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Index of reports
> Life Threatening Events (23)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Betaseron (Interferon Beta-1B) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Betaseron side effects in 48 year old female
Reported by a physician from United Kingdom on 2012-07-23
Patient: 48 year old female
Reactions: Breast Cancer
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Depression, Feeling Abnormal, Depressed Mood
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Dosage: 0.25 mg qod sq
Indication: Multiple Sclerosis
Start date: 2009-11-01
End date: 2010-11-01
Betaseron
Dosage: 0.25 mg qod sq
Indication: Multiple Sclerosis
Start date: 2012-01-01
End date: 2012-04-01
Possible Betaseron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: male, weighing 122.7 kg (269.9 pounds)
Reactions: Depression
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in female
Reported by a consumer/non-health professional from Germany on 2012-07-12
Patient: female, weighing 170.0 kg (374.0 pounds)
Reactions: Weight Decreased, Gastritis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in female
Reported by a lawyer from United States on 2012-07-12
Patient: female
Reactions: Quality of Life Decreased, Pain, General Physical Health Deterioration, Deformity, Emotional Distress, Anhedonia, Bacillus Infection, Injury
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 57 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 57 year old female, weighing 65.8 kg (144.7 pounds)
Reactions: Intracranial Aneurysm
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Levetiracetam; Vitamin D; Prozac; Magnesium Oxide; Aspirin; Multi-Vitamin; Zocor
Possible Betaseron side effects in 56 year old female
Reported by a physician from United States on 2012-06-26
Patient: 56 year old female
Reactions: Cardio-Respiratory Arrest, Sepsis, Pyrexia, Injection Site Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female
Reactions: Suicide Attempt
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-09
Patient: male
Reactions: Injection Site Cellulitis, Injection Site Erythema, Injection Site Pain, Injection Site Warmth, Injection Site Swelling, Injury, Scar
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Betaseron
Dosage: 8 miu, qod
Indication: Multiple Sclerosis
Start date: 2007-02-01
Betaseron
Alcohol
Possible Betaseron side effects in 41 year old male
Reported by a physician from Japan on 2012-04-09
Patient: 41 year old male, weighing 51.0 kg (112.2 pounds)
Reactions: Eating Disorder Symptom, Microangiopathic Haemolytic Anaemia, Eczema, Thrombotic Microangiopathy, Multiple Sclerosis Relapse, Ascites, Malignant Hypertension, Malaise, Face Oedema, Posterior Reversible Encephalopathy Syndrome, Pleural Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 44 year old female
Reported by a consumer/non-health professional from Colombia on 2012-04-02
Patient: 44 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Pain, Administration Site Reaction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Azatriopina
Possible Betaseron side effects in 23 year old male
Reported by a physician from Poland on 2012-03-30
Patient: 23 year old male, weighing 75.0 kg (165.0 pounds)
Reactions: Thrombocytopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 44 year old female
Reported by a consumer/non-health professional from Colombia on 2012-03-27
Patient: 44 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Pain, Injection Site Reaction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Azatriopina
Possible Betaseron side effects in 66 year old female
Reported by a consumer/non-health professional from Switzerland on 2012-03-20
Patient: 66 year old female, weighing 62.0 kg (136.4 pounds)
Reactions: Breast Cancer
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Metoprolol Tartrate and Hydrochlorothiazide; Irbesartan; Aspirin; Levothyroxine Sodium
Possible Betaseron side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: 60 year old female, weighing 57.6 kg (126.7 pounds)
Reactions: Palpitations, Ventricular Tachycardia, Extrasystoles, Depression
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Betaseron
Possible Betaseron side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-09
Patient: female
Reactions: Injection Site Inflammation, Chills, Pain, Pyrexia, Hyperhidrosis, Malaise, Oedema Peripheral, Bacterial Infection, Oedema, Injury, White Blood Cell Count Increased, Blood Pressure Increased, Nausea, Injection Site Pain, Cognitive Disorder, Deformity, Anxiety, Gait Disturbance, Abscess, Necrotising Fasciitis, Asthenia, Disability
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in female
Reported by a consumer/non-health professional from Switzerland on 2012-03-09
Patient: female, weighing 62.0 kg (136.4 pounds)
Reactions: Breast Cancer
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Irbesartan; Metoprolol Tartrate and Hydrochlorothiazide; Aspirin; Levothyroxine Sodium
Possible Betaseron side effects in 27 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-22
Patient: 27 year old female
Reactions: Paranoia, Suicide Attempt, Depression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 28 year old female
Reported by a lawyer from United States on 2012-02-15
Patient: 28 year old female
Reactions: Injection Site Haematoma, Quality of Life Decreased, Pain, Pyrexia, Injection Site Swelling, Injection Site Erythema, Anhedonia, Fatigue, Injury, Injection Site Infection, Injection Site Mass, Injection Site Pain, General Physical Health Deterioration, Deformity, Emotional Distress, Anxiety, Insomnia, Gait Disturbance
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betaseron
Dosage: unk
Start date: 2009-02-20
End date: 2010-03-01
Betaseron
Dosage: betaject
Start date: 2010-09-18
Alcowipes
Betaseron
Dosage: 8 miu, every 2d
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2005-11-04
Other drugs received by patient: Restoril; Vicodin; Naproxen (Aleve)
Possible Betaseron side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-01
Patient: male
Reactions: Product Quality Issue, Injection Site Pain, Injection Site Swelling, Product Contamination, Injection Site Erythema, Dysstasia, Oedema Peripheral, Bacterial Infection, Injection Site Warmth, Injury, Injection Site Infection, Scar
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Betaseron
Dosage: 8 miu, qod
Indication: Multiple Sclerosis
Start date: 2007-02-01
Alcowipes
Possible Betaseron side effects in 27 year old female
Reported by a consumer/non-health professional from United States on 2012-01-24
Patient: 27 year old female
Reactions: Paranoia, Suicide Attempt, Depression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron 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
Possible Betaseron side effects in 25 year old female
Reported by a consumer/non-health professional from Brazil on 2011-10-10
Patient: 25 year old female
Reactions: Thrombosis, Weight Decreased, Abdominal Pain, Wound, Platelet Count Increased, Hyperhidrosis, Hospitalisation, Diarrhoea Haemorrhagic, Emotional Disorder, Multiple Sclerosis, Aphagia, Anaemia, Hypotension, Faecal Incontinence, Tremor, Irritability, Dysphonia, Insomnia, Neutropenia, Renal Pain, Bladder Pain, Myalgia, Speech Disorder, Anorectal Disorder, Depression, Coordination Abnormal, Decreased Appetite, Tooth Fracture, Urinary Tract Infection, Muscular Weakness, Amnesia, Cerebrovascular Accident, Urethral Haemorrhage, Anxiety, Syncope, Gingival Recession, Arthralgia, Respiratory Failure, Diarrhoea, Dysuria, Thrombocytosis, Gait Disturbance, Memory Impairment, Asthenia, Sensitivity of Teeth, Leukopenia
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Betaseron
Dosage: 9.600 miu, qod
Start date: 2010-07-01
End date: 2010-08-01
Betaseron
Dosage: unk
Start date: 2006-01-01
End date: 2006-01-01
Betaseron
Dosage: unk
End date: 2011-06-28
Betaseron
Dosage: betaject
Indication: Secondary Progressive Multiple Sclerosis
Start date: 2001-01-01
Betaseron
Dosage: betaject
Start date: 2010-07-01
End date: 2010-10-15
Other drugs received by patient: Lisador; Lisador; Ranitidine; Voltaren; Morphine; Dulcolax; Dulcolax; Lisador; Nioram
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