Drug information for BOTOX
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
VIAL; SINGLE-USE
100 UNITS/VIAL
Prescription
OnabotulinumtoxinA
onabotulinumtoxinA
ALLERGAN
103000
2011-08-30 Letter
2011-08-30 Label
2011-07-08 Label
2010-10-20 Letter
2010-10-19 Label
2010-04-01 Other
2010-03-18 Letter
2010-03-17 Label
2009-12-18 Other
2009-11-16 Medication Guide
2009-08-07 Letter
2009-08-07 Letter
2009-08-07 Label
2009-08-07 Label
2008-08-12 Other Important Information from FDA
2004-09-15 Label
2004-07-21 Letter
2004-03-11 Review
2004-03-11 Letter
2004-03-11 Review
2004-03-11 Label
2004-03-11 Letter
VIAL; SINGLE-USE
200 UNITS/VIAL
Prescription
OnabotulinumtoxinA
onabotulinumtoxinA
ALLERGAN
"
VIAL; SINGLE-USE
50 UNITS/VIAL
Prescription
OnabotulinumtoxinA
Botulinum Toxins, Type A
ALLERGAN
"
Drug Adverse Effects information for BOTOX
Role code
Indications
Reaction
# Reports
PS
CARNITINE DEFICIENCY
CARDIO-RESPIRATORY ARREST
1
PS
CARNITINE DEFICIENCY
HYPERTONIA
1
PS
CARNITINE DEFICIENCY
OXYGEN SATURATION DECREASED
1
PS
CARNITINE DEFICIENCY
RESPIRATORY FAILURE
1
PS
CONSTIPATION
CARDIO-RESPIRATORY ARREST
2
PS
CONSTIPATION
HYPERTONIA
2
PS
CONSTIPATION
OXYGEN SATURATION DECREASED
2
PS
CONSTIPATION
RESPIRATORY FAILURE
2
PS
EPILEPSY
CARDIO-RESPIRATORY ARREST
2
PS
EPILEPSY
HYPERTONIA
2
PS
EPILEPSY
OXYGEN SATURATION DECREASED
2
PS
EPILEPSY
RESPIRATORY FAILURE
2
PS
FACIAL SPASM
ACCIDENTAL EXPOSURE
1
PS
FACIAL SPASM
LAGOPHTHALMOS
1
PS
FACIAL SPASM
PUNCTATE KERATITIS
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
CARDIO-RESPIRATORY ARREST
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
HYPERTONIA
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
OXYGEN SATURATION DECREASED
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
RESPIRATORY FAILURE
1
PS
HYPERLIPIDAEMIA
ALANINE AMINOTRANSFERASE ABNORMAL
2
PS
HYPERLIPIDAEMIA
ARRHYTHMIA SUPRAVENTRICULAR
1
PS
HYPERLIPIDAEMIA
ASPARTATE AMINOTRANSFERASE ABNORMAL
2
PS
HYPERLIPIDAEMIA
BLOOD ALKALINE PHOSPHATASE ABNORMAL
2
PS
HYPERLIPIDAEMIA
