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Index of reports
> Cases with Multiple Sclerosis ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Copaxone (Glatiramer) where reactions include multiple sclerosis. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Copaxone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient: female
Reactions: Multiple Sclerosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-26
Patient: female
Reactions: Multiple Sclerosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in 56 year old male
Reported by a consumer/non-health professional on 2012-06-25
Patient: 56 year old male
Reactions: Fatigue, Hypokinesia, Hypoaesthesia, Multiple Sclerosis, Paraesthesia
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-14
Patient: female
Reactions: Urinary Tract Infection, Abnormal Loss of Weight, Visual Acuity Reduced, Hypoaesthesia, Multiple Sclerosis
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in male
Reported by a pharmacist from United States on 2012-06-12
Patient: male
Reactions: Pneumonia, Condition Aggravated, Pancreatitis, Multiple Sclerosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-07
Patient: female
Reactions: Cardiac Arrest, Multiple Sclerosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Copaxone
Indication: Multiple Sclerosis
Start date: 2008-11-01
Natalizumab
Dosage: 10 milligram;
Indication: Multiple Sclerosis
Start date: 2008-06-06
End date: 2008-09-02
Possible Copaxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: male, weighing 111.6 kg (245.5 pounds)
Reactions: Electrocardiogram ST-T Change, Blood PH Increased, Tachycardia, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, Cardiomegaly, X-RAY Abnormal, Activated Partial Thromboplastin Time Prolonged, Malaise, Balance Disorder, Oedema Peripheral, Acute Respiratory Distress Syndrome, Lymphocyte Count Decreased, Back Pain, Haematuria, Cardiomyopathy, Hepatic Steatosis, Vision Blurred, Angiopathy, Anion GAP Decreased, Body Temperature Increased, Wheezing, Aortic Aneurysm, Cardiac Function Test Abnormal, Fall, Haematocrit Decreased, Vomiting, Dyspnoea, Excoriation, Blood Chloride Decreased, Carbon Dioxide Abnormal, Muscular Weakness, Palatal Disorder, Basophil Count Increased, Arthralgia, Sepsis, Gait Disturbance, Lung Infiltration, Asthenia, Pulmonary Hypertension, Pneumonia Aspiration, Wound, Visual Acuity Reduced, Pulmonary Embolism, Nocturia, Loss of Consciousness, RED Cell Distribution Width Increased, Oral Candidiasis, Tenderness, Multiple Sclerosis, Muscle Spasms, Fluid Retention, Cardiac Failure Congestive, Cough, Dysphagia, Anaemia, Hypoaesthesia, Joint Swelling, Rhonchi, Atelectasis, Confusional State, Increased Upper Airway Secretion, Drug Ineffective, Haemorrhage, Aphasia, Constipation, Blood Calcium Decreased, Fatigue, RED Blood Cell Count Decreased, Dizziness, Acute Respiratory Failure, Transient Ischaemic Attack, Blood Glucose Increased, Oxygen Saturation Decreased, Blood Pressure Increased, Inappropriate Schedule of Drug Administration, Blood Urea Increased, Nausea, Haemoptysis, Musculoskeletal Chest Pain, Cognitive Disorder, Myelocyte Count Increased, Eyes Sunken, Haemoglobin Decreased, Osteoarthritis, Oral Disorder, Ejection Fraction Decreased, Bronchitis, Blood Pressure Decreased, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2011-07-21
End date: 2012-01-04
Copaxone
Dosage: 20 mg/ml, qd
Indication: Multiple Sclerosis
Copaxone
Dosage: 20 mg/ml, qd
Start date: 2012-01-27
