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 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 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 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 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 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 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 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 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
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 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 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 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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