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Botox (Botulinum Toxin Type A) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Botox (Botulinum Toxin Type A) 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 (142)
Death (20)
Life Threatening Events (12)
Disability (8)

Reports by Reaction Type

Headache (14)Dysphagia (14)Vision Blurred (12)Fatigue (10)Eyelid Ptosis (10)Dyspnoea (10)Anxiety (10)Muscular Weakness (9)Respiratory Disorder (8)Pyrexia (8)Influenza Like Illness (8)Asthenia (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Botox (Botulinum Toxin Type A). For a complete list or a specific selection of reports, please use the links above.

Possible Botox side effects in 85 year old male

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

Patient: 85 year old male

Reactions: Acute Pulmonary Oedema, Skin Exfoliation, Condition Aggravated, Eczema

Adverse event resulted in: death

Drug(s) suspected as cause:
Botox

Other drugs received by patient: Zonisamide; Micardis; Famostagine-D; Furosemide



Possible Botox side effects in 40 year old male

Reported by a physician from France on 2012-08-22

Patient: 40 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Botox
    Dosage: 50 units, single
    Start date: 2012-07-30
    End date: 2012-07-30

Botox
    Dosage: 200 units, single
    Start date: 2012-07-30
    End date: 2012-07-30

Botox
    Dosage: 100 units, single
    Indication: Muscle Spasticity
    Start date: 2012-07-30
    End date: 2012-07-30

Other drugs received by patient: Nebivolol; Perindopril Erbumine; Clonazepam; Escitalopram; Lioresal



Possible Botox side effects in 33 year old female

Reported by a physician from Japan on 2012-08-20

Patient: 33 year old female

Reactions: Vomiting, Dysphagia, Heterophoria, Nystagmus, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox

Other drugs received by patient: Depakene



Possible Botox side effects in 3 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 3 year old female

Reactions: Increased Tendency To Bruise, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox

Other drugs received by patient: Thiopental Sodium; Diprivan



Possible Botox side effects in 76 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 76 year old female

Reactions: Back Pain, Oliguria, Pleural Effusion, Pyrexia, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox

Other drugs received by patient: Myonal; Famotidine; Akineton



Possible Botox side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: female

Reactions: Nonspecific Reaction, Visual Impairment, Vision Blurred

Drug(s) suspected as cause:
Botox



Possible Botox side effects in female

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

Patient: female

Reactions: Eyelid Oedema, Swelling, Muscular Weakness, Eyelid Ptosis

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 33 year old female

Reported by a physician from Japan on 2012-08-08

Patient: 33 year old female

Reactions: Vomiting, Dysphagia, Nystagmus, Heterophoria, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox

Other drugs received by patient: Depakene



Possible Botox side effects in 3 year old female

Reported by a physician from Japan on 2012-08-08

Patient: 3 year old female

Reactions: Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 2 year old male

Reported by a consumer/non-health professional from France on 2012-08-01

Patient: 2 year old male, weighing 25.2 kg (55.4 pounds)

Reactions: Status Epilepticus, Pyrexia, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox
    Dosage: unk
    Start date: 2010-11-22
    End date: 2010-11-22

Botox
    Dosage: unk
    Start date: 2011-06-07
    End date: 2011-06-07

Botox
    Dosage: 300 units, unk
    Indication: Muscle Spasticity
    Start date: 2012-05-09
    End date: 2012-05-09

Botox
    Dosage: unk
    Start date: 2011-11-22
    End date: 2011-11-22



Possible Botox side effects in 28 year old female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: 28 year old female, weighing 47.6 kg (104.8 pounds)

Reactions: Ear Discomfort, Anxiety, Migraine, Tinnitus, Deafness Unilateral, Cognitive Disorder, Headache

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Botox



Possible Botox side effects in female

Reported by a consumer/non-health professional from Japan on 2012-08-01

Patient: female

Reactions: Haemorrhage Subcutaneous

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 76 year old female

Reported by a physician from Japan on 2012-07-27

Patient: 76 year old female

Reactions: Urine Output Decreased, Pyrexia, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 53 year old female

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

Patient: 53 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Migraine, Vomiting, Nausea, Urinary Tract Infection, Injection Site Pain, Eye Infection, Abdominal Pain Upper, Anxiety, Myalgia, NO Therapeutic Response, Kidney Infection, Sinusitis, Influenza Like Illness

Drug(s) suspected as cause:
Botox
    Indication: Pain
    Start date: 2012-02-12
    End date: 2012-07-12

Botox
    Indication: Temporomandibular Joint Syndrome
    Start date: 2012-02-12
    End date: 2012-07-12



Possible Botox side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 67 year old male

Reactions: Diplopia, Respiratory Disorder, Dysphagia, Head Injury, Dysphonia, Muscular Weakness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Botox
    Dosage: 15 units, single
    Indication: Facial Spasm
    Start date: 2012-03-30
    End date: 2012-03-30