BLOOD BILIRUBIN ABNORMAL
2
PS
HYPERLIPIDAEMIA
BLOOD LACTATE DEHYDROGENASE ABNORMAL
2
PS
HYPERLIPIDAEMIA
DIZZINESS
1
PS
HYPERLIPIDAEMIA
DYSSTASIA
1
PS
HYPERLIPIDAEMIA
ELECTROCARDIOGRAM P WAVE ABNORMAL
1
PS
HYPERLIPIDAEMIA
GAMMA-GLUTAMYLTRANSFERASE ABNORMAL
2
PS
HYPERLIPIDAEMIA
HEPATIC ENZYME INCREASED
1
PS
HYPERLIPIDAEMIA
HEPATIC FUNCTION ABNORMAL
1
PS
HYPERLIPIDAEMIA
HEPATOMEGALY
2
PS
HYPERLIPIDAEMIA
INFLAMMATION
1
PS
HYPERLIPIDAEMIA
MALAISE
2
PS
HYPERLIPIDAEMIA
NAUSEA
2
PS
HYPERLIPIDAEMIA
PALPITATIONS
2
PS
HYPERLIPIDAEMIA
PYELONEPHRITIS
1
PS
HYPERLIPIDAEMIA
RENAL IMPAIRMENT
1
PS
HYPERLIPIDAEMIA
TACHYARRHYTHMIA
2
PS
HYPERLIPIDAEMIA
VOMITING
1
PS
HYPERLIPIDAEMIA
WHITE BLOOD CELL COUNT ABNORMAL
2
PS
HYPERSENSITIVITY
ABNORMAL BEHAVIOUR
1
PS
HYPERSENSITIVITY
ARTHRALGIA
1
PS
HYPERSENSITIVITY
ASTHENIA
1
PS
HYPERSENSITIVITY
DIPLOPIA
1
PS
HYPERSENSITIVITY
GAIT DISTURBANCE
1
PS
HYPERSENSITIVITY
IRRITABILITY
1
PS
HYPERSENSITIVITY
MUSCULOSKELETAL PAIN
1
PS
HYPERSENSITIVITY
PAIN IN EXTREMITY
1
PS
HYPERSENSITIVITY
PHOTOPHOBIA
1
PS
HYPERSENSITIVITY
SINUSITIS
1
PS
HYPERSENSITIVITY
UPPER RESPIRATORY TRACT INFECTION
1
PS
HYPERSENSITIVITY
VISION BLURRED
1
PS
HYPERTENSION
ALANINE AMINOTRANSFERASE ABNORMAL
2
PS
HYPERTENSION
ARRHYTHMIA SUPRAVENTRICULAR
1
PS
HYPERTENSION
ASPARTATE AMINOTRANSFERASE ABNORMAL
2
PS
HYPERTENSION
BLOOD ALKALINE PHOSPHATASE ABNORMAL
2
PS
HYPERTENSION
BLOOD BILIRUBIN ABNORMAL
2
PS
HYPERTENSION
BLOOD LACTATE DEHYDROGENASE ABNORMAL
2
PS
HYPERTENSION
DIZZINESS
1
PS
HYPERTENSION
DYSSTASIA
1
PS
HYPERTENSION
ELECTROCARDIOGRAM P WAVE ABNORMAL
1
PS
HYPERTENSION
GAMMA-GLUTAMYLTRANSFERASE ABNORMAL
2
PS
HYPERTENSION
HEPATIC ENZYME INCREASED
1
PS
HYPERTENSION
HEPATIC FUNCTION ABNORMAL
1
PS
HYPERTENSION
HEPATOMEGALY
2
PS
HYPERTENSION
INFLAMMATION
1
PS
HYPERTENSION
MALAISE
2
PS
HYPERTENSION
NAUSEA
2
PS
HYPERTENSION
PALPITATIONS
2
PS
HYPERTENSION
PYELONEPHRITIS
1
PS
HYPERTENSION
RENAL IMPAIRMENT
1
PS
HYPERTENSION
TACHYARRHYTHMIA
2
PS
HYPERTENSION
VOMITING
1
PS
HYPERTENSION
WHITE BLOOD CELL COUNT ABNORMAL
2
