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Botulinum FDA adverse reports: 193. View All Botulinum FDA Adverse Reports

Botulinum FDA safety alerts: 2008 2009

Reported deaths: 19

Reported hospitalizations: 99

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Botulinum Side Effects Report: 7028219-4,Cellulitis Orbital, Hypersensitivity
on Sep 17, 2010 Female patient from UNITED KINGDOM, , 52 years of age, was diagnosed with off label use, skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: cellulitis orbital, hypersensitivity. Botulinum dosage: 70 Units (70 Units, Single Cycle), Intramuscular. During the same period patient was treated with BOTULINUM TOXIN TYPE A, RESTYLANE.

Botulinum Side Effects Report: 7021690-3,Acute Coronary Syndrome, Acute Myocardial Infarction, Atrial Septal Defect, Bundle Branch Block Right, Coronary Artery Occlusion, Paradoxical Embolism, Ventricular Fibrillation
on Sep 21, 2010 Male patient from SWITZERLAND, , 56 years of age, was diagnosed with neurogenic bladder and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: acute coronary syndrome, acute myocardial infarction, atrial septal defect, bundle branch block right, coronary artery occlusion, paradoxical embolism, ventricular fibrillation. Botulinum dosage: 300 Units (300 Units, Single Cycle), Intravesical. Patient was hospitalized.

Botulinum Side Effects Report: 7003552-0,Dysphagia, Eating Disorder
on Sep 13, 2010 Male patient from JAPAN, , 48 years of age, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and dysphagia, eating disorder (What is eating disorder?). Botulinum dosage: 60 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A.

Botulinum Side Effects Report: 7003230-8,Dysphagia, Eating Disorder
on Aug 29, 2010 Male patient from JAPAN, , 48 years of age, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and dysphagia, eating disorder (What is eating disorder?). Botulinum dosage: 60 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A.


Botulinum Side Effects Report: 6979658-9,Rash, Urticaria
on Sep 10, 2010 Female patient from UNITED STATES, , weighting 108.0 lb, was diagnosed with blepharospasm and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: rash (What is rash?), urticaria. Botulinum dosage: 3 Months Injection.

Botulinum Side Effects Report: 6969027-X,Dysphagia, Eating Disorder
on Aug 29, 2010 Male patient from JAPAN, , 48 years of age, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and dysphagia, eating disorder (What is eating disorder?). Botulinum dosage: 60 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A.

Botulinum Side Effects Report: 6956260-6,Cellulitis Orbital, Hypersensitivity, Off Label Use
on Aug 11, 2010 Female patient from UNITED KINGDOM, , 52 years of age, was diagnosed with off label use, skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: cellulitis orbital, hypersensitivity, Botulinum and off label use. Botulinum dosage: 70 Units (70 Units,single Cycle),intramuscular. During the same period patient was treated with BOTULINUM TOXIN TYPE A, RESTYLANE.

Botulinum Side Effects Report: 6908170-8,Muscle Twitching
on Jul 29, 2010 Female patient from UNITED KINGDOM, , 20 years of age, weighting 104.9 lb, was diagnosed with urinary retention, dysuria and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: muscle twitching. Botulinum dosage: 100 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, OXAZEPAM. Patient was hospitalized.

Botulinum Side Effects Report: 6880309-2,Asthenia, Haematuria, Pollakiuria, Pyrexia, Urosepsis
on Jul 20, 2010 Male patient from CANADA, , 65 years of age, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and asthenia, Botulinum and haematuria, pollakiuria, Botulinum and pyrexia, urosepsis. Botulinum dosage: 200 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A. Patient was hospitalized.


Botulinum Side Effects Report: 6813515-3,Depression
on Jun 21, 2010 Female patient from CANADA, , 54 years of age, was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and depression (What is depression?). Botulinum dosage: Unk. During the same period patient was treated with CLONIDINE, LORAZEPAM, PROPRANOLOL, MEDROXYPROGESTERONE, PAXIL, OXYCODONE, DURAGESIC.

