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Gilenya (Fingolimod) - Disability - Suspected Cause - Side Effect Reports

 
 



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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