This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Betaseron (Interferon Beta-1B) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (1687)
Death (88)
Life Threatening Events (23)
Disability (50)
Reports by Reaction Type
Injection Site Pain (146),
Influenza Like Illness (124),
Injection Site Erythema (115),
Depression (110),
Pyrexia (103),
Pain (98),
Fatigue (96),
Headache (90),
Multiple Sclerosis Relapse (83),
Chills (74),
Injection Site Haematoma (73),
Injection Site Reaction (66)
Below are a few examples of reports where side effects / adverse reactions may be related to Betaseron (Interferon Beta-1B). For a complete list or a specific selection of reports, please use the links above.
Possible Betaseron side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Injection Site Necrosis
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 60 year old male
Reactions: Knee Arthroplasty
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 44 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 44 year old female
Reactions: Muscular Weakness, Asthenia, Mobility Decreased
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 34 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 34 year old male
Reactions: Asthma, Pruritus, Scab, Injection Site Pain, Hypoaesthesia, Fatigue, Insomnia, Depression, Injection Site Rash, Multiple Sclerosis, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Ibuprofen; Amitriptyline Hydrochloride; Albuterol Sulfate; Complex B; Gabapentin; Percocet; Folic Acid; Cyanocobalamin; Ibuprofen; Albuterol; Selenium Sulfide; Albuterol Sulfate; Fluticasone Propionate
Possible Betaseron side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 93.0 kg (204.6 pounds)
Reactions: Injection Site Mass, Skin Discolouration, Skin Burning Sensation, Skin Necrosis, Discomfort, Scar
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 63 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Betaseron
Dosage: unk
Start date: 2009-01-01
End date: 2012-07-20
Betaseron
Dosage: unk
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 1999-09-01
End date: 2008-04-10
Possible Betaseron side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 47 year old female, weighing 49.0 kg (107.8 pounds)
Reactions: Abnormal Dreams, Burning Sensation, Thinking Abnormal, Nausea, Trigeminal Neuralgia, Insomnia, Emotional Disorder, Multiple Sclerosis, Crying
Drug(s) suspected as cause:
Betaseron
Dosage: unk
Indication: Multiple Sclerosis
Start date: 2004-01-01
Betaseron
Indication: Trigeminal Neuralgia
Chantix
Dosage: unk
Administration route: Oral
Indication: Smoking Cessation Therapy
Chantix
Dosage: unk
Administration route: Oral
Chantix
Dosage: unk
Administration route: Oral
Neurontin
Dosage: 600 mg, daily
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2004-01-01
Neurontin
Indication: Trigeminal Neuralgia
Rebif
Dosage: 44 ug, 3x/week
Indication: Multiple Sclerosis
Start date: 2004-01-01
Rebif
Indication: Trigeminal Neuralgia
Other drugs received by patient: Hydrocodone; Estradiol
Possible Betaseron side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 61 year old female, weighing 53.5 kg (117.7 pounds)
Reactions: Dizziness
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Clonazepam; Hydrocodone Bitartrate and Acetaminophen; Valium; Bupropion HCL; Acthar; Acyclovir; Vitamin E; Baclofen; Ampyra; Vitamin B-12; Iron; Multi-Vitamins; Amantadine HCL; Diazepam
Possible Betaseron side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 49 year old female, weighing 64.0 kg (140.8 pounds)
Reactions: Pain in Extremity
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Amitriptyline Hydrochloride; Lovaza; Hydrochlorothiazide; Xanax; Vivelle-DOT; Synthroid; Lisinopril
Possible Betaseron side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 33 year old female, weighing 47.6 kg (104.8 pounds)
Reactions: Injection Site Mass, Injection Site Haematoma, Injection Site Scar, Injection Site Rash, Injection Site Pruritus
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 37 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 37 year old female
Reactions: LIP Swelling, Pruritus Generalised, Pharyngeal Hypoaesthesia, Hypoaesthesia Oral, Pharyngeal Oedema, Scab, Swollen Tongue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 50 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 50 year old female
Reactions: Pruritus Generalised, Skin Disorder
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 62 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 62 year old female
Reactions: Malaise, Mucosal Discolouration, Fatigue, Epstein-Barr Virus Test Positive, Injection Site Rash
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 70 year old female, weighing 59.4 kg (130.7 pounds)
Reactions: Gait Disturbance
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Docusate Sodium; Baclofen; Klor-CON; Ibuprofen; Cranberry; Omeprazole; Amantadine HCL; Vitamin D; Detrol
Possible Betaseron side effects in 22 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 22 year old female
Reactions: Influenza Like Illness
Drug(s) suspected as cause:
Betaseron
Other drugs received by patient: Aleve (Caplet)
Possible Betaseron side effects in 34 year old female
Reported by a physician from United States on 2012-08-24
Patient: 34 year old female
Reactions: Retinal Haemorrhage
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 43 year old male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 43 year old male
Reactions: Injection Site Cellulitis, Injection Site Pain, Injection Site Infection
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 52 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 52 year old female
Reactions: Injection Site Haematoma, Pain, Injection Site Pain, Asthenia
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 33 year old female
Reactions: Flushing, Night Sweats, Chills
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Pain in Extremity, Restlessness, Muscle Spasms, Paraesthesia
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 37 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 37 year old female
Reactions: Pruritus Generalised, Hypoaesthesia Oral, Pruritus, Oropharyngeal Swelling, Scab
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 55 year old female
Reported by a physician from Canada on 2012-08-23
Patient: 55 year old female
Reactions: JC Virus Test Positive, Surgery, Drug Hypersensitivity, Lipoatrophy, Progressive Multifocal Leukoencephalopathy
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 63 year old female, weighing 68.5 kg (150.7 pounds)
Reactions: Migraine, non-Cardiac Chest Pain, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betaseron
Dosage: 0.25 mg, qod
Indication: Multiple Sclerosis
Start date: 2011-01-01
Betaseron
Dosage: unk
Start date: 2001-01-01
Other drugs received by patient: Calcium Carbonate W / Colecalciferol; Diltiazem HCL; Tramadol HCL CF; Aspirin; Omeprazole; Metoclopramide; Lactulose; Allegra; Ranitidine; Folic Acid W / Pyrido. HCL / Tocoph. / VIT B12 NOS; Oxybutynin Chloride; Baclofen; Bupropion Hydrochloride; Gabapentin; Rosuvastatin
Possible Betaseron side effects in 32 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 32 year old female
Reactions: Eyelid Oedema, Dysphagia, Chest Discomfort, Rash Generalised, Pharyngeal Oedema, Urticaria
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 61 year old female
Reactions: Injection Site Haemorrhage, Dysphonia, Paranasal Sinus Hypersecretion, Injection Site Rash
Drug(s) suspected as cause:
Betaseron
Dosage: 0.3 mg, qod
Betaseron
Dosage: 0.3 mg, qod
Indication: Multiple Sclerosis
Start date: 2009-07-01
Possible Betaseron side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 55 year old female
Reactions: Balance Disorder, Vision Blurred, Multiple Sclerosis
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: 58 year old female
Reactions: Pain, Chills, Tremor, Feeling Cold, Influenza Like Illness
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 44 year old male
Reported by a physician from United States on 2012-08-23
Patient: 44 year old male
Reactions: Grand MAL Convulsion
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: 67 year old female
Reactions: Injection Site Rash
Drug(s) suspected as cause:
Betaseron
Possible Betaseron side effects in 54 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 54 year old male
Reactions: Multiple Sclerosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Betaseron
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