Index of reports
> Life Threatening Events (208)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Gilenya (Fingolimod) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 208 Next >>
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 physician from Netherlands on 2012-08-20
Patient: female
Reactions: Breast Cancer
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 United States on 2012-08-17
Patient: female
Reactions: Full Blood Count Abnormal, Coma, Peritonitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: unk ukn, unk
Administration route: Oral
Gilenya
Dosage: unk ukn, unk
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2011-05-01
End date: 2011-12-01
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 female
Reported by a physician from France on 2012-08-13
Patient: female
Reactions: Prolonged Expiration, Respiratory Disorder, Escherichia Urinary Tract Infection, Coma Uraemic, Hyperhidrosis, Pericardial Effusion, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Blood Creatinine Increased, Lymphocyte Count Decreased, Blood Lactate Dehydrogenase Increased, Convulsion, Haemolysis, Escherichia Test Positive, Breath Sounds Abnormal, Aspartate Aminotransferase Increased, Gastrointestinal Disorder, Disturbance in Attention, Confusional State, Hyperthermia, Chest X-RAY Abnormal, Left Ventricular Dysfunction, Fatigue, Hypokinesia, Blood Uric Acid Decreased, Acute Respiratory Failure, Thrombocytopenia, Candidiasis, Blood Glucose Increased, Dyspnoea, Blood Urea Increased, Alanine Aminotransferase Increased, Grand MAL Convulsion, Haemoglobin Decreased, Renal Failure, Cardiac Failure, Ejection Fraction Decreased, Mitral Valve Incompetence, Altered State of Consciousness, Sinus Tachycardia, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Vesicare; Aminopyridine; Levocarnil; Lioresal; Piroxicam; Trospium Chloride; Dantrium
Possible Gilenya side effects in female
Reported by a physician from France on 2012-08-13
Patient: female
Reactions: Prolonged Expiration, Respiratory Disorder, Coma Uraemic, Escherichia Urinary Tract Infection, Hyperhidrosis, Pericardial Effusion, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Blood Creatinine Increased, Lymphocyte Count Decreased, Blood Lactate Dehydrogenase Increased, Haemolysis, Convulsion, Escherichia Test Positive, Breath Sounds Abnormal, Aspartate Aminotransferase Increased, Gastrointestinal Disorder, Disturbance in Attention, Confusional State, Hyperthermia, Chest X-RAY Abnormal, Left Ventricular Dysfunction, Hypokinesia, Fatigue, Blood Uric Acid Decreased, Thrombocytopenia, Acute Respiratory Failure, Blood Glucose Increased, Candidiasis, Dyspnoea, Blood Urea Increased, Alanine Aminotransferase Increased, Grand MAL Convulsion, Haemoglobin Decreased, Renal Failure, Cardiac Failure, Ejection Fraction Decreased, Mitral Valve Incompetence, Sinus Tachycardia, Altered State of Consciousness, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Lioresal; Dantrium; Piroxicam; Vesicare; Aminopyridine; Trospium Chloride; Levocarnil
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-10
Patient: female
Reactions: Overdose, Accidental Exposure
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06
Patient: male
Reactions: Pain, Self-Injurious Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in female
Reported by a physician from France on 2012-08-06
Patient: female
Reactions: Prolonged Expiration, Respiratory Disorder, Coma Uraemic, Escherichia Urinary Tract Infection, Hyperhidrosis, Pericardial Effusion, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Blood Creatinine Increased, Myocarditis, Lymphocyte Count Decreased, Blood Lactate Dehydrogenase Increased, Convulsion, Haemolysis, Escherichia Test Positive, Breath Sounds Abnormal, Gastrointestinal Disorder, Aspartate Aminotransferase Increased, Disturbance in Attention, Confusional State, Hyperthermia, Chest X-RAY Abnormal, Fatigue, Left Ventricular Dysfunction, Hypokinesia, Blood Uric Acid Decreased, Acute Respiratory Failure, Thrombocytopenia, Candidiasis, Blood Glucose Increased, Blood Urea Increased, Dyspnoea, Alanine Aminotransferase Increased, Grand MAL Convulsion, Haemoglobin Decreased, Renal Failure, Cardiac Failure, Ejection Fraction Decreased, Mitral Valve Incompetence, Altered State of Consciousness, Sinus Tachycardia, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Levocarnil; Dantrium; Trospium Chloride; Vesicare; Lioresal; Piroxicam; Aminopyridine
