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Rebif (Interferon Beta-1A) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rebif (Interferon Beta-1A) 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 (5972)
Death (182)
Life Threatening Events (109)
Disability (167)

Reports by Reaction Type

Injection Site Erythema (716)Multiple Sclerosis Relapse (680)Injection Site Pain (519)Influenza Like Illness (489)Fall (424)Fatigue (364)Headache (363)Injection Site Haematoma (335)Pain (268)Depression (265)Urinary Tract Infection (265)Hypoaesthesia (221)

Below are a few examples of reports where side effects / adverse reactions may be related to Rebif (Interferon Beta-1A). For a complete list or a specific selection of reports, please use the links above.

Possible Rebif side effects in female

Reported by a physician from Italy on 2012-08-27

Patient: female

Reactions: Proteinuria, Nephroangiosclerosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Levothyroxine Sodium



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Thyroxine Decreased, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Blood Pressure Increased, Urinary Tract Infection, Encephalopathy, Pyrexia, Multiple Sclerosis, Neuralgia, Injection Site Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif
    Indication: Multiple Sclerosis
    Start date: 2006-05-17
    End date: 2006-12-05

Rebif
    Start date: 2007-10-05
    End date: 2012-07-01



Possible Rebif side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: female

Reactions: Anaemia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: female

Reactions: Weight Decreased, Injection Site Haemorrhage, Injection Site Pain, Cerebrovascular Insufficiency

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Cardiac Septal Defect, Muscle Strain, Hypersensitivity, Injection Site Haematoma, Injection Site Induration, Injection Site Pain

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Naproxen



Possible Rebif side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 88.0 kg (193.6 pounds)

Reactions: Injection Site Discolouration, Injection Site Mass, Pain in Extremity, Axillary Mass, Fall, Ligament Sprain

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female

Reactions: Weight Increased, Hypoaesthesia, Headache, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Acetaminophen; Escitalopram; Trilax



Possible Rebif side effects in 72 year old female

Reported by a consumer/non-health professional from Greece on 2012-08-27

Patient: 72 year old female

Reactions: HIP Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Miorel; Modafanil; Cymbalta; Vitamin TAB



Possible Rebif side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female

Reactions: Fall, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Acetaminophen; Ascorbic Acid



Possible Rebif side effects in female

Reported by a consumer/non-health professional from Sweden on 2012-08-27

Patient: female

Reactions: Pain, Abscess

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Cellulitis, Type 2 Diabetes Mellitus, Autoimmune Hepatitis, Staphylococcal Infection, Sepsis, Oedema, Deep Vein Thrombosis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Thyroid Cancer, Optic Neuritis

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in male

Reported by a physician from Brazil on 2012-08-27

Patient: male

Reactions: Labyrinthitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female

Reactions: Angina Pectoris, Stent Placement, Cardiovascular Disorder, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Diltiazem; Isosorbide; Atorvastatin; Losartan Potassium; Vastarel; Aspirin; Clopidegrel



Possible Rebif side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Injection Site Pain, Hernia, Arthritis

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: TAR Shampoo with INL Rinse



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Rectal Haemorrhage, Deep Vein Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Coumadin
    Indication: Thrombosis

Rebif
    Indication: Multiple Sclerosis
    Start date: 2009-11-19
    End date: 2010-01-01

Rebif
    Start date: 2010-01-01



Possible Rebif side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female

Reactions: Intervertebral Disc Protrusion, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Ibuprofen



Possible Rebif side effects in female

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-27

Patient: female

Reactions: Syncope, Chills, Headache, Treatment Noncompliance, Lower Respiratory Tract Infection, Feeling Cold, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprager
    Indication: Depression

Diamicron MR
    Indication: Blood Glucose

Januvia
    Indication: Blood Glucose

Rebif
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-07-18
    End date: 2012-02-06

Rebif
    Start date: 2012-03-01

Other drugs received by patient: Lopraz (Omeprazole); Fluticasone Propionate / Salmeterol; Epilin (Epilim); Florinef; Valproic Acid; Cardiac Medication



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-27

Patient: female

Reactions: Optic Neuritis

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Nausea, Constipation, Fatigue, Injection Site Erythema, Diarrhoea, Fibromyalgia, Depression, Hypertension, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif
    Indication: Multiple Sclerosis
    Start date: 2010-07-27

Rebif



Possible Rebif side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Injection Site Induration, Hypothyroidism, Injection Site Warmth, Multiple Sclerosis Relapse, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Plavix; Odansetron; Promethazine



Possible Rebif side effects in 32 year old female

Reported by a consumer/non-health professional from France on 2012-08-27

Patient: 32 year old female

Reactions: Injection Site Haematoma, Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Cortisone Acetate



Possible Rebif side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27

Patient: female

Reactions: Optic Neuritis

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Crestor; Vitamin D; Irbesartan



Possible Rebif 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 Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Fatigue, Injection Site Erythema, Type 2 Diabetes Mellitus, Injection Site Haematoma, Pain, Cognitive Disorder

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: White Blood Cell Count Decreased, Injection Site Erythema, Systemic Lupus Erythematosus, Injection Site Pain, Lymphoma, Type 1 Diabetes Mellitus, Influenza Like Illness

Drug(s) suspected as cause:
Rebif
    Indication: Multiple Sclerosis
    End date: 2010-02-01

Rebif
    Start date: 2012-03-07

Other drugs received by patient: Steroids



Possible Rebif side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: male

Reactions: Back Pain, Dyspnoea, Haemorrhage, Drug Ineffective, Pain, Headache, Erythema, Suicidal Ideation, Multiple Sclerosis Relapse, Pruritus Generalised, Oral Discomfort, Visual Impairment, Nervousness

Drug(s) suspected as cause:
Rebif

Other drugs received by patient: Motilium; Calcium; Dorflex; Alprazolam



Possible Rebif side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female

Reactions: Glaucoma

Drug(s) suspected as cause:
Rebif



Possible Rebif side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Crohn's Disease, Liver Disorder

Drug(s) suspected as cause:
Rebif

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