DrugCite
Search

BOTOX COSMETIC

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Botox Cosmetic Adverse Events Reported to the FDA Over Time

How are Botox Cosmetic adverse event reports trending over time?

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

Most Common Botox Cosmetic Adverse Events Reported to the FDA

What are the most common Botox Cosmetic adverse events reported to the FDA?

Drug Ineffective
4886 (24.24%)
Therapeutic Response Decreased
988 (4.9%)
Eyelid Ptosis
981 (4.87%)
Wrong Technique In Drug Usage Proce...
756 (3.75%)
Headache
540 (2.68%)
Injection Site Pain
502 (2.49%)
Facial Paresis
332 (1.65%)
Vision Blurred
259 (1.28%)
Nausea
253 (1.26%)
Dizziness
236 (1.17%)
Swelling Face
229 (1.14%)
Show More Show More
Injection Site Swelling
202 (1%)
Eyelid Oedema
181 (.9%)
Influenza Like Illness
179 (.89%)
Fatigue
175 (.87%)
Dyspnoea
164 (.81%)
Muscular Weakness
163 (.81%)
Paraesthesia
159 (.79%)
Dysphagia
152 (.75%)
Asthenia
148 (.73%)
Hypoaesthesia
144 (.71%)
Eye Swelling
133 (.66%)
Anxiety
121 (.6%)
Diplopia
101 (.5%)
Rash
96 (.48%)
Pain
94 (.47%)
Erythema
92 (.46%)
Pyrexia
91 (.45%)
Injection Site Erythema
89 (.44%)
Hypersensitivity
85 (.42%)
Injection Site Haematoma
84 (.42%)
Skin Tightness
83 (.41%)
Muscle Spasms
81 (.4%)
Myalgia
81 (.4%)
Dry Eye
80 (.4%)
Hypoaesthesia Facial
75 (.37%)
Palpitations
74 (.37%)
Urticaria
72 (.36%)
Contusion
70 (.35%)
Eye Pain
70 (.35%)
Injection Site Reaction
68 (.34%)
Insomnia
67 (.33%)
Dry Mouth
66 (.33%)
Pruritus
66 (.33%)
Skin Disorder
66 (.33%)
Facial Pain
63 (.31%)
Facial Palsy
62 (.31%)
Neck Pain
62 (.31%)
Throat Tightness
61 (.3%)
Muscle Twitching
60 (.3%)
Malaise
59 (.29%)
Migraine
59 (.29%)
Periorbital Oedema
59 (.29%)
Sinusitis
58 (.29%)
Ocular Hyperaemia
57 (.28%)
Dysphonia
56 (.28%)
Injection Site Rash
56 (.28%)
Burning Sensation
55 (.27%)
Hyperhidrosis
55 (.27%)
Weight Decreased
55 (.27%)
Chest Pain
53 (.26%)
Cough
53 (.26%)
Eye Irritation
53 (.26%)
Pain In Extremity
52 (.26%)
Vomiting
50 (.25%)
Dysarthria
48 (.24%)
Influenza
48 (.24%)
Heart Rate Increased
47 (.23%)
Vertigo
47 (.23%)
Arthralgia
46 (.23%)
Feeling Abnormal
44 (.22%)
Sensory Disturbance
44 (.22%)
Chills
43 (.21%)
Depression
43 (.21%)
Tremor
43 (.21%)
Visual Impairment
43 (.21%)
Chest Discomfort
42 (.21%)
Hypoaesthesia Oral
42 (.21%)
Injection Site Pruritus
41 (.2%)
Diarrhoea
40 (.2%)
Speech Disorder
40 (.2%)
Swollen Tongue
39 (.19%)
Back Pain
38 (.19%)
Visual Acuity Reduced
37 (.18%)
Lacrimation Increased
36 (.18%)
Oropharyngeal Pain
36 (.18%)
Skin Wrinkling
36 (.18%)
Face Oedema
35 (.17%)
Musculoskeletal Stiffness
35 (.17%)
Myasthenia Gravis
35 (.17%)
Blood Creatine Phosphokinase Increa...
34 (.17%)
Muscle Tightness
33 (.16%)
Botulism
32 (.16%)
Decreased Appetite
32 (.16%)
Abnormal Sensation In Eye
31 (.15%)
Asthenopia
31 (.15%)
Loss Of Consciousness
31 (.15%)
Viith Nerve Paralysis
31 (.15%)
Lip Swelling
30 (.15%)
Eye Pruritus
29 (.14%)
Injection Site Mass
29 (.14%)

ExportShare/Embed GraphExport Export Data

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

What are the most common Botox Cosmetic adverse events reported to the FDA?

Show More Show More

ExportShare/Embed Graph Export Export Data

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

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

Skin Wrinkling
8514
Product Used For Unknown Indication
167
Hyperhidrosis
53
Drug Use For Unknown Indication
49
Skin Cosmetic Procedure
19
Migraine
19
Show More Show More
Headache
10
Blepharospasm
7
Skin Tightness
5
Temporomandibular Joint Syndrome
5
Muscle Spasticity
5
Accidental Exposure
5
Skin Disorder
4
Drug Exposure During Pregnancy
4
Torticollis
3
Tension Headache
3
Face Lift
3
Eyelid Ptosis
2
Alopecia
2
Skin Atrophy
2
Facial Paresis
2
Pain
2
Muscle Hypertrophy
2
Brachycephaly
2
Muscle Spasms
2
Tremor
1
Cluster Headache
1
Mass
1
Injection Site Anaesthesia
1
Arthralgia
1
Drug Exposure Via Breast Milk
1
Lip Swelling
1
Mucopolysaccharidosis
1
Scar
1
Back Disorder
1
Thoracic Outlet Syndrome
1
Cerebral Palsy
1
Off Label Use
1
Pain In Jaw
1
Back Pain
1
Quadriplegia
1

Drug Labels

LabelLabelerEffective
Botox Cosmetic Allergan, Inc. 15-NOV-12

Botox Cosmetic Case Reports

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

Powered by Google

About Results

This report contains aggregated drug side effects and adverse events for Botox Cosmetic. 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.

Comments

Share your experience with Botox Cosmetic.