Possible Gilenya side effects in female
Reported by a physician from France on 2012-08-06
Patient: female
Reactions: Prolonged Expiration, Respiratory Disorder, Coma Uraemic, Escherichia Urinary Tract Infection, Hyperhidrosis, Pericardial Effusion, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Blood Creatinine Increased, Myocarditis, Lymphocyte Count Decreased, Blood Lactate Dehydrogenase Increased, Haemolysis, Convulsion, Escherichia Test Positive, Breath Sounds Abnormal, Gastrointestinal Disorder, Aspartate Aminotransferase Increased, Disturbance in Attention, Confusional State, Hyperthermia, Chest X-RAY Abnormal, Fatigue, Hypokinesia, Left Ventricular Dysfunction, Blood Uric Acid Decreased, Acute Respiratory Failure, Thrombocytopenia, Candidiasis, Blood Glucose Increased, Blood Urea Increased, Dyspnoea, Alanine Aminotransferase Increased, Haemoglobin Decreased, Grand MAL Convulsion, Renal Failure, Cardiac Failure, Mitral Valve Incompetence, Ejection Fraction Decreased, Sinus Tachycardia, Altered State of Consciousness, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Lioresal; Trospium Chloride; Levocarnil; Piroxicam; Aminopyridine; Dantrium; Vesicare
Possible Gilenya side effects in female
Reported by a physician from Germany on 2012-08-02
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Myocardial Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Pantoprazole; Ramipril; Metoprolol Succinate; Clopidogrel Bisulfate; Aspirin
Possible Gilenya side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-01
Patient: female, weighing 70.0 kg (154.0 pounds)
Reactions: Aphasia, Central Nervous System Lesion, Quadriplegia, Cognitive Disorder, Hemiparesis, Appendicitis Perforated, Multiple Sclerosis Relapse, Peritonitis, Abdominal Abscess, Pelvic Fluid Collection, Acute Disseminated Encephalomyelitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Indication: Multiple Sclerosis
Start date: 2012-03-09
End date: 2012-05-10
Rebif
Dosage: unk ukn, unk
Start date: 2012-05-10
Possible Gilenya side effects in female
Reported by a physician from Canada on 2012-07-31
Patient: female
Reactions: Accidental Exposure
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a physician from Germany on 2012-07-27
Patient: male, weighing 82.0 kg (180.4 pounds)
Reactions: Actinic Keratosis, Metastases To Liver, Basal Cell Carcinoma, Skin Cancer, Metastases To Kidney, Metastases To Central Nervous System, Metastases To Bone, Lung Squamous Cell Carcinoma Stage Unspecified
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Aspirin; Transipeg; Acidum Folicum; Acetaminophen; Novalgin; Norvasc; Calcimagon; Spasmo-Urgenin
Possible Gilenya side effects in female
Reported by a physician from Switzerland on 2012-07-25
Patient: female
Reactions: LOW Birth Weight Baby, Pulmonary Hypertension, Anaemia Neonatal, Thrombocytopenia Neonatal, Foetal Exposure During Pregnancy, Hypernatraemia, Cerebral Haemorrhage, Neonatal Infection, Foetal Growth Restriction, Patent Ductus Arteriosus, Foetal Placental Thrombosis, Atrial Septal Defect, Neonatal Respiratory Distress Syndrome, Premature Baby, Hypotension, Hyperglycaemia, Rhinorrhoea, Leukopenia Neonatal, Bronchopulmonary Dysplasia, Ventricular Septal Defect, Torticollis, Bradycardia Neonatal, Hyperbilirubinaemia Neonatal, Foetal Haemoglobin Decreased, Neonatal Hyponatraemia, Left Atrial Dilatation, Haemangioma, Infantile Apnoeic Attack
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Possible Gilenya side effects in male
Reported by a physician from Germany on 2012-07-25
Patient: male, weighing 82.0 kg (180.4 pounds)
Reactions: Actinic Keratosis, Metastases To Liver, Basal Cell Carcinoma, Lung Neoplasm Malignant, Skin Cancer, Metastases To Kidney, Metastases To Central Nervous System, Metastases To Bone
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Acetaminophen; Transipeg; Spasmo-Urgenin; Acidum Folicum; Norvasc; Aspirin; Novalgin; Calcimagon