PS
MIGRAINE
ANXIETY
1
PS
MIGRAINE
CONFUSIONAL STATE
1
PS
MIGRAINE
COUGH
1
PS
MIGRAINE
EAR PAIN
1
PS
MIGRAINE
FATIGUE
1
PS
MIGRAINE
FIBROMYALGIA
1
PS
MIGRAINE
HEADACHE
1
PS
MIGRAINE
HYPOAESTHESIA
1
PS
MIGRAINE
INFLUENZA LIKE ILLNESS
2
PS
MIGRAINE
MUSCLE SPASMS
1
PS
MIGRAINE
NAUSEA
1
PS
MIGRAINE
NECK PAIN
1
PS
MIGRAINE
PAIN
1
PS
MIGRAINE
THERAPEUTIC RESPONSE DECREASED
1
PS
MIGRAINE
VISUAL IMPAIRMENT
1
PS
MUSCLE SPASMS
ALANINE AMINOTRANSFERASE ABNORMAL
2
PS
MUSCLE SPASMS
ARRHYTHMIA SUPRAVENTRICULAR
1
PS
MUSCLE SPASMS
ASPARTATE AMINOTRANSFERASE ABNORMAL
2
PS
MUSCLE SPASMS
BLOOD ALKALINE PHOSPHATASE ABNORMAL
2
PS
MUSCLE SPASMS
BLOOD BILIRUBIN ABNORMAL
2
PS
MUSCLE SPASMS
BLOOD LACTATE DEHYDROGENASE ABNORMAL
2
PS
MUSCLE SPASMS
DIZZINESS
1
PS
MUSCLE SPASMS
DYSSTASIA
1
PS
MUSCLE SPASMS
ELECTROCARDIOGRAM P WAVE ABNORMAL
1
PS
MUSCLE SPASMS
FALL
1
PS
MUSCLE SPASMS
GAMMA-GLUTAMYLTRANSFERASE ABNORMAL
2
PS
MUSCLE SPASMS
HEPATIC ENZYME INCREASED
1
PS
MUSCLE SPASMS
HEPATIC FUNCTION ABNORMAL
1
PS
MUSCLE SPASMS
HEPATOMEGALY
2
PS
MUSCLE SPASMS
INFLAMMATION
1
PS
MUSCLE SPASMS
JOINT DISLOCATION
2
PS
MUSCLE SPASMS
MALAISE
2
PS
MUSCLE SPASMS
NAUSEA
2
PS
MUSCLE SPASMS
NO ADVERSE EVENT
1
PS
MUSCLE SPASMS
PALPITATIONS
2
PS
MUSCLE SPASMS
PYELONEPHRITIS
1
PS
MUSCLE SPASMS
RADIUS FRACTURE
1
PS
MUSCLE SPASMS
RENAL IMPAIRMENT
1
PS
MUSCLE SPASMS
TACHYARRHYTHMIA
2
PS
MUSCLE SPASMS
VOMITING
1
PS
MUSCLE SPASMS
WHITE BLOOD CELL COUNT ABNORMAL
2
PS
MUSCLE TIGHTNESS
CARDIO-RESPIRATORY ARREST
5
PS
MUSCLE TIGHTNESS
HYPERTONIA
5
PS
MUSCLE TIGHTNESS
OXYGEN SATURATION DECREASED
5
PS
MUSCLE TIGHTNESS
RESPIRATORY FAILURE
5
PS
OCULAR DISCOMFORT
INJECTION SITE ERYTHEMA
1
PS
OCULAR DISCOMFORT
MIGRAINE
1
PS
OCULAR DISCOMFORT
SWELLING FACE
1
PS
SKIN COSMETIC PROCEDURE
DISTURBANCE IN ATTENTION
1
PS
SKIN COSMETIC PROCEDURE
DIZZINESS
1
PS
SKIN COSMETIC PROCEDURE
EYELID PTOSIS
1
PS
SKIN COSMETIC PROCEDURE
FACIAL PARESIS
1
PS
SKIN COSMETIC PROCEDURE
FATIGUE
1
PS
SKIN COSMETIC PROCEDURE
HEADACHE
2
PS
SKIN COSMETIC PROCEDURE
MUSCULAR WEAKNESS