Botulinum Side Effects Report: 6810306-4,Depression
on Jun 21, 2010 Female patient from CANADA, , 66 years of age, was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and depression (What is depression?). Botulinum dosage: . During the same period patient was treated with BACLOFEN, FENTANYL, IMOVANE.

Botulinum Side Effects Report: 6787255-3,Photopsia, Vitreous Detachment, Vitreous Floaters
on Jun 08, 2010 Female patient from UNITED KINGDOM, , 39 years of age, was diagnosed with skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: photopsia, vitreous detachment, vitreous floaters. Botulinum dosage: (single Cycle), Subcutaneous. During the same period patient was treated with PROPRANOLOL, MIRTAZAPINE, DIAZEPAM.

Botulinum Side Effects Report: 6767077-X,Photopsia, Vitreous Detachment, Vitreous Floaters
on Jun 07, 2010 Female patient from UNITED KINGDOM, , 39 years of age, was diagnosed with skin wrinkling, anxiety (What is anxiety?) and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: photopsia, vitreous detachment, vitreous floaters. Botulinum dosage: Unk. During the same period patient was treated with PROPRANOLOL.

Botulinum Side Effects Report: 6762463-6,Mycobacterial Infection
on Jun 03, 2010 Female patient from CHINA, , 32 years of age, was diagnosed with skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: mycobacterial infection. Botulinum dosage: .


Botulinum Side Effects Report: 6743766-8,Asthenia, Haematuria, Pollakiuria, Pyrexia, Urosepsis
on May 25, 2010 Male patient from CANADA, , 65 years of age, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and asthenia, Botulinum and haematuria, pollakiuria, Botulinum and pyrexia, urosepsis. Botulinum dosage: Unk. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A. Patient was hospitalized.

Botulinum Side Effects Report: 6736353-9,Hip Fracture
on May 18, 2010 Female patient from CANADA, , 60 years of age, was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and hip fracture. Botulinum dosage: . Patient was hospitalized.

Botulinum Side Effects Report: 6720478-8,Apnoeic Attack, Cyanosis
on Apr 26, 2010 Male patient from JAPAN, , child 2 years of age, was diagnosed with torticollis, epilepsy (What is epilepsy?), chronic respiratory failure, gastric ulcer and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and apnoeic attack, Botulinum and cyanosis. Botulinum dosage: 92 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, PHENOBARBITAL, TEGRETOL, CLARITHROMYCIN, CARBOCISTEINE, FAMOTIDINE, AMBROXOL HYDROCHLORIDE, CLEMASTINE FUMARATE. Patient was hospitalized.

Botulinum Side Effects Report: 6720477-6,Apnoeic Attack, Cyanosis
on Apr 26, 2010 Male patient from JAPAN, , child 2 years of age, was diagnosed with torticollis, epilepsy (What is epilepsy?), chronic respiratory failure, gastric ulcer and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and apnoeic attack, Botulinum and cyanosis. Botulinum dosage: 92 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, PHENOBARBITAL, TEGRETOL, CLARITHROMYCIN, CARBOCISTEINE, FAMOTIDINE, AMBROXOL HYDROCHLORIDE, CLEMASTINE FUMARATE. Patient was hospitalized.

Botulinum Side Effects Report: 6717162-3,Chorea, Dystonia, Haemosiderosis, Injury, Nuclear Magnetic Resonance Imaging Brain Abnormal
on Apr 20, 2010 Male patient from UNITED KINGDOM, , 56 years of age, was diagnosed with ballismus and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: chorea, dystonia (What is dystonia?), haemosiderosis, injury, nuclear magnetic resonance imaging brain abnormal. Botulinum dosage: 500 Units (500 Units,). During the same period patient was treated with HALOPERIDOL, ORPHENADRINE CITRATE, TETRABENAZINE.


