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BOTULINUM TOXIN TYPE A

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Botulinum Toxin Type A Adverse Events Reported to the FDA Over Time

How are Botulinum Toxin Type A adverse event reports trending over time?

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

Most Common Botulinum Toxin Type A Adverse Events Reported to the FDA

What are the most common Botulinum Toxin Type A adverse events reported to the FDA?

Muscular Weakness
212 (3.75%)
Dysphagia
205 (3.62%)
Drug Ineffective
184 (3.25%)
Dyspnoea
115 (2.03%)
Asthenia
114 (2.02%)
Eyelid Ptosis
108 (1.91%)
Headache
105 (1.86%)
Fatigue
86 (1.52%)
Therapeutic Response Decreased
79 (1.4%)
Nausea
78 (1.38%)
Neck Pain
74 (1.31%)
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Dizziness
70 (1.24%)
Pyrexia
65 (1.15%)
Botulism
62 (1.1%)
Injection Site Pain
51 (.9%)
Weight Decreased
51 (.9%)
Vision Blurred
50 (.88%)
Pain
48 (.85%)
Speech Disorder
48 (.85%)
Influenza Like Illness
47 (.83%)
Respiratory Failure
46 (.81%)
Convulsion
40 (.71%)
Diarrhoea
39 (.69%)
Dysphonia
39 (.69%)
Swelling Face
38 (.67%)
Vomiting
38 (.67%)
Wrong Technique In Drug Usage Proce...
35 (.62%)
Diplopia
34 (.6%)
Gait Disturbance
34 (.6%)
Malaise
34 (.6%)
Pneumonia
33 (.58%)
Pneumonia Aspiration
33 (.58%)
Fall
32 (.57%)
Muscle Spasms
32 (.57%)
Anxiety
31 (.55%)
Tremor
31 (.55%)
Urinary Tract Infection
30 (.53%)
Back Pain
29 (.51%)
Facial Paresis
28 (.49%)
Migraine
27 (.48%)
Nervous System Disorder
26 (.46%)
Hypoaesthesia
25 (.44%)
Injection Site Reaction
25 (.44%)
Feeling Abnormal
24 (.42%)
Pain In Extremity
24 (.42%)
Rash
24 (.42%)
Choking
23 (.41%)
Lethargy
23 (.41%)
Musculoskeletal Pain
23 (.41%)
Chest Pain
22 (.39%)
Dry Mouth
22 (.39%)
Chest Discomfort
21 (.37%)
Myalgia
21 (.37%)
Constipation
20 (.35%)
Loss Of Consciousness
20 (.35%)
Paraesthesia
20 (.35%)
Syncope
20 (.35%)
Hypersensitivity
19 (.34%)
Hypertension
19 (.34%)
Movement Disorder
19 (.34%)
Rash Generalised
19 (.34%)
Urinary Retention
19 (.34%)
Urosepsis
19 (.34%)
Urticaria
19 (.34%)
Death
18 (.32%)
Eye Pain
18 (.32%)
Lymphoedema
18 (.32%)
Photophobia
18 (.32%)
Confusional State
17 (.3%)
Depression
17 (.3%)
Dysarthria
17 (.3%)
Hypotonia
16 (.28%)
Injection Site Swelling
16 (.28%)
Abdominal Pain Upper
15 (.27%)
Hyperhidrosis
15 (.27%)
Oedema Peripheral
15 (.27%)
Acute Respiratory Failure
14 (.25%)
Aspiration
14 (.25%)
Burning Sensation
14 (.25%)
Cerebrovascular Accident
14 (.25%)
Condition Aggravated
14 (.25%)
Erythema
14 (.25%)
Joint Range Of Motion Decreased
14 (.25%)
Respiratory Tract Infection
14 (.25%)
Skin Tightness
14 (.25%)
Tachycardia
14 (.25%)
Visual Acuity Reduced
14 (.25%)
Blood Creatine Phosphokinase Increa...
13 (.23%)
Chills
13 (.23%)
Contusion
13 (.23%)
Feeling Hot
13 (.23%)
Lacrimation Increased
13 (.23%)
Muscle Tightness
13 (.23%)
Off Label Use
13 (.23%)
Paralysis
13 (.23%)
Pruritus
13 (.23%)
Rhinorrhoea
13 (.23%)
Vocal Cord Paralysis
13 (.23%)
Abasia
12 (.21%)
Cardio-respiratory Arrest
12 (.21%)
Cough
12 (.21%)

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This graph shows the top adverse events submitted to the FDA for Botulinum Toxin Type A, 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 Botulinum Toxin Type A 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 Botulinum Toxin Type A

What are the most common Botulinum Toxin Type A adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Botulinum Toxin Type A, 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 Botulinum Toxin Type A 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 Botulinum Toxin Type A According to Those Reporting Adverse Events

Why are people taking Botulinum Toxin Type A, according to those reporting adverse events to the FDA?

Torticollis
199
Skin Wrinkling
166
Product Used For Unknown Indication
159
Muscle Spasticity
145
Migraine
142
Hypertonic Bladder
86
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Hyperhidrosis
66
Blepharospasm
47
Dystonia
43
Drug Use For Unknown Indication
34
Muscle Spasms
30
Off Label Use
27
Neurogenic Bladder
25
Headache
21
Back Pain
16
Cerebral Palsy
15
Skin Cosmetic Procedure
11
Facial Spasm
10
Muscle Hypertrophy
9
Salivary Hypersecretion
9
Oesophageal Achalasia
9
Pain In Extremity
8
Muscle Tightness
8
Urinary Incontinence
7
Drooling
7
Leukodystrophy
6
Pain
6
Cystitis Interstitial
6
Hemiplegia
6
Head Titubation
6
Myalgia
5
Impaired Gastric Emptying
4
Anal Fissure
4
Neck Pain
4
Tension Headache
4
Fibromyalgia
4
Temporomandibular Joint Syndrome
4
Muscle Disorder
4
Bladder Pain
4
Keratitis
3
Strabismus
3
Pain In Jaw
3
Oromandibular Dystonia
3
Cerebrovascular Accident
3
Haemorrhoid Operation
3
Postoperative Care
3
Bruxism
3
Pelvic Pain
3
Dyskinesia
3
Piriformis Syndrome
3
Tremor
3

Botulinum Toxin Type A Case Reports

What Botulinum Toxin Type A 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 Botulinum Toxin Type A. 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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