1
PS
SKIN COSMETIC PROCEDURE
MUSCULOSKELETAL PAIN
1
PS
SKIN COSMETIC PROCEDURE
NECK PAIN
1
PS
SKIN COSMETIC PROCEDURE
PYREXIA
1
PS
SKIN COSMETIC PROCEDURE
SINUS DISORDER
1
PS
SKIN COSMETIC PROCEDURE
THINKING ABNORMAL
1
PS
SKIN COSMETIC PROCEDURE
VISION BLURRED
1
PS
SKIN WRINKLING
ANXIETY
1
PS
SKIN WRINKLING
ASTHENIA
1
PS
SKIN WRINKLING
DISORIENTATION
1
PS
SKIN WRINKLING
DIZZINESS
1
PS
SKIN WRINKLING
DRUG INEFFECTIVE
1
PS
SKIN WRINKLING
DRY MOUTH
1
PS
SKIN WRINKLING
DYSPHAGIA
1
PS
SKIN WRINKLING
DYSPNOEA
1
PS
SKIN WRINKLING
FEAR
1
PS
SKIN WRINKLING
FEELING HOT
1
PS
SKIN WRINKLING
HEART RATE INCREASED
1
PS
SKIN WRINKLING
HYPOAESTHESIA
1
PS
SKIN WRINKLING
MIDDLE INSOMNIA
1
PS
SKIN WRINKLING
PALPITATIONS
1
PS
SKIN WRINKLING
PARAESTHESIA
1
PS
SKIN WRINKLING
PARAESTHESIA ORAL
1
PS
SKIN WRINKLING
PHARYNGEAL HYPOAESTHESIA
1
PS
SKIN WRINKLING
TONGUE DRY
1
PS
SKIN WRINKLING
TREMOR
1
PS
TORTICOLLIS
ALOPECIA
1
PS
TORTICOLLIS
APNOEA
1
PS
TORTICOLLIS
CARDIAC FAILURE ACUTE
2
PS
TORTICOLLIS
DEATH
1
PS
TORTICOLLIS
RESPIRATORY ARREST
1
PS
TORTICOLLIS
SKIN BURNING SENSATION
1
PS
VIITH NERVE PARALYSIS
HYPOAESTHESIA ORAL
1
PS
VIITH NERVE PARALYSIS
HYPOTONIA
1
PS
VIITH NERVE PARALYSIS
MUSCULAR WEAKNESS
1
PS
VIITH NERVE PARALYSIS
OPHTHALMOPLEGIA
1
SS
ANORECTAL DISORDER
ANORECTAL DISORDER
1
SS
ANORECTAL DISORDER
ARTHRALGIA
1
SS
ANORECTAL DISORDER
BLADDER SPASM
1
SS
ANORECTAL DISORDER
CONSTIPATION
1
SS
ANORECTAL DISORDER
DISCOMFORT
1
SS
ANORECTAL DISORDER
DRUG INEFFECTIVE
1
SS
ANORECTAL DISORDER
DYSSTASIA
1
SS
ANORECTAL DISORDER
FAECES HARD
1
SS
ANORECTAL DISORDER
HAEMORRHOIDAL HAEMORRHAGE
1
SS
ANORECTAL DISORDER
INFLUENZA LIKE ILLNESS
1
SS
ANORECTAL DISORDER
INJECTION SITE PAIN
1
SS
ANORECTAL DISORDER
MIGRAINE
1
SS
ANORECTAL DISORDER
MUSCLE SPASMS
1
SS
ANORECTAL DISORDER
PAIN
1
SS
ANORECTAL DISORDER
PHOTOSENSITIVITY REACTION
1
SS
ANORECTAL DISORDER
VAGINISMUS
1
SS
ANXIETY
TORTICOLLIS
1
SS
BIPOLAR II DISORDER
ANORECTAL DISORDER
1
SS
BIPOLAR II DISORDER
ARTHRALGIA
1
SS
BIPOLAR II DISORDER
BLADDER SPASM
1
SS
