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Botox Cosmetic (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 Cosmetic (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 (2551)
Life Threatening Events (2)
Disability (7)

Reports by Reaction Type

Drug Ineffective (1232)Therapeutic Response Decreased (381)Wrong Technique in Drug Usage Process (308)Eyelid Ptosis (206)Injection Site Pain (138)Headache (123)Facial Paresis (78)Vision Blurred (59)Swelling Face (57)Injection Site Swelling (49)Dizziness (47)Nausea (46)

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

Possible Botox Cosmetic side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: DRY Mouth, Dizziness, Hypoaesthesia, Throat Tightness

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 24 units, glabella and forehead single
    Indication: Skin Wrinkling
    Start date: 2012-08-08
    End date: 2012-08-08

Botox Cosmetic



Possible Botox Cosmetic side effects in 38 year old female

Reported by a physician from United States on 2012-08-02

Patient: 38 year old female

Reactions: Chest Discomfort, Nausea, Presyncope, Tonic Clonic Movements, Dizziness, Injection Site Swelling, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox Cosmetic



Possible Botox Cosmetic side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: female

Reactions: Eyelid Ptosis, Eye Swelling

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 25 units, single
    Indication: Skin Wrinkling
    Start date: 2011-06-23

Latisse
    Dosage: 1 gtt, qhs
    Administration route: Topical
    Indication: Growth of Eyelashes
    Start date: 2011-06-28
    End date: 2011-07-01



Possible Botox Cosmetic side effects in 39 year old female

Reported by a physician from United States on 2012-07-26

Patient: 39 year old female

Reactions: Chills, Headache, Pyrexia, Abdominal Pain Upper, Myalgia, Abdominal Discomfort, Fatigue, Sinusitis, Muscle Spasms, Nausea, Hypoaesthesia, Paraesthesia, Hyperaesthesia, Panic Attack, Vision Blurred, Immune System Disorder, Respiratory Tract Infection, Feeling Abnormal, Asthenia, Influenza Like Illness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Botox Cosmetic

Other drugs received by patient: Allegra; Nasacort



Possible Botox Cosmetic side effects in 39 year old female

Reported by a physician from United States on 2012-07-18

Patient: 39 year old female

Reactions: Chills, Headache, Pyrexia, Abdominal Pain Upper, Abdominal Discomfort, Myalgia, Fatigue, Sinusitis, Muscle Spasms, Nausea, Hypoaesthesia, Paraesthesia, Panic Attack, Hyperaesthesia, Vision Blurred, Immune System Disorder, Asthenia, Respiratory Tract Infection, Feeling Abnormal, Influenza Like Illness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Botox Cosmetic

Other drugs received by patient: Nasacort; Allegra



Possible Botox Cosmetic side effects in 30 year old female

Reported by a physician from United States on 2012-07-18

Patient: 30 year old female

Reactions: Road Traffic Accident, Nausea, Dizziness, Loss of Consciousness

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 40 units, single
    Indication: Skin Wrinkling
    Start date: 2012-07-12
    End date: 2012-07-12

Botox Cosmetic



Possible Botox Cosmetic side effects in 32 year old female

Reported by a physician from United States on 2012-07-02

Patient: 32 year old female

Reactions: Migraine, Weight Decreased, Dyspnoea, Headache, Local Swelling, Panic Attack, Fatigue, Pharyngeal Oedema, Sensation of Foreign Body, Dysphonia, Palpitations, Sinus Disorder, Immune System Disorder, Heart Rate Irregular, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox Cosmetic

Botox Cosmetic
    Dosage: 28 units, single
    Indication: Skin Wrinkling
    Start date: 2012-02-14
    End date: 2012-02-14



Possible Botox Cosmetic side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27

Patient: 61 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Anaphylactic Reaction, Dizziness, Throat Tightness, Stress, Cough

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: unk
    Start date: 2011-09-30
    End date: 2011-09-30

