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

 
 



Index of reports > Cases with Asthenia (474)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Gilenya (Fingolimod) where reactions include asthenia. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 474   Next >>

Possible Gilenya side effects in male

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

Patient: male

Reactions: Dyspnoea, Hypotension, Ataxia, Laceration, Muscular Weakness, Fall, Paraesthesia, Loss of Consciousness, Concussion, Dizziness, Gait Disturbance, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya



Possible Gilenya side effects in female

Reported by a physician from Germany on 2012-08-23

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Palpitations, Dizziness, Asthenia, Oral Pustule

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Fampridine



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-21

Patient: female

Reactions: White Blood Cell Count Decreased, Chest Discomfort, Blood Creatine Phosphokinase Increased, Oropharyngeal Pain, Lower Respiratory Tract Infection, Balance Disorder, Musculoskeletal Stiffness, Nodule, Asthenia, Aphonia

Drug(s) suspected as cause:
Gilenya



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-21

Patient: female

Reactions: Condition Aggravated, Oropharyngeal Pain, Vocal Cord Inflammation, Fatigue, Overdose, Arthralgia, Gait Disturbance, Asthenia, Aphonia, Neuralgia, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Escitalopram; Clonazepam; Escitalopram; Tramadol Hydrochloride; Lyrica



Possible Gilenya side effects in 44 year old female

Reported by a physician from Mexico on 2012-08-17

Patient: 44 year old female

Reactions: Heart Rate Decreased, Nausea, Orthostatic Hypotension, Dizziness, Asthenia

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 Germany on 2012-08-16

Patient: male

Reactions: Dyspnoea, Hypotension, Laceration, Muscular Weakness, Fall, Paraesthesia, Loss of Consciousness, Concussion, Dizziness, Gait Disturbance, Asthenia

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 2012-08-16

Patient: female

Reactions: Personality Change, Confusional State, Contusion, Restless Legs Syndrome, Central Nervous System Lesion, Pain, Headache, Fall, Speech Disorder, Diplopia, Balance Disorder, Oedema Peripheral, Dizziness, Clumsiness, Lethargy, Lymphocyte Count Decreased, Back Pain, Pain in Extremity, Laceration, Hypoaesthesia, Amnesia, Visual Impairment, Vision Blurred, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2011-09-20
    End date: 2012-08-07

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral

Other drugs received by patient: Aricept; Loratadine; Risperidone; Gabapentin; Tramadol; Depakote; Amitriptyline HCL; Contraceptives; Amitriptyline HCL



Possible Gilenya side effects in female

Reported by a physician from United States on 2012-08-15

Patient: female

Reactions: Vitamin D Deficiency, Confusional State, Productive Cough, Wound, Mental Status Changes, Pyrexia, Fall, Hypokalaemia, PO2 Decreased, Hot Flush, Malaise, Fatigue, Joint Range of Motion Decreased, Muscle Spasms, Dyspnoea, Pneumonia, Urinary Tract Infection, Ataxia, Rash, Nasal Congestion, Respiratory Distress, Uhthoff's Phenomenon, Dysarthria, Gait Disturbance, Blood Pressure Decreased, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-06-01
    End date: 2012-05-29

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Start date: 2012-06-27

Other drugs received by patient: Albuterol Sulfate and Ipratropium Bromide; Motrin; Calcium W / Vitamin D NOS; Potassium Bicarbonate; Iopamidol; Advil; Oxybutynin Chloride; Trypsin-Balsam-Castor OIL; Enoxaparin; Fampridine; Sertraline Hydrochloride; Calcium Carbonate W / Vitamin D NOS; Nystatin; Rocephin; Potassium Chloride; Excedrin (Migraine)



Possible Gilenya side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: female

Reactions: Electrocardiogram QT Prolonged, Electrocardiogram ST Segment Depression, Ventricular Hypokinesia, Tricuspid Valve Incompetence, Hyperhidrosis, Coronary Artery Occlusion, Pulmonary Congestion, Pleural Effusion, Pulmonary Oedema, Orthopnoea, Myocardial Infarction, Blood Creatinine Increased, Cardiac Failure Congestive, Renal Failure Acute, Ventricular Extrasystoles, Blood Pressure Increased, Chest Discomfort, Dyspnoea, Angina Pectoris, Coronary Artery Stenosis, Diastolic Dysfunction, Electrocardiogram QRS Complex Abnormal, Cardiac Aneurysm, Haemoglobin Decreased, Ejection Fraction Decreased, Left Atrial Dilatation, Aortic Valve Incompetence, Asthenia, Electrocardiogram ST Segment Elevation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Vitamin D; Ferrous Sulfate TAB; Glucophage; Protonix; Excedrin (Migraine); Vitamin D; Aspirin; Potassium Chloride; Trilipix; Propylene Glycol; Caltrate 600 + Vitamin D; Coreg; Cymbalta; Niaspan; Plavix; Synthroid; Cozaar; Nasonex; Ascorbic Acid; Lasix; Atenolol; Pepcid