BIPOLAR II DISORDER
CONSTIPATION
1
SS
BIPOLAR II DISORDER
DISCOMFORT
1
SS
BIPOLAR II DISORDER
DRUG INEFFECTIVE
1
SS
BIPOLAR II DISORDER
DYSSTASIA
1
SS
BIPOLAR II DISORDER
FAECES HARD
1
SS
BIPOLAR II DISORDER
HAEMORRHOIDAL HAEMORRHAGE
1
SS
BIPOLAR II DISORDER
INFLUENZA LIKE ILLNESS
1
SS
BIPOLAR II DISORDER
INJECTION SITE PAIN
1
SS
BIPOLAR II DISORDER
MIGRAINE
1
SS
BIPOLAR II DISORDER
MUSCLE SPASMS
1
SS
BIPOLAR II DISORDER
PAIN
1
SS
BIPOLAR II DISORDER
PHOTOSENSITIVITY REACTION
1
SS
BIPOLAR II DISORDER
VAGINISMUS
1
SS
CONSTIPATION
ANORECTAL DISORDER
1
SS
CONSTIPATION
ARTHRALGIA
1
SS
CONSTIPATION
BLADDER SPASM
1
SS
CONSTIPATION
CONSTIPATION
1
SS
CONSTIPATION
DISCOMFORT
1
SS
CONSTIPATION
DRUG INEFFECTIVE
1
SS
CONSTIPATION
DYSSTASIA
1
SS
CONSTIPATION
FAECES HARD
1
SS
CONSTIPATION
HAEMORRHOIDAL HAEMORRHAGE
1
SS
CONSTIPATION
INFLUENZA LIKE ILLNESS
1
SS
CONSTIPATION
INJECTION SITE PAIN
1
SS
CONSTIPATION
MIGRAINE
1
SS
CONSTIPATION
MUSCLE SPASMS
1
SS
CONSTIPATION
PAIN
1
SS
CONSTIPATION
PHOTOSENSITIVITY REACTION
1
SS
CONSTIPATION
VAGINISMUS
1
SS
DEPRESSION
TORTICOLLIS
1
SS
FAECES HARD
ANORECTAL DISORDER
1
SS
FAECES HARD
ARTHRALGIA
1
SS
FAECES HARD
BLADDER SPASM
1
SS
FAECES HARD
CONSTIPATION
1
SS
FAECES HARD
DISCOMFORT
1
SS
FAECES HARD
DRUG INEFFECTIVE
1
SS
FAECES HARD
DYSSTASIA
1
SS
FAECES HARD
FAECES HARD
1
SS
FAECES HARD
HAEMORRHOIDAL HAEMORRHAGE
1
SS
FAECES HARD
INFLUENZA LIKE ILLNESS
1
SS
FAECES HARD
INJECTION SITE PAIN
1
SS
FAECES HARD
MIGRAINE
1
SS
FAECES HARD
MUSCLE SPASMS
1
SS
FAECES HARD
PAIN
1
SS
FAECES HARD
PHOTOSENSITIVITY REACTION
1
SS
FAECES HARD
VAGINISMUS
1
SS
HAEMORRHOIDS
ANORECTAL DISORDER
1
SS
HAEMORRHOIDS
ARTHRALGIA
1
SS
HAEMORRHOIDS
BLADDER SPASM
1
SS
HAEMORRHOIDS
CONSTIPATION
1
SS
HAEMORRHOIDS
DISCOMFORT
1
SS
HAEMORRHOIDS
DRUG INEFFECTIVE
1
SS
HAEMORRHOIDS
DYSSTASIA
1
SS
HAEMORRHOIDS
FAECES HARD
1
SS
HAEMORRHOIDS
HAEMORRHOIDAL HAEMORRHAGE
1
SS
HAEMORRHOIDS
INFLUENZA LIKE ILLNESS
1
SS
HAEMORRHOIDS
INJECTION SITE PAIN
1
SS
HAEMORRHOIDS
MIGRAINE
1
SS
HAEMORRHOIDS
MUSCLE SPASMS
1
SS