Possible Gilenya side effects in male
Reported by a physician from Germany on 2012-07-24
Patient: male, weighing 82.0 kg (180.4 pounds)
Reactions: Actinic Keratosis, Metastases To Liver, Basal Cell Carcinoma, Skin Cancer, Lung Neoplasm Malignant, Metastases To Kidney, Metastases To Central Nervous System, Metastases To Bone
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Calcimagon; Norvasc; Spasmo-Urgenin; Aspirin; Transipeg; Acetaminophen; Novalgin; Acidum Folicum
Possible Gilenya side effects in female
Reported by a physician from France on 2012-07-24
Patient: female
Reactions: Confusional State, Escherichia Urinary Tract Infection, Coma Uraemic, Left Ventricular Dysfunction, Fatigue, Blood Uric Acid Decreased, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Thrombocytopenia, Myocarditis, Blood Creatinine Increased, Blood Glucose Increased, Candidiasis, Lymphocyte Count Decreased, Blood Urea Increased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Convulsion, Haemolysis, Haemoglobin Decreased, Grand MAL Convulsion, Escherichia Test Positive, Renal Failure, Gastrointestinal Disorder, Aspartate Aminotransferase Increased, Disturbance in Attention, Altered State of Consciousness, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Aminopyridine; Trospium Chloride; Levocarnil; Lioresal; Dantrium; Piroxicam; Vesicare
Possible Gilenya side effects in female
Reported by a physician from France on 2012-07-24
Patient: female
Reactions: Confusional State, Escherichia Urinary Tract Infection, Coma Uraemic, Left Ventricular Dysfunction, Fatigue, Blood Uric Acid Decreased, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Blood Creatinine Increased, Thrombocytopenia, Myocarditis, Blood Glucose Increased, Lymphocyte Count Decreased, Candidiasis, Blood Urea Increased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Haemolysis, Convulsion, Haemoglobin Decreased, Grand MAL Convulsion, Escherichia Test Positive, Renal Failure, Gastrointestinal Disorder, Aspartate Aminotransferase Increased, Disturbance in Attention, Altered State of Consciousness, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Lioresal; Vesicare; Aminopyridine; Piroxicam; Trospium Chloride; Dantrium; Levocarnil
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 physician from Germany on 2012-07-19
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Myocardial Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Ramipril; Aspirin; Pantoprazole; Iscover; Metoprolol Succinate
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: female, weighing 67.3 kg (148.0 pounds)
Reactions: Grimacing, Urinary Tract Infection, Dyskinesia, Unresponsive To Stimuli, Drug Interaction, Tonic Clonic Movements, Muscle Rigidity, Convulsion, Loss of Consciousness, Suicidal Ideation, Grand MAL Convulsion, Musculoskeletal Stiffness, Nervous System Disorder, Depression, Muscle Spasms
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient possibly interacting with the suspect drug: Fampridine
Dosage: 10 mg, bid
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2010-07-21
End date: 2011-05-03
Other drugs received by patient: Lexapro; Vitamin B-12; Aleve; Lunesta; Lexapro; Detrol; Vesicare; Provigil; Donepezil HCL; Aricept; Vitamin D; Calcium W / Vitamin D NOS
Possible Gilenya side effects in male
Reported by a physician from United States on 2012-07-10
Patient: male
Reactions: White Blood Cell Count Decreased, Renal Failure, Cellulitis, Sepsis, Urinary Tract Infection, Pyrexia, Toxic Shock Syndrome, Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Simvastatin; Omeprazole; Copaxone; Lovaza
Possible Gilenya side effects in female
Reported by a physician from Germany on 2012-07-10
Patient: female, weighing 59.0 kg (129.8 pounds)
Reactions: Ileus
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2012-01-20
Methylprednisolone
Other drugs received by patient: TRI-Thiazid
Possible Gilenya side effects in 64 year old female
Reported by a physician from Spain on 2012-07-09
Patient: 64 year old female
