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Extavia (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 Extavia (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 (633)
Death (14)
Life Threatening Events (10)
Disability (13)

Reports by Reaction Type

Multiple Sclerosis Relapse (188)Injection Site Erythema (124)Fatigue (114)Hypoaesthesia (111)Pain (107)Headache (95)Injection Site Pain (87)Chills (73)Depression (73)Gait Disturbance (72)Influenza Like Illness (69)Injection Site Haematoma (68)

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

Possible Extavia side effects in 41 year old female

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

Patient: 41 year old female

Reactions: Rheumatoid Arthritis, Wrong Technique in Drug Usage Process, Joint Swelling, Injection Site Irritation

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Pruritus, Alanine Aminotransferase Increased, Injection Site Pain, Injection Site Swelling, Optic Neuritis, Skin Reaction, Injection Site Erythema, Injection Site Reaction, Injection Site Warmth

Drug(s) suspected as cause:
Extavia
    Dosage: 0.3 mg, qod
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-04-01

Extavia
    Dosage: 0.25 mg, qod
    Indication: Multiple Sclerosis



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Germany on 2012-08-21

Patient: female

Reactions: Agitation, Central Nervous System Lesion, Brain Oedema, Hypoaesthesia, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Extavia

Other drugs received by patient: Ibuprofen



Possible Extavia side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Thrombosis, Injection Site Haematoma, Chills, Pain, Headache, Abdominal Discomfort, Injection Site Erythema, Malaise, Oedema Peripheral, Dizziness, Migraine, Dyspnoea, Incorrect Dose Administered, Paraesthesia, Tremor, Limb Discomfort, Heart Rate Increased, Feeling Abnormal, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Extavia
    Dosage: 0.25 ml, qod
    Indication: Multiple Sclerosis
    Start date: 2012-01-24

Extavia
    Dosage: 0.75 ml, qod

Extavia
    Dosage: 1.0 ml, qod

Other drugs received by patient: Warfarin Sodium



Possible Extavia side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Injection Site Haemorrhage, Erythema, Eye Pain, Speech Disorder, Malaise, Fatigue, Thinking Abnormal, Balance Disorder, Gait Disturbance, Memory Impairment, Feeling Abnormal

Drug(s) suspected as cause:
Extavia

Other drugs received by patient: Aspirin; Ibuprofen



Possible Extavia side effects in female

Reported by a physician from United States on 2012-08-17

Patient: female

Reactions: Optic Neuritis, Feeling Abnormal, Influenza Like Illness

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in 57 year old female

Reported by a consumer/non-health professional from Switzerland on 2012-08-17

Patient: 57 year old female

Reactions: Injection Site Haematoma, Sensation of Heaviness, Injection Site Pain, Muscular Weakness, Injection Site Pruritus, Injection Site Erythema, Skin Discolouration, Balance Disorder, Scar

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a physician from Canada on 2012-08-17

Patient: female, weighing 95.2 kg (209.5 pounds)

Reactions: Contusion, Retinal Detachment, Fall, Foot Fracture, Arthralgia, Memory Impairment, Gait Disturbance, Arthritis, Feeling Abnormal

Drug(s) suspected as cause:
Betaseron
    Dosage: 8 miu, qod
    Indication: Relapsing-Remitting Multiple Sclerosis
    End date: 2012-05-01

Extavia
    Dosage: 8 miu, qod
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-05-14



Possible Extavia side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Sensation of Heaviness, Libido Decreased, Cyst

Drug(s) suspected as cause:
Extavia
    Dosage: 1 ml, qod

Extavia
    Dosage: 0.25 mg, qod
    Indication: Multiple Sclerosis
    Start date: 2012-01-27



Possible Extavia side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient: male

Reactions: Chills, Multiple Sclerosis, Nervousness

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a physician from Canada on 2012-08-14

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Back Pain, Injection Site Haematoma, Sensation of Heaviness, Hypoaesthesia, Multiple Sclerosis Relapse, Renal Impairment, Injection Site Erythema, Fatigue, Dysuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in