Other drugs received by patient: Abilify; Methylprednisolone; Coreg; Super B; Azithromycin; Dilaudid; Multivitamin; Influenza Vaccine; Baclofen; Fluconazole; Zofran; Doss; Heparin; Amfetamine W / Dexamfetamine; Glucosamine W / Chondroitin; Methylphenidate HCL; Zithromax; Vitamin D; Docusate Sodium; Albuterol; Ulobetasol; Propranolol; Potassium Chloride; Furosemide; Bupivacaine HCL; Sucralfate; Silodosin; Clonidine; Cyclobenzaprine; Ativan; Prilosec; Sodium Chloride; Ipratropium Bromide; Osteo BI-Flex; Lisinopril; Warfarin Sodium; Cialis; Testosterone; Xopenex; Prozac; Halobetasol Propionate; Ceftriaxone
Possible Copaxone side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-01
Patient: male, weighing 111.6 kg (245.5 pounds)
Reactions: Electrocardiogram ST-T Change, Blood PH Increased, Tachycardia, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, Cardiomegaly, X-RAY Abnormal, Activated Partial Thromboplastin Time Prolonged, Malaise, Balance Disorder, Oedema Peripheral, Acute Respiratory Distress Syndrome, Lymphocyte Count Decreased, Back Pain, Haematuria, Cardiomyopathy, Hepatic Steatosis, Vision Blurred, Angiopathy, Anion GAP Decreased, Body Temperature Increased, Wheezing, Aortic Aneurysm, Cardiac Function Test Abnormal, Fall, Haematocrit Decreased, Vomiting, Dyspnoea, Blood Chloride Decreased, Excoriation, Muscular Weakness, Carbon Dioxide Abnormal, Palatal Disorder, Basophil Count Increased, Arthralgia, Sepsis, Gait Disturbance, Lung Infiltration, Asthenia, Pulmonary Hypertension, Pneumonia Aspiration, Wound, Visual Acuity Reduced, Pulmonary Embolism, Nocturia, Loss of Consciousness, RED Cell Distribution Width Increased, Oral Candidiasis, Tenderness, Multiple Sclerosis, Cardiac Failure Congestive, Fluid Retention, Muscle Spasms, Cough, Dysphagia, Anaemia, Hypoaesthesia, Joint Swelling, Rhonchi, Confusional State, Atelectasis, Increased Upper Airway Secretion, Drug Ineffective, Haemorrhage, Aphasia, Constipation, Blood Calcium Decreased, Fatigue, RED Blood Cell Count Decreased, Dizziness, Transient Ischaemic Attack, Acute Respiratory Failure, Oxygen Saturation Decreased, Blood Glucose Increased, Blood Pressure Increased, Inappropriate Schedule of Drug Administration, Blood Urea Increased, Nausea, Haemoptysis, Musculoskeletal Chest Pain, Cognitive Disorder, Haemoglobin Decreased, Myelocyte Count Increased, Eyes Sunken, Osteoarthritis, Oral Disorder, Ejection Fraction Decreased, Bronchitis, Blood Pressure Decreased, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Copaxone
Dosage: 20 mg/ml, qd
Start date: 2012-01-27
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-07-21
End date: 2012-01-04
Copaxone
Dosage: 20 mg/ml, qd
Indication: Multiple Sclerosis
Other drugs received by patient: Methylprednisolone; Heparin; Ceftriaxone; Dilaudid; Osteo BI-Flex; Multivitamin; Sucralfate; Silodosin; Testosterone; Sodium Chloride; Doss; Furosemide; Ativan; Ipratropium Bromide; Docusate Sodium; Hydromorphone HCL; Prozac; Albuterol; Cyclobenzaprine; Coreg; Warfarin Sodium; Influenza Vaccine; Clonidine; Azithromycin; Baclofen; Fluconazole; Methylphenidate HCL; Omeprazole; Zofran; Zithromax; Lisinopril; Potassium Chloride; Abilify; Ulobetasol; Propranolol; Xopenex
Possible Copaxone side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: 61 year old female
Reactions: Musculoskeletal Disorder, Multiple Sclerosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-01
Patient: male, weighing 111.6 kg (245.5 pounds)
