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Botox (Botulinum Toxin Type A) - Side Effects & Adverse Reactions Reported to FDA

 



This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Botox (Botulinum Toxin Type A). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.

Our database includes reports primarily from April 2009 to March 2010. The information is not vetted and should not be cosidered as verified clinical evidence.

All cases (986)
     Drug Ineffective (219)Muscular Weakness (151)Dysphagia (116)more >>

Cases resulting in a serious event (497)
     Muscular Weakness (129)Dysphagia (113)Asthenia (60)more >>

Cases resulting in death (36)
     Dysphagia (7)Muscular Weakness (6)Weight Decreased (4)more >>

Cases resulting in life threatening events (14)
     Dysphagia (4)Unresponsive TO Stimuli (3)Areflexia (3)more >>

Cases resulting in hospitalization (151)
     Dysphagia (51)Muscular Weakness (33)Asthenia (21)more >>

Cases resulting in disability (51)
     Muscular Weakness (22)Dysphagia (11)Vision Blurred (11)more >>

Cases resulting in other serious reactions (360)
     Muscular Weakness (119)Dysphagia (88)Asthenia (47)more >>

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

Possible Botox side effects / adverse reactions in 45 year old female

Reported by a individual with unspecified qualification from United States on 2010-03-31

Patient: 45 year old female, weighing 44.0 kg (96.8 pounds)

Reactions: Weight Decreased, Dysphagia, Malnutrition, Headache, Foreign Body, Throat Tightness, Skin Tightness, Loss of Consciousness, Panic Attack, Eyelid Function Disorder, Eye Burns, Musculoskeletal Stiffness, Asthenia, Muscle Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 18 year old female

Reported by a physician from France on 2010-03-25

Patient: 18 year old female

Reactions: Nervous System Disorder, Headache, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox
    Dosage: unk
    Indication: Hyperhidrosis
    Start date: 2010-01-11
    End date: 2010-01-11

Botox
    Dosage: 100 units, single
    Start date: 2009-04-01
    End date: 2009-04-01



Possible Botox side effects / adverse reactions in female

Reported by a physician from Australia on 2010-03-25

Patient: female

Reactions: Hypoaesthesia Facial, Headache

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 61 year old female

Reported by a physician from South Africa on 2010-03-25

Patient: 61 year old female

Reactions: Vasculitis

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Botox

Other drugs received by patient: Juvederm Ultra; Warfarin Sodium



Possible Botox side effects / adverse reactions in 70 year old female

Reported by a physician from United States on 2010-03-25

Patient: 70 year old female

Reactions: Speech Disorder, Dyspnoea

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox

Other drugs received by patient: Kapidex; Prozac; Synthroid; Diovan HCT; Zetia; Tylenol-500; Aleve (Caplet); Simtom Silver; Aspirin; Citracal-D; Lutein; Vitamin-Mineral Compound TAB; Iron; Vitamin D; Fish OIL



Possible Botox side effects / adverse reactions in 23 year old male

Reported by a physician from France on 2010-03-22

Patient: 23 year old male

Reactions: Epilepsy

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox

Other drugs received by patient: Depakene; Mysoline



Possible Botox side effects / adverse reactions in female

Reported by a physician from South Africa on 2010-03-22

Patient: female

Reactions: Phlebitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox

Other drugs received by patient: Juvederm Ultra



Possible Botox side effects / adverse reactions in 24 year old female

Reported by a physician from Netherlands on 2010-03-22

Patient: 24 year old female

Reactions: Dysphagia

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 44 year old female

Reported by a physician from Canada on 2010-03-22

Patient: 44 year old female

Reactions: Sepsis, Hypertensive Crisis

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 70 year old female

Reported by a physician from United States on 2010-03-18

Patient: 70 year old female

Reactions: Speech Disorder, Dyspnoea

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox

Other drugs received by patient: Prozac; Synthroid; Diovan HCT; Zetia; Capadex; Tylenol-500; Aleve (Caplet); Simtom Silver; Aspirin; Citracal-D; Lutein; Vitamin-Mineral Compound TAB; Iron; Vitamin D; Fish OIL



Possible Botox side effects / adverse reactions in female

Reported by a health professional (non-physician/pharmacist) from United States on 2010-03-17

Patient: female

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 5 year old male

Reported by a physician from United States on 2010-03-17

Patient: 5 year old male, weighing 20.0 kg (44.0 pounds)

Reactions: Bulbar Palsy, Drooling, Dysphagia, Muscular Weakness, Constipation, Vocal Cord Disorder, Overdose, Heart Rate Decreased, Areflexia, Asthenia, Apnoea, Tracheitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox
    Dosage: 200 units (50 units x 4), single
    Indication: Muscle Spasticity
    Start date: 2008-12-17
    End date: 2008-12-17

Botox
    Indication: Hypertonia

Other drugs received by patient: Clonidine; Methadone HCL; Methadone HCL; Miralax; Enema; Ativan; Prevacid; Keppra; Morphine; Pain EEZ