HAEMORRHOIDS
PAIN
1
SS
HAEMORRHOIDS
PHOTOSENSITIVITY REACTION
1
SS
HAEMORRHOIDS
VAGINISMUS
1
SS
HYPERLIPIDAEMIA
ALANINE AMINOTRANSFERASE ABNORMAL
4
SS
HYPERLIPIDAEMIA
ARRHYTHMIA SUPRAVENTRICULAR
3
SS
HYPERLIPIDAEMIA
ASPARTATE AMINOTRANSFERASE ABNORMAL
4
SS
HYPERLIPIDAEMIA
BLOOD ALKALINE PHOSPHATASE ABNORMAL
4
SS
HYPERLIPIDAEMIA
BLOOD BILIRUBIN ABNORMAL
4
SS
HYPERLIPIDAEMIA
BLOOD LACTATE DEHYDROGENASE ABNORMAL
4
SS
HYPERLIPIDAEMIA
DIZZINESS
3
SS
HYPERLIPIDAEMIA
DYSSTASIA
3
SS
HYPERLIPIDAEMIA
ELECTROCARDIOGRAM P WAVE ABNORMAL
3
SS
HYPERLIPIDAEMIA
GAMMA-GLUTAMYLTRANSFERASE ABNORMAL
4
SS
HYPERLIPIDAEMIA
HEPATIC ENZYME INCREASED
3
SS
HYPERLIPIDAEMIA
HEPATIC FUNCTION ABNORMAL
3
SS
HYPERLIPIDAEMIA
HEPATOMEGALY
4
SS
HYPERLIPIDAEMIA
INFLAMMATION
3
SS
HYPERLIPIDAEMIA
MALAISE
4
SS
HYPERLIPIDAEMIA
NAUSEA
4
SS
HYPERLIPIDAEMIA
PALPITATIONS
4
SS
HYPERLIPIDAEMIA
PYELONEPHRITIS
3
SS
HYPERLIPIDAEMIA
RENAL IMPAIRMENT
3
SS
HYPERLIPIDAEMIA
TACHYARRHYTHMIA
4
SS
HYPERLIPIDAEMIA
VOMITING
3
SS
HYPERLIPIDAEMIA
WHITE BLOOD CELL COUNT ABNORMAL
4
SS
HYPERTENSION
ALANINE AMINOTRANSFERASE ABNORMAL
4
SS
HYPERTENSION
ANORECTAL DISORDER
1
SS
HYPERTENSION
ARRHYTHMIA SUPRAVENTRICULAR
3
SS
HYPERTENSION
ARTHRALGIA
1
SS
HYPERTENSION
ASPARTATE AMINOTRANSFERASE ABNORMAL
4
SS
HYPERTENSION
BLADDER SPASM
1
SS
HYPERTENSION
BLOOD ALKALINE PHOSPHATASE ABNORMAL
4
SS
HYPERTENSION
BLOOD BILIRUBIN ABNORMAL
4
SS
HYPERTENSION
BLOOD LACTATE DEHYDROGENASE ABNORMAL
4
SS
HYPERTENSION
CONSTIPATION
1
SS
HYPERTENSION
DISCOMFORT
1
SS
HYPERTENSION
DIZZINESS
3
SS
HYPERTENSION
DRUG INEFFECTIVE
1
SS
HYPERTENSION
DYSSTASIA
4
SS
HYPERTENSION
ELECTROCARDIOGRAM P WAVE ABNORMAL
3
SS
HYPERTENSION
FAECES HARD
1
SS
HYPERTENSION
GAMMA-GLUTAMYLTRANSFERASE ABNORMAL
4
SS
HYPERTENSION
HAEMORRHOIDAL HAEMORRHAGE
1
SS
HYPERTENSION
HEPATIC ENZYME INCREASED
3
SS
HYPERTENSION
HEPATIC FUNCTION ABNORMAL
3
SS
HYPERTENSION
HEPATOMEGALY
4
SS
HYPERTENSION
INFLAMMATION
3
SS
HYPERTENSION
INFLUENZA LIKE ILLNESS
1
SS
HYPERTENSION
INJECTION SITE PAIN
1
SS
HYPERTENSION
MALAISE
4
SS