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Urinary Tract Infection, Central Nervous System Lesion, Muscular Weakness, Tremor, Anxiety, Temperature Intolerance, Asthenia, Depressed Mood

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya



Possible Gilenya side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 54 year old female

Reactions: Drug Dose Omission, Pain in Extremity, Fall, Balance Disorder, Oedema Peripheral, Musculoskeletal Stiffness, Gait Disturbance, Asthenia, Hallucination

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, q 12 hrs, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01

Gilenya
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01
    End date: 2012-07-16

Tysabri
    Dosage: 1 dose
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-01
    End date: 2012-07-01



Possible Gilenya side effects in female

Reported by a physician from Canada on 2012-08-09

Patient: female

Reactions: Urinary Incontinence, Extensor Plantar Response, Abdominal Pain Upper, Fatigue, Cluster Headache, Nystagmus, Dizziness, Coordination Abnormal, Ophthalmoplegia, Dyspnoea, Nausea, Muscular Weakness, Hypoaesthesia, Micturition Urgency, Tremor, Diarrhoea, Bradycardia, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Zopiclone; Estrogel; Vitamin D; Calcium



Possible Gilenya side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient: female

Reactions: Ejection Fraction Decreased, Myocardial Infarction, Asthenia

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 Germany on 2012-08-09

Patient: female

Reactions: Drug Ineffective, Muscular Weakness, Fall, Feeling Cold, Fatigue, Balance Disorder, Asthenia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Amlodipine; Losartan Potassium; Folic Acid



Possible Gilenya side effects in male

Reported by a consumer/non-health professional from Poland on 2012-08-09

Patient: male

Reactions: Contusion, Tinnitus, Nasopharyngitis, Oropharyngeal Pain, Headache, Pyrexia, Neoplasm, Rash Pruritic, Oral Discomfort, Balance Disorder, Nystagmus, Oedema Peripheral, DRY Throat, Feeling Hot, Multiple Sclerosis, Blepharospasm, Malnutrition, Nasal Congestion, Torticollis, Venous Insufficiency, Stress, Tremor, Throat Irritation, Communication Disorder, Insomnia, Pain, Central Nervous System Lesion, Chills, Poor Quality Sleep, Fatigue, Neck Pain, Venous Stenosis, Dizziness, Hypertonic Bladder, White Blood Cell Count Decreased, Vomiting, Dyspnoea, Nausea, Muscular Weakness, Eye Pain, Burning Sensation, Dysgeusia, Syncope, Hyperaesthesia, Visual Impairment, Memory Impairment, Gait Disturbance, Asthenia, Blood Pressure Decreased, Hypertension, Feeling Abnormal, Infection

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Linseed; Antithrombotic Agents; Ascorbic Acid; Aspirin



Possible Gilenya side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 90.7 kg (199.5 pounds)

Reactions: Asthma, Asthenia

Drug(s) suspected as cause:
Gilenya



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-02

Patient: female

Reactions: Condition Aggravated, Oropharyngeal Pain, Vocal Cord Inflammation, Fatigue, Overdose, Arthralgia, Gait Disturbance, Asthenia, Aphonia, Neuralgia, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Rivotril; Escitalopram; Escitalopram; Tramadol Hydrochloride; Lyrica



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Israel on 2012-08-02

Patient: female

Reactions: Viral Infection, Nausea, Urinary Tract Infection, Oropharyngeal Pain, Balance Disorder, Diarrhoea, Dizziness, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Bisoprolol Fumarate



Possible Gilenya side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: female

Reactions: Confusional State, Encephalomalacia, Central Nervous System Lesion, Postictal State, Paranasal Sinus Mucosal Hypertrophy, Electroencephalogram Abnormal, Grand MAL Convulsion, Fatigue, Limb Discomfort, Arthralgia, Neurodegenerative Disorder, Depression, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Multi-Vitamins; Aspirin; Citracal; Colace; Laxatives; Citalopram Hydrobromide; Topamax



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female, weighing 87.5 kg (192.6 pounds)