Reported by a physician from Germany on 2012-08-13

Patient:

Reactions: Ankylosing Spondylitis

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-13

Patient: female

Reactions: Abnormal Sleep-Related Event, Arthropathy, Pain, Neuralgia, Influenza Like Illness

Drug(s) suspected as cause:
Extavia
    Dosage: 8 miu, qod
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-06-18

Extavia
    Dosage: 0.75 ml, unk
    Start date: 2012-07-02
    End date: 2012-07-16



Possible Extavia side effects in female

Reported by a physician from Germany on 2012-08-13

Patient: female

Reactions: Acute Tonsillitis, Conjunctivitis, Urinary Incontinence, Otitis Media, Urinary Retention, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Extavia

Other drugs received by patient: Antibiotics



Possible Extavia side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-09

Patient: female

Reactions: Aneurysm

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in male

Reported by a physician from United States on 2012-08-09

Patient: male

Reactions: Chest Discomfort, Band Sensation, Hypoaesthesia

Drug(s) suspected as cause:
Extavia

Other drugs received by patient: Neurontin; Neurontin



Possible Extavia side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-09

Patient: female

Reactions: Pruritus Generalised, LIP Swelling, Food Allergy

Drug(s) suspected as cause:
Extavia

Other drugs received by patient: Fampridine



Possible Extavia side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-07

Patient: 29 year old female

Reactions: Visual Acuity Reduced, Vision Blurred, Optic Neuritis, Eye Pain

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Germany on 2012-08-07

Patient: female

Reactions: Optic Neuritis, Eye Pain

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Germany on 2012-07-31

Patient: female

Reactions: Abdominal Pain, Nasopharyngitis, Urticaria, Pyrexia, Headache, Abdominal Discomfort, Hot Flush, Uterine Cyst, Injection Site Erythema, Oral Candidiasis, Food Allergy, Feeling Hot, Mood Swings, White Blood Cell Count Increased, Chest Discomfort, Haematuria, Hypoaesthesia, Stress, Paraesthesia, Sleep Disorder, Paresis, Chills, Pain, Multiple Sclerosis Relapse, Hypokinesia, Oophoritis, Depression, Pharyngitis, Migraine, Vomiting, Dyspnoea, Nausea, Urinary Tract Infection, Cystitis, Diarrhoea, Dysaesthesia, Infection, Influenza, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Extavia
    Dosage: 125 ug, qod
    Start date: 2012-01-09
    End date: 2012-02-07

Extavia
    Dosage: 125 ug, qod
    Start date: 2011-09-09
    End date: 2011-12-27

Extavia
    Dosage: 62.5 ug, qod
    Start date: 2011-06-01
    End date: 2011-08-18

Extavia
    Dosage: 62.5 ug, qod
    Indication: Multiple Sclerosis
    Start date: 2011-05-17
    End date: 2011-05-21

Extavia
    Dosage: 1 ml (250 mcg), qod
    End date: 2012-06-29

Extavia
    Dosage: 125 ug, qod
    Start date: 2011-05-23
    End date: 2011-06-01

Other drugs received by patient: Ibuprofen



Possible Extavia side effects in male

Reported by a physician from United States on 2012-07-30

Patient: male

Reactions: Liver Injury, Pain, Feeling Hot, Alanine Aminotransferase Increased, Chills, Transaminases Increased

Drug(s) suspected as cause:
Extavia

Other drugs received by patient: Copaxone; Ibuprofen



Possible Extavia side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-29

Patient: female

Reactions: Movement Disorder, Weight Decreased, Body FAT Disorder, Wrong Technique in Drug Usage Process, Drug Ineffective, Injection Site Haematoma, Injection Site Haemorrhage, Osteoporosis, Urinary Incontinence, Chills, Pain, Headache, Injection Site Irritation, Pyrexia, Injection Site Swelling, Constipation, Hyperhidrosis, Fall, Poor Quality Sleep, Malaise, Fear of Falling, Photophobia, Cellulitis, Muscular Weakness, Injection Site Pain, Injection Site Scab, Mental Impairment, Skin Infection, Gait Disturbance, Frustration