Reactions: Abdominal Pain, Coma, Pyrexia, Seroma, Paraplegia, Abdominal Distension, Gallbladder Disorder, Pyuria, White Blood Cell Count Increased, Neutrophil Percentage Increased, Protein Urine Present, Nausea, Motor Dysfunction, Nitrite Urine Present, Appendicitis, Appendix Disorder, Mixed Incontinence, White Blood Cells Urine Positive, Gastroenteritis, RED Blood Cells Urine, Bacteriuria, Infectious Peritonitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Start date: 2012-05-01
End date: 2012-05-25
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Start date: 2011-09-01
End date: 2012-03-30
Other drugs received by patient: Antidepressants; Antiarrhythmics, Class I and III
Possible Gilenya side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-06
Patient: male
Reactions: Performance Status Decreased, Cancer Pain, Metastases To Spine, Small Cell Lung Cancer Metastatic
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-10-01
End date: 2012-06-01
Tysabri
Start date: 2007-02-01
End date: 2011-07-21
Other drugs received by patient: Methylprednisolone; Clomipramine HCL; Fampridine; Prednisolone
Possible Gilenya side effects in female
Reported by a physician from France on 2012-07-05
Patient: female
Reactions: Confusional State, Coma Uraemic, Escherichia Urinary Tract Infection, Fatigue, Left Ventricular Dysfunction, Blood Uric Acid Decreased, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Blood Creatinine Increased, Thrombocytopenia, Myocarditis, Candidiasis, Blood Glucose Increased, Lymphocyte Count Decreased, Blood Urea Increased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Haemolysis, Convulsion, Grand MAL Convulsion, Haemoglobin Decreased, Escherichia Test Positive, Renal Failure, Gastrointestinal Disorder, Aspartate Aminotransferase Increased, Disturbance in Attention, Altered State of Consciousness, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Dantrium; Levocarnil; Piroxicam; Trospium Chloride; Lioresal; Aminopyridine; Vesicare
Possible Gilenya side effects in female
Reported by a physician from France on 2012-07-05
Patient: female
Reactions: Confusional State, Escherichia Urinary Tract Infection, Coma Uraemic, Fatigue, Left Ventricular Dysfunction, Blood Uric Acid Decreased, Pulmonary Oedema, Haemolytic Uraemic Syndrome, Thrombocytopenia, Blood Creatinine Increased, Myocarditis, Lymphocyte Count Decreased, Blood Glucose Increased, Candidiasis, Blood Urea Increased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Haemolysis, Convulsion, Grand MAL Convulsion, Haemoglobin Decreased, Escherichia Test Positive, Renal Failure, Aspartate Aminotransferase Increased, Gastrointestinal Disorder, Disturbance in Attention, Altered State of Consciousness, Anisocytosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Other drugs received by patient: Lioresal; Trospium Chloride; Levocarnil; Vesicare; Piroxicam; Aminopyridine; Dantrium
Possible Gilenya side effects in female
Reported by a physician from Germany on 2012-07-04
Patient: female, weighing 66.0 kg (145.2 pounds)
Reactions: Movement Disorder, Tubulointerstitial Nephritis, Brain Mass, Abasia, Central Nervous System Lesion, Aphasia, Optic Neuritis, Hemiparesis, Multiple Sclerosis Relapse, Oscillopsia, Brain Oedema, Blood Creatinine Increased, Renal Failure Acute, Hypertonia, Back Pain, Scotoma, Hypoaesthesia, Renal Hypertrophy, Paraesthesia, Epstein-Barr Virus Infection, Myoclonus, Hyperaesthesia, Vertigo, Dysaesthesia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2010-09-20
End date: 2010-12-20
Sulfadiazine
Other drugs received by patient: Nebivolol; Levothyroxine Sodium; Diovan; Keppra
Possible Gilenya side effects in female
Reported by a consumer/non-health professional from Japan on 2012-07-03
Patient: female
Reactions: White Blood Cell Count Decreased, Vomiting, Neutrophil Count Increased, Nausea, Chills, Pyrexia, Pallor, Discomfort, Bradycardia, Blood Pressure Decreased, Septic Shock, Altered State of Consciousness, Lymphocyte Count Decreased, Infection
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
End date: 2012-05-01
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2012-02-10
End date: 2012-03-31
Other drugs received by patient: Potassium Chloride; Prednisolone; Corticosteroids; Selbex; Lactec; Immunoadsorption Therapy; Lansoprazole; Vitamin B12; Alendronate Sodium; Betaseron
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