Reactions: Electrocardiogram ST-T Change, Blood PH Increased, Tachycardia, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, X-RAY Abnormal, Cardiomegaly, Activated Partial Thromboplastin Time Prolonged, Malaise, Balance Disorder, Oedema Peripheral, Acute Respiratory Distress Syndrome, Lymphocyte Count Decreased, Back Pain, Haematuria, Cardiomyopathy, Hepatic Steatosis, Vision Blurred, Angiopathy, Anion GAP Decreased, Body Temperature Increased, Aortic Aneurysm, Wheezing, Cardiac Function Test Abnormal, Fall, Haematocrit Decreased, Dyspnoea, Vomiting, Excoriation, Blood Chloride Decreased, Muscular Weakness, Carbon Dioxide Abnormal, Palatal Disorder, Basophil Count Increased, Arthralgia, Sepsis, Gait Disturbance, Lung Infiltration, Asthenia, Pulmonary Hypertension, Pneumonia Aspiration, Wound, Pulmonary Embolism, Visual Acuity Reduced, Nocturia, Loss of Consciousness, RED Cell Distribution Width Increased, Oral Candidiasis, Tenderness, Multiple Sclerosis, Cardiac Failure Congestive, Fluid Retention, Muscle Spasms, Cough, Dysphagia, Anaemia, Hypoaesthesia, Joint Swelling, Rhonchi, Atelectasis, Confusional State, Increased Upper Airway Secretion, Haemorrhage, Drug Ineffective, Aphasia, Constipation, Blood Calcium Decreased, Fatigue, RED Blood Cell Count Decreased, Dizziness, Transient Ischaemic Attack, Acute Respiratory Failure, Blood Glucose Increased, Oxygen Saturation Decreased, Inappropriate Schedule of Drug Administration, Blood Pressure Increased, Blood Urea Increased, Haemoptysis, Nausea, Musculoskeletal Chest Pain, Cognitive Disorder, Myelocyte Count Increased, Eyes Sunken, Haemoglobin Decreased, Osteoarthritis, Oral Disorder, Ejection Fraction Decreased, Bronchitis, Blood Pressure Decreased, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Copaxone
Dosage: 20 mg/ml, qd
Indication: Multiple Sclerosis
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-07-21
End date: 2012-01-01
Copaxone
Dosage: 20 mg/ml, qd
Start date: 2012-01-27
Other drugs received by patient: Silodosin; Azithromycin; Cyclobenzaprine; Dilaudid; Sodium Chloride; Ipratropium Bromide; Lisinopril; Docusate Sodium; Methylprednisolone; Omeprazole; Xopenex; Abilify; Ulobetasol; Hydromorphone HCL; Zithromax; Coreg; Prozac; Albuterol; Ativan; Osteo BI-Flex; Multivitamin; Influenza Vaccine; Methylphenidate HCL; Propranolol; Testosterone; Heparin; Potassium Chloride; Sucralfate; Zofran; Doss; Ceftriaxone; Clonidine; Baclofen; Fluconazole; Furosemide; Warfarin Sodium
Possible Copaxone side effects in female
Reported by a pharmacist from United States on 2012-04-24
Patient: female
Reactions: Thrombosis, Cellulitis, Multiple Sclerosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-24
Patient: male, weighing 111.6 kg (245.5 pounds)
Reactions: Electrocardiogram ST-T Change, Tachycardia, Chronic Obstructive Pulmonary Disease, Cardiomegaly, X-RAY Abnormal, Malaise, Balance Disorder, Oedema Peripheral, Acute Respiratory Distress Syndrome, Back Pain, Haematuria, Cardiomyopathy, Hepatic Steatosis, Vision Blurred, Angiopathy, Body Temperature Increased, Wheezing, Aortic Aneurysm, Fall, Dyspnoea, Vomiting, Excoriation, Muscular Weakness, Palatal Disorder, Arthralgia, Sepsis, Gait Disturbance, Asthenia, Lung Infiltration, Pneumonia Aspiration, Wound, Visual Acuity Reduced, Pulmonary Embolism, Nocturia, Loss of Consciousness, Oral Candidiasis, Tenderness, Multiple Sclerosis, Muscle Spasms, Cardiac Failure Congestive, Cough, Fluid