HYPERTENSION
MIGRAINE
1
SS
HYPERTENSION
MUSCLE SPASMS
1
SS
HYPERTENSION
NAUSEA
4
SS
HYPERTENSION
PAIN
1
SS
HYPERTENSION
PALPITATIONS
4
SS
HYPERTENSION
PHOTOSENSITIVITY REACTION
1
SS
HYPERTENSION
PYELONEPHRITIS
3
SS
HYPERTENSION
RENAL IMPAIRMENT
3
SS
HYPERTENSION
TACHYARRHYTHMIA
4
SS
HYPERTENSION
VAGINISMUS
1
SS
HYPERTENSION
VOMITING
3
SS
HYPERTENSION
WHITE BLOOD CELL COUNT ABNORMAL
4
SS
MIGRAINE
ANORECTAL DISORDER
2
SS
MIGRAINE
ARTHRALGIA
2
SS
MIGRAINE
BLADDER SPASM
2
SS
MIGRAINE
CONSTIPATION
2
SS
MIGRAINE
DISCOMFORT
2
SS
MIGRAINE
DRUG INEFFECTIVE
2
SS
MIGRAINE
DYSSTASIA
2
SS
MIGRAINE
FAECES HARD
2
SS
MIGRAINE
HAEMORRHOIDAL HAEMORRHAGE
2
SS
MIGRAINE
INFLUENZA LIKE ILLNESS
2
SS
MIGRAINE
INJECTION SITE PAIN
2
SS
MIGRAINE
MIGRAINE
2
SS
MIGRAINE
MUSCLE SPASMS
2
SS
MIGRAINE
PAIN
2
SS
MIGRAINE
PHOTOSENSITIVITY REACTION
2
SS
MIGRAINE
VAGINISMUS
2
SS
MUSCLE SPASMS
ALANINE AMINOTRANSFERASE ABNORMAL
4
SS
MUSCLE SPASMS
ARRHYTHMIA SUPRAVENTRICULAR
3
SS
MUSCLE SPASMS
ASPARTATE AMINOTRANSFERASE ABNORMAL
4
SS
MUSCLE SPASMS
BLOOD ALKALINE PHOSPHATASE ABNORMAL
4
SS
MUSCLE SPASMS
BLOOD BILIRUBIN ABNORMAL
4
SS
MUSCLE SPASMS
BLOOD LACTATE DEHYDROGENASE ABNORMAL
4
SS
MUSCLE SPASMS
DIZZINESS
3
SS
MUSCLE SPASMS
DYSSTASIA
3
SS
MUSCLE SPASMS
ELECTROCARDIOGRAM P WAVE ABNORMAL
3
SS
MUSCLE SPASMS
GAMMA-GLUTAMYLTRANSFERASE ABNORMAL
4
SS
MUSCLE SPASMS
HEPATIC ENZYME INCREASED
3
SS
MUSCLE SPASMS
HEPATIC FUNCTION ABNORMAL
3
SS
MUSCLE SPASMS
HEPATOMEGALY
4
SS
MUSCLE SPASMS
INFLAMMATION
3
SS
MUSCLE SPASMS
JOINT DISLOCATION
2
SS
MUSCLE SPASMS
MALAISE
4
SS
MUSCLE SPASMS
NAUSEA
4
SS
MUSCLE SPASMS
PALPITATIONS
4
SS
MUSCLE SPASMS
PYELONEPHRITIS
3
SS
MUSCLE SPASMS
RENAL IMPAIRMENT
3
SS
MUSCLE SPASMS
TACHYARRHYTHMIA
4
SS
MUSCLE SPASMS
VOMITING
3
SS
MUSCLE SPASMS
WHITE BLOOD CELL COUNT ABNORMAL
4
SS
PAIN
ANORECTAL DISORDER
1
SS
PAIN
ARTHRALGIA
1
SS
PAIN
BLADDER SPASM
1
SS
PAIN
CONSTIPATION
1
SS
PAIN
DISCOMFORT
1
SS
PAIN
DRUG INEFFECTIVE
1
SS
PAIN
DYSSTASIA
1
SS
PAIN
FAECES HARD
1
SS
PAIN
HAEMORRHOIDAL HAEMORRHAGE
1
SS
PAIN