Botox Cosmetic
    Dosage: unk
    Start date: 2011-05-12
    End date: 2011-05-12

Botox Cosmetic
    Dosage: unk
    Start date: 2011-08-22
    End date: 2011-08-22

Botox Cosmetic
    Dosage: 24 units, single
    Indication: Skin Wrinkling
    Start date: 2012-01-09
    End date: 2012-01-09



Possible Botox Cosmetic side effects in 32 year old female

Reported by a physician from United States on 2012-06-15

Patient: 32 year old female

Reactions: Weight Decreased, Migraine, Dyspnoea, Headache, Local Swelling, Sensation of Foreign Body, Panic Attack, Pharyngeal Oedema, Fatigue, Palpitations, Dysphonia, Sinus Disorder, Heart Rate Irregular, Immune System Disorder, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 28 units, single
    Indication: Skin Wrinkling
    Start date: 2012-02-14
    End date: 2012-02-14

Botox Cosmetic



Possible Botox Cosmetic side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: 39 year old female

Reactions: Chills, Pyrexia, Headache, Abdominal Pain Upper, Myalgia, Abdominal Discomfort, Fatigue, Sinusitis, Muscle Spasms, Nausea, Hypoaesthesia, Paraesthesia, Panic Attack, Hyperaesthesia, Vision Blurred, Immune System Disorder, Asthenia, Respiratory Tract Infection, Feeling Abnormal, Influenza Like Illness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Botox Cosmetic

Other drugs received by patient: Nasacort; Allegra



Possible Botox Cosmetic side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: female

Reactions: Coma

Drug(s) suspected as cause:
Botox Cosmetic



Possible Botox Cosmetic side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 53 year old female

Reactions: Vision Blurred, Eyelid Ptosis

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 24 units, unk
    Indication: Skin Wrinkling
    Start date: 2011-11-23
    End date: 2011-11-23

Botox Cosmetic
    Indication: Skin Cosmetic Procedure

Botox Cosmetic
    Dosage: unk
    Start date: 2011-08-23
    End date: 2011-08-23



Possible Botox Cosmetic side effects in 46 year old female

Reported by a physician from United States on 2012-06-04

Patient: 46 year old female

Reactions: Chest Pain, Hemiplegia

Drug(s) suspected as cause:
Botox Cosmetic

Botox Cosmetic
    Dosage: 35 units, single
    Indication: Skin Wrinkling
    Start date: 2011-09-09
    End date: 2011-09-09

Botox Cosmetic

Other drugs received by patient: Contraceptives NOS



Possible Botox Cosmetic side effects in 61 year old female

Reported by a physician from United States on 2012-05-30

Patient: 61 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Circumoral Oedema, Swelling Face, Hypersensitivity, Pruritus, Eye Swelling

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 24 units, single
    Indication: Skin Wrinkling
    Start date: 2012-03-14
    End date: 2012-03-14

Botox Cosmetic
    Dosage: unk
    Start date: 2011-09-06
    End date: 2011-09-06

Botox Cosmetic
    Dosage: unk
    Start date: 2011-02-28
    End date: 2011-02-28



Possible Botox Cosmetic side effects in 47 year old female

Reported by a physician from United States on 2012-05-30

Patient: 47 year old female

Reactions: Pruritus, Urinary Incontinence, Polyuria, Hypotonic Urinary Bladder, Erythema, Throat Tightness, Myalgia, Dyspepsia, DRY Mouth, Eyelid Ptosis, Dizziness, Musculoskeletal Stiffness, Lethargy, Cough, Polydipsia, Chest Discomfort, Dyspnoea, Nausea, Pain in Extremity, Muscular Weakness, Paraesthesia, Anxiety, Dysuria, Gastrointestinal Disorder, Vision Blurred, DRY Eye, Influenza

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 45 units, single
    Indication: Skin Wrinkling
    Start date: 2012-04-24
    End date: 2012-04-24