Botulinum Side Effects Report: 6714337-4,Apnoeic Attack, Cyanosis
on Apr 28, 2010 Male patient from JAPAN, , child 2 years of age, was diagnosed with torticollis, epilepsy (What is epilepsy?), chronic respiratory failure, gastric ulcer and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and apnoeic attack, Botulinum and cyanosis. Botulinum dosage: 92 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, PHENOBARBITAL, TEGRETOL, CLARITHROMYCIN, CARBOCISTEINE, FAMOTIDINE, AMBROXOL HYDROCHLORIDE, CLEMASTINE FUMARATE. Patient was hospitalized.

Botulinum Side Effects Report: 6711464-2,Asthenia, Haematuria, Pollakiuria, Pyrexia, Urosepsis
on Apr 28, 2010 Male patient from CANADA, , 65 years of age, was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and asthenia, Botulinum and haematuria, pollakiuria, Botulinum and pyrexia, urosepsis. Botulinum dosage: Unk. Patient was hospitalized.

Botulinum Side Effects Report: 6686002-3,Vitreous Detachment
on Mar 29, 2010 Female patient from UNITED KINGDOM, , 39 years of age, was diagnosed with skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: vitreous detachment. Botulinum dosage: Single Cycle, Subcutaneous. During the same period patient was treated with BOTULINUM TOXIN TYPE A, PROPRANOLOL, MIRTAZAPINE, DIAZEPAM.

Botulinum Side Effects Report: 6683625-2,Botulism
on Apr 05, 2010 Female patient from UNITED STATES, , 33 years of age, was diagnosed with skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and botulism (What is botulism?). Botulinum dosage: . Patient was hospitalized.

Botulinum Side Effects Report: 6660609-1,Vitreous Detachment
on Mar 26, 2010 Female patient from UNITED KINGDOM, , 39 years of age, was diagnosed with skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: vitreous detachment. Botulinum dosage: Unk.


Botulinum Side Effects Report: 6654693-9,Blood Pressure Decreased, Bradycardia, Chest Discomfort, Cold Sweat, Feeling Abnormal
on Mar 16, 2010 Male patient from JAPAN, , 67 years of age, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: blood pressure decreased, bradycardia, chest discomfort, cold sweat, Botulinum and feeling abnormal. Botulinum dosage: 130 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A.

Botulinum Side Effects Report: 6651796-X,Lip And/or Oral Cavity Cancer
on Mar 16, 2010 Male patient from GERMANY, , weighting 130.1 lb, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: lip and/or oral cavity cancer. Botulinum dosage: 100 Units, Single. Patient was hospitalized.

Botulinum Side Effects Report: 6646588-1,Swelling Face
on Mar 18, 2010 Male patient from UNITED KINGDOM, , 74 years of age, weighting 163.1 lb, was diagnosed with muscle spasticity and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: swelling face. Botulinum dosage: Unk. During the same period patient was treated with BOTULINUM TOXIN TYPE A. Patient was hospitalized.

Botulinum Side Effects Report: 6637074-3,Swelling Face
on Mar 05, 2010 Male patient from UNITED KINGDOM, , 74 years of age, weighting 163.1 lb, was diagnosed with muscle spasticity and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: swelling face. Botulinum dosage: Unk. During the same period patient was treated with BOTULINUM TOXIN TYPE A. Patient was hospitalized.

Botulinum Side Effects Report: 6626708-5,Muscular Weakness
on Mar 03, 2010 Male patient from BRAZIL, , 36 years of age, weighting 165.3 lb, was diagnosed with neurogenic bladder and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and muscular weakness. Botulinum dosage: Unk, Single. Patient was hospitalized and became disabled.


Botulinum Side Effects Report: 6619617-9,Blood Pressure Decreased, Bradycardia, Chest Discomfort, Cold Sweat, Feeling Abnormal, Shock
on Mar 03, 2010 Male patient from JAPAN, , 67 years of age, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: blood pressure decreased, bradycardia, chest discomfort, cold sweat, Botulinum and feeling abnormal, shock. Botulinum dosage: 130 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A.

Botulinum Side Effects Report: 6605074-5,Lip And/or Oral Cavity Cancer
on Feb 15, 2010 Female patient from GERMANY, , weighting 130.1 lb, was diagnosed with torticollis and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: lip and/or oral cavity cancer. Botulinum dosage: 100 Units, Single.

