte Count Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Levoxyl
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-07-16
Patient: female
Reactions: Fear, Central Nervous System Lesion, Abasia, Pain, Paralysis, Muscular Weakness, Hypoaesthesia, Muscle Spasticity, Muscle Tightness, Multiple Sclerosis Relapse, Paraplegia, Thoracic Spine Flattening
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, daily
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-09-03
End date: 2011-09-11
Gilenya
Start date: 2011-09-12
Other drugs received by patient: Metoprolol Tartrate; Fampridine; Baclofen; Lyrica; Sertraline Hydrochloride; Nitrofurantoin; Neurontin; Topral; Amoxicillin
Possible Gilenya side effects in male
Reported by a physician from Switzerland on 2012-07-10
Patient: male
Reactions: Myelitis, Drug Ineffective, Central Nervous System Lesion, Cognitive Disorder, Progressive Multiple Sclerosis, Eye Movement Disorder, Sensorimotor Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Cymbalta
Possible Gilenya side effects in female
Reported by a physician from Luxembourg on 2012-07-10
Patient: female
Reactions: Trigeminal Neuralgia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a physician from United States on 2012-07-09
Patient: male
Reactions: White Blood Cell Count Decreased, Anxiety, Panic Attack, Feeling Jittery, Depressed Mood, Lymphocyte Count Decreased, Nervousness
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Levoxyl
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: female, weighing 71.0 kg (156.2 pounds)
Reactions: Thyroid Cancer, Ovarian Mass
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Zoloft; Trileptal; Nexium; Neurontin
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29
Patient: female
Reactions: Central Nervous System Lesion, Nuclear Magnetic Resonance Imaging Abnormal, Multiple Sclerosis Relapse
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: female, weighing 65.8 kg (144.7 pounds)
Reactions: Limb Discomfort, Influenza
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Ultram; Thyroid TAB; Ddavp; Trazodone HCL; Cymbalta; Adderall XR 10
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-27
Patient: female
Reactions: Nasopharyngitis, Increased Upper Airway Secretion, RED Blood Cell Count Increased, Application Site Swelling, Application Site Pruritus, Upper Respiratory Tract Infection, Staring, Pharyngitis Streptococcal, Gait Disturbance, Lymphocyte Count Decreased
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-11-14
Neurontin
Dosage: 300 mg, tid
Indication: Pain
Start date: 2011-12-01
Nicoderm
Dosage: unk ukn, unk
Other drugs received by patient: Zofran; Prozac; Talwin; Valium; Propranolol; Zantac; Solu-Medrol; Ibuprofen; Phenergan; Lomotil; Percocet; Ascorbic Acid; Prilosec; Vesicare
Possible Gilenya side effects in female
Reported by a physician from United States on 2012-06-27
Patient: female, weighing 83.9 kg (184.6 pounds)
Reactions: Blood Pressure Increased, Fatigue, Chest Discomfort
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Cymbalta; Seasonale; Zyrtec
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-22
Patient: female
Reactions: Hyperpyrexia, Vision Blurred, Fall, Multiple Sclerosis Relapse
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-21
Patient: female
Reactions: Central Nervous System Lesion
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female
Reactions: Vomiting, Nasopharyngitis, Nausea, RED Blood Cell Count Increased, Application Site Swelling, Application Site Pruritus, Upper Respiratory Tract Infection, Gait Disturbance, Staring, Lymphocyte Count Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-11-14
Neurontin
Dosage: 300 mg, tid
Indication: Pain
Start date: 2011-12-01
Nicoderm
Dosage: unk ukn, unk
Other drugs received by patient: Prozac; Valium; Zofran; Ibuprofen; Solu-Medrol; Lomotil; Ascorbic Acid; Phenergan; Propranolol; Percocet; Zantac; Talwin
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