Botox Cosmetic

Botox Cosmetic



Possible Botox Cosmetic side effects in 63 year old female

Reported by a physician from United States on 2012-05-25

Patient: 63 year old female

Reactions: Eyelid Oedema, Weight Decreased, Aphagia, Dyspnoea, Swelling Face, Nausea, Headache, Eye Pain, Blood Potassium Decreased, Oedema Peripheral, Chest Pain, Hypothyroidism, Eyelid Ptosis, Depression, Panic Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox Cosmetic

Other drugs received by patient: Potassium Chloride; Thyroid TAB; Xanax



Possible Botox Cosmetic side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: 53 year old female

Reactions: Eyelid Ptosis, Blindness Unilateral

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 24 units, unk
    Indication: Skin Wrinkling
    Start date: 2011-11-23
    End date: 2011-11-23

Botox Cosmetic
    Dosage: unk
    Start date: 2011-08-23
    End date: 2011-08-23

Botox Cosmetic
    Indication: Skin Cosmetic Procedure



Possible Botox Cosmetic side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: female

Reactions: Dyspnoea, Diarrhoea, Asthenia, Influenza Like Illness

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: unk
    Indication: Skin Wrinkling
    Start date: 2012-04-01
    End date: 2012-04-01

Botox Cosmetic

Other drugs received by patient: Aminoglycosides (Unspecified)



Possible Botox Cosmetic side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: 44 year old female

Reactions: Dyspnoea, Drug Hypersensitivity, Muscular Weakness, Hypoaesthesia, Aptyalism, Paraesthesia, Fatigue, Facial Paresis, Lacrimation Decreased

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 28 units, single
    Start date: 2011-11-17
    End date: 2011-11-17

Botox Cosmetic
    Dosage: 22 units, single
    Indication: Skin Wrinkling
    Start date: 2009-01-22
    End date: 2009-01-22

Botox Cosmetic
    Dosage: 28 units, single
    Start date: 2012-04-10
    End date: 2012-04-10



Possible Botox Cosmetic side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: female

Reactions: Photophobia, Ocular Hyperaemia, Eye Infection, Eye Pain

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: unk
    Indication: Skin Wrinkling
    Start date: 2012-04-01
    End date: 2012-04-01

Botox Cosmetic



Possible Botox Cosmetic side effects in 43 year old female

Reported by a physician from United States on 2012-05-16

Patient: 43 year old female

Reactions: Wrong Technique in Drug Usage Process, Hepatitis C Virus Test Positive, Product Contamination

Drug(s) suspected as cause:
Botox Cosmetic

Botox Cosmetic

Botox Cosmetic
    Dosage: 40 units, single
    Indication: Skin Wrinkling
    Start date: 2012-03-29
    End date: 2012-03-29



Possible Botox Cosmetic side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: 61 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Anaphylactic Reaction, Dizziness, Throat Tightness, Stress, Cough

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: unk
    Start date: 2011-09-30
    End date: 2011-09-30

Botox Cosmetic
    Dosage: unk
    Start date: 2011-08-22
    End date: 2011-08-22

Botox Cosmetic
    Dosage: unk
    Start date: 2011-05-12
    End date: 2011-05-12

Botox Cosmetic
    Dosage: 24 units, single
    Indication: Skin Wrinkling
    Start date: 2012-01-09
    End date: 2012-01-09



Possible Botox Cosmetic side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: 40 year old female

Reactions: Submandibular Mass, Haemophilus Test Positive, Corynebacterium Test Positive, Synovial Cyst

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: unk
    Indication: Skin Wrinkling
    Start date: 2011-01-01
    End date: 2011-01-01

Dysport
    Indication: Skin Wrinkling

Other drugs received by patient: Synthroid



Possible Botox Cosmetic side effects in 55 year old female

Reported by a physician from United States on 2012-05-09

Patient: 55 year old female

Reactions: Bedridden, Dyspnoea, Spinal Pain, Pain, Visual Acuity Reduced, Headache, Facial Spasm, Tremor, Periorbital Haematoma, Malaise, Neck Pain, Activities of Daily Living Impaired, Vision Blurred, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Botox Cosmetic