Botulinum Side Effects Report: 6598091-5,Type Iv Hypersensitivity Reaction
on Jan 14, 2005 Female patient from UNITED STATES, , 46 years of age, was diagnosed with skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: type iv hypersensitivity reaction. Botulinum dosage: 20units, Prn. During the same period patient was treated with INJECTABLE FILLER.

Botulinum Side Effects Report: 6596383-7,Angioedema, Dyspnoea
on Feb 22, 2010 Male patient from UNITED STATES, , 77 years of age, weighting 185.0 lb, was diagnosed with facial spasm and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: angioedema, dyspnoea. Botulinum dosage: 3.75 U Per 0.05 Ml.

Botulinum Side Effects Report: 6588978-1,Foot Deformity
on Feb 08, 2010 Male patient from CANADA, , 63 years of age, was diagnosed with muscle spasticity, cerebrovascular accident and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: foot deformity. Botulinum dosage: 200 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, ANDROGEL, LEVOTHYROXINE, LIPITOR, PREDNISONE, PANTOPRAZOLE, ENALAPRIL MALEATE, AGGRENOX.


Botulinum Side Effects Report: 6588132-3,Dysphagia, Weight Decreased
on Feb 10, 2010 Male patient from CANADA, , 51 years of age, weighting 130.0 lb, was diagnosed with muscle spasms and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and dysphagia, weight decreased. Botulinum dosage: 75 Units, Single.

Botulinum Side Effects Report: 6577967-9,Deep Vein Thrombosis, Urinary Tract Infection
on Feb 01, 2010 Male patient from UNITED STATES, , 40 years of age, was diagnosed with torticollis, muscle spasticity, pain (What is pain?), anxiety (What is anxiety?), diabetes mellitus and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: deep vein thrombosis (What is deep vein thrombosis?), Botulinum and urinary tract infection (What is urinary tract infection?). Botulinum dosage: 260 Units, Single. During the same period patient was treated with ZANAFLEX, PERCOCET, CYMBALTA, ASPART INSULIN, LANTUS. Patient was hospitalized.

Botulinum Side Effects Report: 6567767-8,Muscular Weakness
on Jan 29, 2010 Male patient from BRAZIL, , 36 years of age, weighting 165.3 lb, was diagnosed with neurogenic bladder and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: Botulinum and muscular weakness. Botulinum dosage: Unk, Single. Patient was hospitalized and became disabled.

Botulinum Side Effects Report: 6566114-5,Cardiomegaly, Diabetes Mellitus, Influenza Like Illness, Pleural Effusion
on Jan 26, 2010 Male patient from CANADA, , 80 years of age, was diagnosed with muscle spasticity and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: cardiomegaly, diabetes mellitus, influenza like illness, pleural effusion. Botulinum dosage: 200 Units, Unk. During the same period patient was treated with BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, INSULIN, ACCUPRIL, HYDROCHLOROTHIAZIDE. Patient died on 12/18/2008.

Botulinum Side Effects Report: 6560229-3,Type Iv Hypersensitivity Reaction
on Jan 14, 2005 Female patient from UNITED STATES, , 46 years of age, was diagnosed with skin wrinkling and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: type iv hypersensitivity reaction. Botulinum dosage: 20units, Prn. During the same period patient was treated with INJECTABLE FILLER.


Botulinum Side Effects Report: 6542440-0,Foot Deformity
on Jan 12, 2010 Male patient from CANADA, , 63 years of age, was diagnosed with muscle spasticity, cerebrovascular accident and was treated with Botulinum. After Botulinum was administered, patient had the following side effects: foot deformity. Botulinum dosage: 200 Units, Single. During the same period patient was treated with BOTULINUM TOXIN TYPE A, ANDROGEL, LEVOTHYROXINE, LIPITOR, PREDNISONE, PANTOPRAZOLE, ENALAPRIL, AGGRENOX.

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