Reactions: Contusion, Paralysis, Oropharyngeal Pain, Joint Stiffness, CSF Volume Increased, Electroencephalogram Abnormal, Balance Disorder, Oedema Peripheral, Aura, Back Pain, Polydipsia, Blood Thyroid Stimulating Hormone Decreased, Stress, Euphoric Mood, Sleep Disorder, Dysphonia, Vision Blurred, Very LOW Density Lipoprotein Decreased, Mental Status Changes, Muscle Tightness, Somnolence, Fall, Speech Disorder, Poor Quality Sleep, Posterior Reversible Encephalopathy Syndrome, Brain Oedema, Depression, Dyspnoea, Paraesthesia Oral, Dysgeusia, Arthralgia, Visual Impairment, Memory Impairment, Bronchial Hyperreactivity, DRY Eye, Asthenia, Obsessive Thoughts, Head Titubation, Blood Albumin Decreased, Pyrexia, Headache, Brain Injury, Epistaxis, Muscle Spasms, Bowel Movement Irregularity, Intervertebral Disc Protrusion, Pain in Extremity, Hypoaesthesia, Micturition Urgency, Tremor, Convulsion, Paraesthesia, Myoclonus, Disturbance in Attention, Confusional State, Creatinine Renal Clearance Decreased, Haemorrhage, Labile Hypertension, Dyskinesia, Central Nervous System Lesion, Petechiae, Diplopia, Fatigue, Neck Pain, Photophobia, Clumsiness, Dizziness, Coordination Abnormal, Migraine, Nausea, Urinary Tract Infection, Cognitive Disorder, Muscle Twitching, Anxiety, Diarrhoea, Dysuria, Vertigo, Blindness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Klonopin; Synthroid; Prozac; Topamax; Trazodone Hydrochloride; Adderall 5; Amantadine HCL; Thyroid TAB; Gabapentin; Valium; Levothyroxine Sodium; Provigil; Lasix; Keppra; Byetta; Albuterol; Atrovent



Possible Gilenya side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male

Reactions: Central Nervous System Lesion, Muscle Spasticity, Multiple Sclerosis Relapse, Neuropathy Peripheral, Haematocrit Decreased, Arthropathy, RED Blood Cell Count Decreased, Oedema Peripheral, Photophobia, Intervertebral Disc Degeneration, Vertebral Foraminal Stenosis, Mean Cell Haemoglobin Concentration Increased, Cervical Spinal Stenosis, Lymphocyte Count Decreased, Demyelination, Intervertebral Disc Protrusion, Eosinophil Count Decreased, Hiatus Hernia, Cellulitis, Muscular Weakness, Mean Cell Volume Increased, Brachial Plexopathy, Haemoglobin Decreased, Vision Blurred, Hypertension, Asthenia, Deep Vein Thrombosis, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2011-03-09
    End date: 2011-04-20

Gilenya
    Dosage: 0.5 mg, daily
    Administration route: Oral
    End date: 2012-01-01

Other drugs received by patient: Prednisone; Lovenox; Dabigatran; Pepcid; Lisinopril; Coumadin; Baclofen; Norco; Hydrocodone; Solu-Medrol; Amlodipine



Possible Gilenya side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Blood Pressure Increased, Chest Discomfort, Eye Irritation, Pain in Extremity, Sensation of Heaviness, Hypoaesthesia, Muscle Rigidity, Eye Pain, Fatigue, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Flexeril; Xyzal; Bentyl; Celebrex; Protonix; Aspirin; Benadryl CD; Anaprox; Fioricet; Fampridine; Cozaar



Possible Gilenya side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: male

Reactions: Central Nervous System Lesion, Muscle Spasticity, Multiple Sclerosis Relapse, Haematocrit Decreased, Arthropathy, Neuropathy Peripheral, RED Blood Cell Count Decreased, Photophobia, Oedema Peripheral, Intervertebral Disc Degeneration, Vertebral Foraminal Stenosis, Mean Cell Haemoglobin Concentration Increased, Cervical Spinal Stenosis, Lymphocyte Count Decreased, Demyelination, Eosinophil Count Decreased, Intervertebral Disc Protrusion, Hiatus Hernia, Cellulitis, Muscular Weakness, Mean Cell Volume Increased, Haemoglobin Decreased, Brachial Plexopathy, Vision Blurred, Asthenia, Hypertension, Mobility Decreased, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2011-03-09
    End date: 2011-04-20

Gilenya
    Dosage: 0.5 mg, daily
    Administration route: Oral
    End date: 2012-01-01