Possible Botox Cosmetic side effects in 38 year old female

Reported by a physician from United States on 2012-05-09

Patient: 38 year old female

Reactions: Chest Discomfort, Nausea, Presyncope, Dizziness, Tonic Clonic Movements, Injection Site Swelling, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox Cosmetic



Possible Botox Cosmetic side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20

Patient: 46 year old female

Reactions: Chest Pain, Hemiplegia

Drug(s) suspected as cause:
Botox Cosmetic

Botox Cosmetic
    Dosage: 35 units, single
    Indication: Skin Wrinkling
    Start date: 2011-09-09
    End date: 2011-09-09

Botox Cosmetic

Other drugs received by patient: Contraceptives NOS



Possible Botox Cosmetic side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-04-17

Patient: 66 year old female, weighing 70.7 kg (155.6 pounds)

Reactions: Wrong Technique in Drug Usage Process, Chest Pain, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 45 units, single
    Indication: Skin Wrinkling
    Start date: 2012-02-03
    End date: 2012-02-03

Botox Cosmetic
    Dosage: unk
    Start date: 2009-06-24
    End date: 2009-06-24

Botox Cosmetic
    Dosage: unk
    Start date: 2008-05-07
    End date: 2008-05-07

Botox Cosmetic
    Dosage: unk
    Start date: 2012-01-24
    End date: 2012-01-24

Botox Cosmetic
    Dosage: unk
    Start date: 2008-12-12
    End date: 2008-12-12

Botox Cosmetic
    Dosage: unk
    Start date: 2011-01-26
    End date: 2011-01-26

Botox Cosmetic
    Dosage: unk
    Start date: 2010-12-29
    End date: 2010-12-29

Botox Cosmetic
    Dosage: unk
    Start date: 2010-05-18
    End date: 2010-05-18

Botox Cosmetic
    Dosage: unk
    Start date: 2007-05-30
    End date: 2007-05-30



Possible Botox Cosmetic side effects in 41 year old female

Reported by a physician from United States on 2012-04-12

Patient: 41 year old female

Reactions: Wrong Technique in Drug Usage Process, Deafness Unilateral

Drug(s) suspected as cause:
Botox Cosmetic



Possible Botox Cosmetic side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-10

Patient: 66 year old female, weighing 70.7 kg (155.6 pounds)

Reactions: Wrong Technique in Drug Usage Process, Chest Pain, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: 45 units, single
    Indication: Skin Wrinkling
    Start date: 2012-02-03
    End date: 2012-02-03

Botox Cosmetic
    Dosage: unk
    Start date: 2010-05-18
    End date: 2010-05-18

Botox Cosmetic
    Dosage: unk
    Start date: 2010-12-29
    End date: 2010-12-29

Botox Cosmetic
    Dosage: unk
    Start date: 2007-05-30
    End date: 2007-05-30

Botox Cosmetic
    Dosage: unk
    Start date: 2012-01-24
    End date: 2012-01-24

Botox Cosmetic
    Dosage: unk
    Start date: 2009-06-24
    End date: 2009-06-24

Botox Cosmetic
    Dosage: unk
    Start date: 2011-01-26
    End date: 2011-01-26

Botox Cosmetic
    Dosage: unk
    Start date: 2008-12-12
    End date: 2008-12-12

Botox Cosmetic
    Dosage: unk
    Start date: 2008-05-07
    End date: 2008-05-07



Possible Botox Cosmetic side effects in 61 year old female

Reported by a physician from United States on 2012-04-09

Patient: 61 year old female

Reactions: Circumoral Oedema, Swelling Face, Hypersensitivity, Pruritus, Eye Swelling

Drug(s) suspected as cause:
Botox Cosmetic

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