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Avonex Adverse Events Reported to the FDA Over Time

How are Avonex adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Avonex, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Avonex is flagged as the suspect drug causing the adverse event.

Most Common Avonex Adverse Events Reported to the FDA

What are the most common Avonex adverse events reported to the FDA?

Fall
6851 (2.6%)
Multiple Sclerosis Relapse
5541 (2.1%)
Influenza Like Illness
5267 (2%)
Multiple Sclerosis
4457 (1.69%)
Pneumonia
3321 (1.26%)
Fatigue
3080 (1.17%)
Gait Disturbance
2908 (1.1%)
Pain
2877 (1.09%)
Asthenia
2743 (1.04%)
Myocardial Infarction
2479 (.94%)
Headache
2458 (.93%)
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Death
2366 (.9%)
Depression
2345 (.89%)
Urinary Tract Infection
2344 (.89%)
Pyrexia
2327 (.88%)
Condition Aggravated
2216 (.84%)
Hypoaesthesia
1991 (.76%)
Cerebrovascular Accident
1987 (.75%)
Pain In Extremity
1979 (.75%)
Memory Impairment
1900 (.72%)
Convulsion
1884 (.71%)
Hypertension
1854 (.7%)
Balance Disorder
1760 (.67%)
Vomiting
1629 (.62%)
Abasia
1559 (.59%)
Back Pain
1545 (.59%)
Dehydration
1525 (.58%)
Muscle Spasms
1513 (.57%)
Tremor
1509 (.57%)
Injection Site Pain
1464 (.56%)
Dizziness
1388 (.53%)
Muscular Weakness
1346 (.51%)
Nausea
1339 (.51%)
Breast Cancer
1309 (.5%)
Injection Site Haemorrhage
1301 (.49%)
Dyspnoea
1295 (.49%)
Anxiety
1279 (.49%)
Weight Decreased
1269 (.48%)
Mobility Decreased
1239 (.47%)
Arthralgia
1158 (.44%)
Stress
1157 (.44%)
Loss Of Consciousness
1115 (.42%)
Chills
1097 (.42%)
Diarrhoea
1070 (.41%)
Thrombosis
1056 (.4%)
Insomnia
1051 (.4%)
Road Traffic Accident
1051 (.4%)
Oedema Peripheral
1019 (.39%)
Intervertebral Disc Protrusion
1018 (.39%)
Chest Pain
986 (.37%)
Paraesthesia
929 (.35%)
Breast Cancer Female
922 (.35%)
Hip Fracture
889 (.34%)
Contusion
875 (.33%)
Nasopharyngitis
824 (.31%)
Cystitis
819 (.31%)
Cellulitis
785 (.3%)
Amnesia
771 (.29%)
Decubitus Ulcer
758 (.29%)
Ankle Fracture
757 (.29%)
Diabetes Mellitus
750 (.28%)
Malaise
745 (.28%)
Infection
717 (.27%)
Feeling Abnormal
715 (.27%)
Arthritis
712 (.27%)
Hypotension
711 (.27%)
Cognitive Disorder
703 (.27%)
Injection Site Haematoma
698 (.26%)
Post Procedural Complication
694 (.26%)
Lower Limb Fracture
693 (.26%)
Sepsis
688 (.26%)
Nephrolithiasis
681 (.26%)
Cholelithiasis
671 (.25%)
Coronary Artery Occlusion
670 (.25%)
Hysterectomy
669 (.25%)
Vision Blurred
667 (.25%)
Knee Arthroplasty
666 (.25%)
Migraine
665 (.25%)
Confusional State
650 (.25%)
Anaemia
629 (.24%)
Optic Neuritis
621 (.24%)
Cardiac Failure Congestive
618 (.23%)
Influenza
617 (.23%)
Staphylococcal Infection
616 (.23%)
Urinary Incontinence
607 (.23%)
Visual Impairment
602 (.23%)
Musculoskeletal Stiffness
599 (.23%)
Weight Increased
599 (.23%)
Blood Pressure Increased
598 (.23%)
Drug Ineffective
593 (.22%)
Blood Potassium Decreased
559 (.21%)
Myalgia
556 (.21%)
Speech Disorder
555 (.21%)
Cardiac Disorder
552 (.21%)
Coordination Abnormal
550 (.21%)
Loss Of Control Of Legs
547 (.21%)
Renal Failure
540 (.2%)
Osteoarthritis
528 (.2%)
Asthma
526 (.2%)
Haemorrhage
508 (.19%)
Head Injury
494 (.19%)

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This graph shows the top adverse events submitted to the FDA for Avonex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Avonex is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Avonex

What are the most common Avonex adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Avonex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Avonex is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Avonex According to Those Reporting Adverse Events

Why are people taking Avonex, according to those reporting adverse events to the FDA?

Multiple Sclerosis
83808
Relapsing-remitting Multiple Sclero...
1031
Drug Use For Unknown Indication
580
Product Used For Unknown Indication
376
Drug Exposure During Pregnancy
215
Secondary Progressive Multiple Scle...
34
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Maternal Exposure Timing Unspecifie...
31
Multiple Sclerosis Relapse
22
Maternal Exposure During Pregnancy
17
Progressive Multiple Sclerosis
16
Accidental Exposure
6
Neuromyelitis Optica
5
Exposure Via Father
5
Chronic Inflammatory Demyelinating ...
5
Progressive Relapsing Multiple Scle...
4
Ill-defined Disorder
4
Multiple Myeloma
3
Crohns Disease
3
Disease Progression
3
Foetal Exposure During Pregnancy
3
Maternal Condition Affecting Foetus
3
Hepatitis C
2
Myelopathy
2
Primary Progressive Multiple Sclero...
2
Optic Neuritis
2
General Symptom
2
Demyelination
2
Nervous System Disorder
2
Influenza Like Illness
2
Tropical Spastic Paresis
2
Amyotrophic Lateral Sclerosis
2
Vision Blurred
1
Metabolic Disorder
1
Vitamin C
1
Thrombosis
1
Cerebral Disorder
1
Drug Ineffective
1
Leukoencephalopathy
1
Systemic Lupus Erythematosus
1
Eye Pruritus
1
Gliomatosis Cerebri
1
Sinusitis
1
Rheumatoid Arthritis
1
Osteomyelitis
1
Atrial Fibrillation
1
Abnormal Sensation In Eye
1
Staphylococcal Infection
1
Myosclerosis
1
Malignant Melanoma
1
Blindness
1
Myelitis Transverse
1

Drug Labels

LabelLabelerEffective
AvonexBiogen Idec MA Inc.01-OCT-08
AvonexBiogen Idec MA Inc.29-FEB-12
AvonexBiogen Idec MA Inc.29-FEB-12

Avonex Case Reports

What Avonex safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Avonex. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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