Other drugs received by patient: Pradaxa; Solu-Medrol; Amlodipine; Hydrocodone; Lisinopril; Coumadin; Baclofen; Pepcid; Prednisone; Norco; Lovenox



Possible Gilenya side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 49 year old female

Reactions: Fatigue, Asthenia

Drug(s) suspected as cause:
Betaseron
    Dosage: 8 miu, qod
    Indication: Multiple Sclerosis

Gilenya
    Dosage: unk
    Start date: 2012-07-16



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Israel on 2012-07-27

Patient: female

Reactions: Viral Infection, Nausea, Balance Disorder, Urinary Tract Infection, Dizziness, Oropharyngeal Pain, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Bisoprolol Fumarate



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-27

Patient: female

Reactions: Condition Aggravated, Oropharyngeal Pain, Vocal Cord Inflammation, Overdose, Fatigue, Arthralgia, Gait Disturbance, Asthenia, Neuralgia, Aphonia, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Escitalopram; Escitalopram; Lyrica; Tramadol Hydrochloride; Clonazepam



Possible Gilenya side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: female, weighing 87.5 kg (192.6 pounds)

Reactions: Contusion, Paralysis, Oropharyngeal Pain, Joint Stiffness, Electroencephalogram Abnormal, Balance Disorder, Oedema Peripheral, Aura, Back Pain, Polydipsia, Blood Thyroid Stimulating Hormone Decreased, Stress, Euphoric Mood, Sleep Disorder, Dysphonia, Vision Blurred, Very LOW Density Lipoprotein Decreased, Mental Status Changes, Fall, Muscle Tightness, Somnolence, Poor Quality Sleep, Speech Disorder, Posterior Reversible Encephalopathy Syndrome, Brain Oedema, Depression, Dyspnoea, Paraesthesia Oral, Dysgeusia, Arthralgia, Visual Impairment, Memory Impairment, Bronchial Hyperreactivity, Asthenia, DRY Eye, Obsessive Thoughts, Head Titubation, Blood Albumin Decreased, Pyrexia, Headache, Epistaxis, Muscle Spasms, Bowel Movement Irregularity, Intervertebral Disc Protrusion, Pain in Extremity, Hypoaesthesia, Micturition Urgency, Paraesthesia, Tremor, Convulsion, Myoclonus, Disturbance in Attention, Confusional State, Creatinine Renal Clearance Decreased, Haemorrhage, Labile Hypertension, Dyskinesia, Central Nervous System Lesion, Petechiae, Diplopia, Fatigue, Neck Pain, Photophobia, Clumsiness, Dizziness, Coordination Abnormal, Migraine, Nausea, Urinary Tract Infection, Cognitive Disorder, Muscle Twitching, Anxiety, Diarrhoea, Dysuria, Vertigo

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Thyroid TAB; Trazodone Hydrochloride; Topamax; Synthroid; Gabapentin; Adderall 5; Valium; Atrovent; Prozac; Provigil; Lasix; Keppra; Byetta; Albuterol; Amantadine HCL; Klonopin; Levothyroxine Sodium



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female, weighing 97.1 kg (213.5 pounds)

Reactions: Jaundice, Abdominal Pain, Blood Bilirubin Increased, Blood Albumin Decreased, Blood Calcium Decreased, Fatigue, Yellow Skin, Hepatotoxicity, Peroneal Nerve Palsy, Blood Alkaline Phosphatase Increased, Urinary Tract Infection, Alanine Aminotransferase Increased, Muscular Weakness, Protein Total Decreased, Aspartate Aminotransferase Increased, Hypotonia, Sensory Disturbance, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Ativan; HEP-Lock; Ascorbic Acid; Sodium Phosphates; Lovenox; Neurontin; Vesicare; Lioresal; Multiple Vitamin; Nefazodone HCL; Fampridine; Dulcolax; Potassium Chloride; Saline; Calcium Carbonate W / Vitamin D NOS; Ambien; Ferrous Sulfate TAB



Possible Gilenya side effects in female

Reported by a consumer/non-health professional from Argentina on 2012-07-25

Patient: female

Reactions: Limb Discomfort, Swelling, Gait Disturbance, Asthenia

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 United States on 2012-07-23

Patient: female, weighing 118.0 kg (259.6 pounds)

Reactions: Fatigue, Dyspnoea, Syncope, Circulatory Collapse, Multiple Sclerosis, Asthenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Gilenya

Other drugs received by patient: Abilify; Gabapentin; Amitriptyline HCL; Clonazepam; Phentermine; Tizanidine Hydrochloride; Risperdal; Trazodone Hydrochloride; Xanax; Lamictal



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