Drug(s) suspected as cause:
Extavia
    Dosage: 0.3 mg, qod

Extavia
    Dosage: 0.25 mg, qod
    Indication: Multiple Sclerosis
    Start date: 2010-05-21

Extavia
    Dosage: 0.25 mg, qod

Extavia
    Dosage: 0.25 mg, qod
    Start date: 2010-03-01

Other drugs received by patient: Bactare; Tylenol



Possible Extavia side effects in female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-07-25

Patient: female

Reactions: Feeling Hot, Sensory Disturbance, Injection Site Pain, Ophthalmoplegia

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Belgium on 2012-07-25

Patient: female

Reactions: Diabetes Mellitus, Visual Acuity Reduced, Injection Site Pain, Erythema

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Canada on 2012-07-24

Patient: female

Reactions: Abnormal Sleep-Related Event, Arthropathy, Pain, Neuralgia, Influenza Like Illness

Drug(s) suspected as cause:
Extavia
    Dosage: 8 miu, qod
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-06-18

Extavia
    Dosage: 0.75 ml, unk
    Start date: 2012-07-02
    End date: 2012-07-16



Possible Extavia side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-23

Patient: female

Reactions: Abdominal Pain, Ovarian Cyst Ruptured

Drug(s) suspected as cause:
Extavia



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Germany on 2012-07-23

Patient: female

Reactions: Abdominal Pain, Nasopharyngitis, Urticaria, Pyrexia, Headache, Abdominal Discomfort, Injection Site Erythema, Hot Flush, Uterine Cyst, Oral Candidiasis, Food Allergy, Feeling Hot, Mood Swings, White Blood Cell Count Increased, Chest Discomfort, Haematuria, Hypoaesthesia, Stress, Paraesthesia, Sleep Disorder, Paresis, Chills, Pain, Multiple Sclerosis Relapse, Hypokinesia, Oophoritis, Depression, Pharyngitis, Migraine, Dyspnoea, Vomiting, Nausea, Urinary Tract Infection, Cystitis, Diarrhoea, Dysaesthesia, Infection, Influenza, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Extavia
    Dosage: 125 ug, qod
    Start date: 2011-05-23
    End date: 2011-06-01

Extavia
    Dosage: 1 ml (250 mcg), qod
    End date: 2012-06-29

Extavia
    Dosage: 125 ug, qod
    Start date: 2011-09-09
    End date: 2011-12-27

Extavia
    Dosage: 125 ug, qod
    Start date: 2012-01-09
    End date: 2012-02-07

Extavia
    Dosage: 62.5 ug, qod
    Indication: Multiple Sclerosis
    Start date: 2011-05-17
    End date: 2011-05-21

Extavia
    Dosage: 62.5 ug, qod
    Start date: 2011-06-01
    End date: 2011-08-18

Other drugs received by patient: Ibuprofen



Possible Extavia side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-23

Patient: male

Reactions: Drug Interaction, Circulatory Collapse

Drug(s) suspected as cause:
Extavia

Other drugs received by patient possibly interacting with the suspect drug:
Analgesics
    Indication: Pain



Possible Extavia side effects in female

Reported by a consumer/non-health professional from Canada on 2012-07-19

Patient: female

Reactions: Contusion, Retinal Detachment, Fall, Foot Fracture, Arthralgia, Gait Disturbance, Memory Impairment, Arthritis, Eye Disorder

Drug(s) suspected as cause:
Betaseron
    Dosage: 8 miu, qod
    Indication: Relapsing-Remitting Multiple Sclerosis
    End date: 2012-05-01

Extavia
    Dosage: 8 miu, qod
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-05-14



Possible Extavia side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: male

Reactions: Completed Suicide, GUN Shot Wound

Adverse event resulted in: death

Drug(s) suspected as cause:
Extavia

Gilenya
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2011-03-08

Other drugs received by patient: Lexapro

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