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Betaseron (Interferon Beta-1B) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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



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

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