Possible Botox side effects / adverse reactions in 88 year old male

Reported by a physician from United States on 2010-03-12

Patient: 88 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 36 year old male

Reported by a individual with unspecified qualification on 2010-03-12

Patient: 36 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Drug Toxicity, Muscle Spasms

Adverse event resulted in: life threatening event

Suspect drug(s):
Lidocaine
    Indication: Muscle Spasms

Lidocaine
    Dosage: 10 ml
    Indication: Pain in Extremity

Adrenaline
    Indication: Muscle Spasms

Adrenaline
    Indication: Pain in Extremity

Bupivacaine HCL
    Dosage: 20 ml
    Indication: Muscle Spasms

Bupivacaine HCL
    Indication: Pain in Extremity

Botox
    Indication: Muscle Spasms

Botox
    Indication: Pain in Extremity

Clexane
    Indication: Thrombosis Prophylaxis

Pregabalin
    Indication: Pain in Extremity

Dantrolene
    Indication: Pain in Extremity

Other drugs received by patient: Harmann's Solution; Oxygen; Intralipid 20%; Intralipid 20%



Possible Botox side effects / adverse reactions in 15 year old

Reported by a physician from United Kingdom on 2010-03-11

Patient: 15 year old , weighing 18.0 kg (39.6 pounds)

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in

Reported by a physician from Canada on 2010-03-10

Patient:

Reactions: Bronchospasm

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 56 year old female

Reported by a physician from United States on 2010-03-09

Patient: 56 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Fatigue, Asthenia

Suspect drug(s):
Botox
    Dosage: 400 units, single
    Indication: Muscle Spasticity
    Start date: 2008-09-19
    End date: 2008-09-19

Botox
    Dosage: unk, unknown
    Start date: 2007-01-01



Possible Botox side effects / adverse reactions in 78 year old female

Reported by a physician from United States on 2010-03-09

Patient: 78 year old female

Reactions: Drug Ineffective, Injection Site Pain

Suspect drug(s):
Botox
    Dosage: 100 units, single
    Indication: Parkinson's Disease
    Start date: 2008-10-06
    End date: 2008-10-06

Botox
    Indication: Torticollis

Other drugs received by patient: Tramadol HCL; Lidoderm; Paroxetine HCL; Paroxetine HCL; Fludrocort; Carbidopa + Levodopa; Aricept; Enavlex; Comtan; Fosamax; Provigil; Meclizine; Tylenol-500; Laxative



Possible Botox side effects / adverse reactions in 40 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2010-03-09

Patient: 40 year old female

Reactions: Vomiting, Facial Paresis, Contusion, Headache

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 56 year old female

Reported by a physician from United States on 2010-03-09

Patient: 56 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Fatigue, Asthenia

Suspect drug(s):
Botox
    Dosage: 400 units, single
    Indication: Muscle Spasticity
    Start date: 2008-09-19
    End date: 2008-09-19

Botox
    Dosage: unk, unknown
    Start date: 2007-01-01



Possible Botox side effects / adverse reactions in 60 year old female

Reported by a physician from United States on 2010-03-08

Patient: 60 year old female

Reactions: Muscular Weakness

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox
    Dosage: 150 units, single
    Indication: Torticollis
    Start date: 2010-02-01
    End date: 2010-02-01

Botox
    Dosage: 100 units, single
    Start date: 2009-12-01
    End date: 2009-12-01

Botox
    Dosage: 100 units, single



Possible Botox side effects / adverse reactions in 57 year old female

Reported by a physician from United States on 2010-03-08

Patient: 57 year old female

Reactions: Rash

Suspect drug(s):
Aczone
    Dosage: unk
    Administration route: Topical
    Indication: Rash
    Start date: 2009-12-10
    End date: 2009-12-11

Botox
    Indication: Drug USE FOR Unknown Indication



Possible Botox side effects / adverse reactions in 56 year old female

Reported by a physician from United States on 2010-03-08

Patient: 56 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Fatigue, Asthenia

Suspect drug(s):
Botox
    Dosage: 400 units, single
    Indication: Muscle Spasticity
    Start date: 2008-09-19
    End date: 2008-09-19

Botox
    Dosage: unk, unknown
    Start date: 2007-01-01



Possible Botox side effects / adverse reactions in

Reported by a physician from France on 2010-03-08

Patient:

Reactions: Guillain-Barre Syndrome, Polyneuropathy

Adverse event resulted in: hospitalization

Suspect drug(s):
Botox



Possible Botox side effects / adverse reactions in 67 year old female

Reported by a physician from United States on 2010-03-08

Patient: 67 year old female

Reactions: Therapeutic Response Decreased, Muscular Weakness

Suspect drug(s):
Botox
    Dosage: 180 units, single
    Indication: Blepharospasm
    Start date: 2009-02-02
    End date: 2009-02-02

Botox
    Indication: Head Titubation

Botox
    Indication: Torticollis

Other drugs received by patient: FLU Shot; Shingle Shot

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