Retention, Dysphagia, Anaemia, Hypoaesthesia, Joint Swelling, Rhonchi, Confusional State, Atelectasis, Increased Upper Airway Secretion, Drug Ineffective, Haemorrhage, Aphasia, Constipation, Fatigue, Dizziness, Transient Ischaemic Attack, Acute Respiratory Failure, Oxygen Saturation Decreased, Blood Pressure Increased, Haemoptysis, Nausea, Progressive Multiple Sclerosis, Musculoskeletal Chest Pain, Cognitive Disorder, Eyes Sunken, Osteoarthritis, Oral Disorder, Bronchitis, Blood Pressure Decreased, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Copaxone
Dosage: 20 mg/ml, qd
Start date: 2012-01-27
Copaxone
Dosage: 20 mg/ml, qd
Indication: Multiple Sclerosis
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-07-21
End date: 2012-01-01
Other drugs received by patient: Methylprednisolone; Omeprazole; Fluoxetine; Lorazepam; Methylphenidate HCL; Propranolol; Xopenex; Dilaudid; Ceftriaxone; Cyclobenzaprine; Fluconazole; Testosterone; Silodosin; Hydromorphone HCL; Ulobetasol; Zithromax; Clonidine; Albuterol; Baclofen; Zofran; Sodium Chloride; Heparin; Abilify; Azithromycin
Possible Copaxone side effects in 27 year old female
Reported by a consumer/non-health professional from United States on 2012-04-05
Patient: 27 year old female
Reactions: Optic Neuritis, Multiple Sclerosis
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-03-28
Patient: 62 year old female
Reactions: Cerebral Infarction, Blood Pressure Abnormal, Multiple Sclerosis, Cough
Drug(s) suspected as cause:
Copaxone
Start date: 1997-01-01
Zestril
Administration route: Oral
Possible Copaxone side effects in 29 year old female
Reported by a physician from United States on 2012-03-07
Patient: 29 year old female
Reactions: Weight Decreased, Spider Naevus, Hepatic Necrosis, Autoimmune Hepatitis, Faecal Incontinence, Condition Aggravated, Liver Disorder, Rash Pruritic, Burning Sensation, Rash Erythematous, Urinary Retention, Memory Impairment, Multiple Sclerosis
Drug(s) suspected as cause:
Copaxone
Start date: 2008-02-01
End date: 2008-06-11
Fucothin
Start date: 2008-05-01
End date: 2008-06-01
Possible Copaxone side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-04
Patient: female
Reactions: Injection Site Mass, Wrong Technique in Drug Usage Process, Injection Site Pain, Multiple Sclerosis
Drug(s) suspected as cause:
Copaxone
Possible Copaxone side effects in 57 year old male
Reported by a physician from United States on 2011-10-28
Patient: 57 year old male
Reactions: Weight Decreased, Cardiac Discomfort, Visual Acuity Reduced, Headache, Pruritus Generalised, Palpitations, Depression Suicidal, Multiple Sclerosis, Muscle Spasms, Bowel Movement Irregularity, Aphagia, Pain in Extremity, Insomnia, Frustration, Muscle Disorder, Retinal Artery Embolism, Peripheral Coldness, Haemorrhage, Wrist Fracture, Abasia, Myelitis Transverse, Constipation, Speech Disorder, Fatigue, Skin Discolouration, Depression, Ligament Sprain, Decreased Appetite, Dyspnoea, Muscular Weakness, Scotoma, Carotid Endarterectomy, Burning Sensation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Dosage: 8 miu, qod
Indication: Secondary Progressive Multiple Sclerosis
Start date: 2008-01-15
Betaseron
Betaseron
Dosage: 8 miu, qod
Betaseron
Dosage: 8 miu, qod
End date: 2011-06-27
Copaxone
Betaseron
Dosage: 8 miu, qod
Start date: 2011-07-08
End date: 2011-01-01
Other drugs received by patient: Ritalin; Oxycontin; Zomig; Lactulose; Oxycodone HCL; Fentanyl-100
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