Dysport
    Dosage: 150 units, single
    Indication: Muscle Spasms
    Start date: 2012-03-30
    End date: 2012-03-30

Other drugs received by patient: Mianserine; Pramipexole Dihydrochloride; Modopar Gel Levodopa; Dihydroergotamine Mesylate; Amantadine HCL; Thiocolchicoside; Madopar Dispersibl; Polyethylene Glycol; Trospium Chloride



Possible Botox side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: 52 year old female, weighing 80.3 kg (176.6 pounds)

Reactions: Anxiety, Dyspnoea Exertional, Respiratory Disorder, Wheezing, Total Lung Capacity Decreased, Cough

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Botox



Possible Botox side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-12

Patient: female

Reactions: Sensation of Heaviness, Eyelid Disorder, Vision Blurred

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 67 year old male

Reported by a consumer/non-health professional from France on 2012-07-09

Patient: 67 year old male

Reactions: Diplopia, Respiratory Disorder, Dysphagia, Dysphonia, Head Injury, Muscular Weakness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Botox
    Dosage: 15 units, single
    Indication: Facial Spasm
    Start date: 2012-03-30
    End date: 2012-03-30

Dysport
    Dosage: 150 units, single
    Indication: Muscle Spasms
    Start date: 2012-03-30
    End date: 2012-03-30

Other drugs received by patient: Forlax; Amantadine HCL; Mianserine; Trospium Chloride; Modopar Gel Levodopa; Pramipexole Dihydrochloride; Dihydroergotamine Mesylate; Madopar Dispersibl; Thiocolchicoside



Possible Botox side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 55 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Fear, Wheezing, Visual Acuity Reduced, Disorientation, Throat Tightness, Speech Disorder, Malaise, Fatigue, Thinking Abnormal, Palpitations, Dizziness, Eyelid Ptosis, Depression, Cough, Migraine, Dyspnoea, Indifference, Paraesthesia, Dysgeusia, Panic Attack, Dysphonia, Vision Blurred

Drug(s) suspected as cause:
Botox



Possible Botox side effects in

Reported by a pharmacist from Japan on 2012-07-05

Patient:

Reactions: Hepatic Function Abnormal

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 84 year old

Reported by a physician from Japan on 2012-07-03

Patient: 84 year old

Reactions: Pneumonia Aspiration, Pyrexia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Botox
    Indication: Muscle Contracture

Botox
    Dosage: 50 units, single
    Indication: Muscle Spasms
    Start date: 2012-05-12
    End date: 2012-05-12

Other drugs received by patient: Famoditine; Furosemide; Maglax



Possible Botox side effects in 72 year old female

Reported by a consumer/non-health professional from Japan on 2012-07-03

Patient: 72 year old female

Reactions: Incorrect Route of Drug Administration, Punctate Keratitis

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-02

Patient: 23 year old female

Reactions: Abdominal Pain, Fatigue, Vomiting, Pyrexia, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox



Possible Botox side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Eye Swelling, Headache, Lacrimation Increased

Drug(s) suspected as cause:
Botox



Possible Botox side effects in

Reported by a individual with unspecified qualification from United States on 2012-06-28

Patient:

Reactions: Eyelid Oedema, Injection Site Haematoma, Injection Site Haemorrhage, Vision Blurred, Eyelid Ptosis

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 36 year old male

Reported by a physician from Japan on 2012-06-27

Patient: 36 year old male

Reactions: Joint Dislocation

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Botox
    Dosage: 50 units, single
    Indication: Muscle Spasms
    Start date: 2011-03-28
    End date: 2011-03-28

Botox
    Dosage: 50 units, single
    Start date: 2010-12-20
    End date: 2010-12-20

Other drugs received by patient: Myonal; Myonal



Possible Botox side effects in 72 year old female

Reported by a consumer/non-health professional from Japan on 2012-06-26

Patient: 72 year old female

Reactions: Punctate Keratitis, Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 70 year old female

Reported by a physician from Japan on 2012-06-22

Patient: 70 year old female

Reactions: Dysarthria, Arthralgia, Blood Creatine Phosphokinase Abnormal, Rash, Asthenia, Fall, Blood Lactate Dehydrogenase Abnormal

Drug(s) suspected as cause:
Botox



Possible Botox side effects in 82 year old

Reported by a physician from Japan on 2012-06-21

Patient: 82 year old

Reactions: Death, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Botox



Possible Botox side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-20

Patient: female, weighing 74.8 kg (164.7 pounds)

Reactions: Nonspecific Reaction, Swollen Tongue, Hypoaesthesia, Transient Ischaemic Attack, Asthenia, Muscle Spasms, Tremor

Drug(s) suspected as cause:
Botox

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