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 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 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 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 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 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 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 32 year old female
Reported by a consumer/non-health professional from United States on 2012-04-09
Patient: 32 year old female
Reactions: Malaise, Lymphadenopathy, Vocal Cord Paralysis, Headache, Aphonia
Drug(s) suspected as cause:
Botox Cosmetic
Dosage: unk
Indication: Skin Wrinkling
Start date: 2011-12-01
End date: 2011-12-01
Botox Cosmetic
Botox Cosmetic
Other drugs received by patient: Zyrtec
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