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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