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AMPYRA

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Ampyra Adverse Events Reported to the FDA Over Time

How are Ampyra adverse event reports trending over time?

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

Most Common Ampyra Adverse Events Reported to the FDA

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

Convulsion
375 (4.54%)
Fall
231 (2.8%)
Dizziness
209 (2.53%)
Multiple Sclerosis Relapse
191 (2.31%)
Gait Disturbance
188 (2.28%)
Urinary Tract Infection
184 (2.23%)
Inappropriate Schedule Of Drug Admi...
170 (2.06%)
Abasia
158 (1.91%)
Balance Disorder
143 (1.73%)
Nausea
136 (1.65%)
Asthenia
130 (1.58%)
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Condition Aggravated
122 (1.48%)
Insomnia
122 (1.48%)
Fatigue
113 (1.37%)
Headache
106 (1.28%)
Loss Of Consciousness
100 (1.21%)
Tremor
99 (1.2%)
Confusional State
95 (1.15%)
Muscular Weakness
93 (1.13%)
Drug Ineffective
90 (1.09%)
Feeling Abnormal
88 (1.07%)
Muscle Spasms
67 (.81%)
Paraesthesia
66 (.8%)
Hypoaesthesia
64 (.78%)
Back Pain
60 (.73%)
Activities Of Daily Living Impaired
58 (.7%)
Grand Mal Convulsion
57 (.69%)
Pain In Extremity
57 (.69%)
Constipation
55 (.67%)
Depression
55 (.67%)
Dyspnoea
54 (.65%)
Dysstasia
54 (.65%)
Disorientation
49 (.59%)
Malaise
47 (.57%)
Vomiting
47 (.57%)
Memory Impairment
46 (.56%)
Multiple Sclerosis
43 (.52%)
Pain
43 (.52%)
Death
42 (.51%)
Therapeutic Response Unexpected
42 (.51%)
Amnesia
38 (.46%)
Nephrolithiasis
38 (.46%)
Speech Disorder
38 (.46%)
Syncope
38 (.46%)
Urinary Incontinence
34 (.41%)
Musculoskeletal Stiffness
32 (.39%)
Anxiety
31 (.38%)
Cystitis
30 (.36%)
Unresponsive To Stimuli
30 (.36%)
Arthralgia
29 (.35%)
Burning Sensation
29 (.35%)
Contusion
29 (.35%)
Head Injury
29 (.35%)
Oedema Peripheral
29 (.35%)
Pneumonia
29 (.35%)
Drug Effect Decreased
28 (.34%)
Pruritus
28 (.34%)
Vision Blurred
28 (.34%)
Weight Decreased
28 (.34%)
Diarrhoea
27 (.33%)
Mental Status Changes
27 (.33%)
Suicidal Ideation
27 (.33%)
Decreased Appetite
25 (.3%)
Hyperventilation
25 (.3%)
Coordination Abnormal
24 (.29%)
Chest Discomfort
23 (.28%)
Drug Dose Omission
23 (.28%)
Tongue Biting
23 (.28%)
Aphasia
21 (.25%)
Cognitive Disorder
21 (.25%)
Hypertension
21 (.25%)
Movement Disorder
21 (.25%)
Oropharyngeal Pain
21 (.25%)
Visual Impairment
21 (.25%)
Abdominal Discomfort
20 (.24%)
Accidental Overdose
20 (.24%)
Hyperhidrosis
20 (.24%)
Vertigo
20 (.24%)
Chills
19 (.23%)
Dehydration
19 (.23%)
Pyrexia
19 (.23%)
Drug Hypersensitivity
18 (.22%)
Dysphagia
18 (.22%)
Eye Movement Disorder
18 (.22%)
Mobility Decreased
18 (.22%)
No Therapeutic Response
18 (.22%)
Chest Pain
17 (.21%)
Erythema
17 (.21%)
Pulmonary Embolism
17 (.21%)
Sensation Of Heaviness
17 (.21%)
Thrombosis
17 (.21%)
Agitation
16 (.19%)
Aspartate Aminotransferase Increase...
16 (.19%)
Bedridden
16 (.19%)
Foot Fracture
16 (.19%)
Influenza Like Illness
16 (.19%)
Kidney Infection
16 (.19%)
Myalgia
16 (.19%)
Palpitations
16 (.19%)
Urticaria
16 (.19%)
Alanine Aminotransferase Increased
15 (.18%)

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This graph shows the top adverse events submitted to the FDA for Ampyra, 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 Ampyra 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 Ampyra

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

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This graph shows the top categories of adverse events submitted to the FDA for Ampyra, 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 Ampyra 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 Ampyra According to Those Reporting Adverse Events

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

Gait Disturbance
1101
Product Used For Unknown Indication
638
Multiple Sclerosis
631
Balance Disorder
56
Muscular Weakness
22
Drug Use For Unknown Indication
21
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Relapsing-remitting Multiple Sclero...
14
Mobility Decreased
14
Fatigue
12
Asthenia
9
Muscle Spasticity
7
Dysstasia
6
Prophylaxis
6
Secondary Progressive Multiple Scle...
6
Abasia
5
Peroneal Nerve Palsy
5
Primary Progressive Multiple Sclero...
4
Fall
4
Pain In Extremity
3
Movement Disorder
3
Adrenoleukodystrophy
3
Immobile
3
General Symptom
3
Headache
2
Dysphonia
2
Dysphagia
2
Memory Impairment
2
Coordination Abnormal
2
Quality Of Life Decreased
2
Wheelchair User
2
Energy Increased
2
Urinary Tract Infection
1
Fibromyalgia
1
Neuromyelitis Optica
1
Progressive Multiple Sclerosis
1
Progressive Relapsing Multiple Scle...
1
Spinal Cord Injury
1
Paraesthesia
1
Paraparesis
1
Urinary Retention
1
Tremor
1
Neuropathy Peripheral
1
Gout
1
Motor Dysfunction
1
Musculoskeletal Stiffness
1
Muscle Spasms
1
Ataxia
1
Myelitis Transverse
1
Cognitive Disorder
1
Hypoaesthesia
1
Gait Spastic
1

Drug Labels

LabelLabelerEffective
AmpyraElan Pharma International LTD01-JAN-10
AmpyraAcorda Therapeutics, Inc.29-JAN-13

Ampyra Case Reports

What Ampyra 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 Ampyra. 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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