INFLUENZA LIKE ILLNESS
1
SS
PAIN
INJECTION SITE PAIN
1
SS
PAIN
MIGRAINE
1
SS
PAIN
MUSCLE SPASMS
1
SS
PAIN
PAIN
1
SS
PAIN
PHOTOSENSITIVITY REACTION
1
SS
PAIN
VAGINISMUS
1
C
ANAL FISTULA
ANORECTAL CELLULITIS
2
C
ANXIETY
ABDOMINAL DISCOMFORT
2
C
ANXIETY
ANXIETY
2
C
ANXIETY
GALLBLADDER NON-FUNCTIONING
2
C
ANXIETY
HEART RATE IRREGULAR
2
C
ANXIETY
INJURY
2
C
ANXIETY
MITRAL VALVE PROLAPSE
2
C
ANXIETY
MYOCARDIAL INFARCTION
2
C
ANXIETY
PAIN
2
C
ANXIETY
PALPITATIONS
2
C
ANXIETY
VAGINAL INFECTION
2
C
ARTHRALGIA
ASTHENIA
1
C
ARTHRALGIA
BAND SENSATION
1
C
ARTHRALGIA
DIARRHOEA
1
C
ARTHRALGIA
DIZZINESS
1
C
ARTHRALGIA
DYSSTASIA
1
C
ARTHRALGIA
MUSCLE SPASMS
1
C
ARTHRALGIA
TREMOR
1
C
ARTHRALGIA
URINARY TRACT INFECTION
1
C
ARTHRALGIA
VISION BLURRED
1
C
ASTHMA
ACTIVITIES OF DAILY LIVING IMPAIRED
2
C
ASTHMA
DEPRESSED MOOD
2
C
ASTHMA
DRUG DOSE OMISSION
1
C
ASTHMA
DRUG INEFFECTIVE
2
C
ASTHMA
FALL
2
C
ASTHMA
FATIGUE
2
C
ASTHMA
FEELING ABNORMAL
2
C
ASTHMA
FEELING DRUNK
2
C
ASTHMA
HYPERTENSION
1
C
ASTHMA
INCREASED UPPER AIRWAY SECRETION
1
C
ASTHMA
MUSCULAR WEAKNESS
2
C
ASTHMA
PAIN
2
C
ASTHMA
TREMOR
1
C
ASTHMA
VISION BLURRED
2
C
ATRIAL FIBRILLATION
ABDOMINAL DISTENSION
1
C
ATRIAL FIBRILLATION
ABDOMINAL PAIN
1
C
ATRIAL FIBRILLATION
ADRENAL ADENOMA
1
C
ATRIAL FIBRILLATION
ANGINA PECTORIS
1
C
ATRIAL FIBRILLATION
ANXIETY
1
C
ATRIAL FIBRILLATION
ASTHENIA
1
C
ATRIAL FIBRILLATION
ATRIAL FIBRILLATION
1
C
ATRIAL FIBRILLATION
BACK PAIN
1
C
ATRIAL FIBRILLATION
BENIGN PROSTATIC HYPERPLASIA
1
C
ATRIAL FIBRILLATION
BODY TINEA
1
C
ATRIAL FIBRILLATION
CARDIAC MURMUR
1
C
ATRIAL FIBRILLATION
CARPAL TUNNEL SYNDROME
1
C
ATRIAL FIBRILLATION
CHAPPED LIPS
1
C
ATRIAL FIBRILLATION
CHEILOSIS
1
C
ATRIAL FIBRILLATION
COLONIC POLYP
1
C
ATRIAL FIBRILLATION
CONSTIPATION
1
C
ATRIAL FIBRILLATION
CONTUSION
1
C
ATRIAL FIBRILLATION
CORONARY ARTERY DISEASE
1
C
ATRIAL FIBRILLATION
CYST
1
C
ATRIAL FIBRILLATION
DECREASED APPETITE
1
C
ATRIAL FIBRILLATION
DEPRESSION
1
C
ATRIAL FIBRILLATION
DIVERTICULUM
1
C
ATRIAL FIBRILLATION
DYSLIPIDAEMIA
1
C
ATRIAL FIBRILLATION
DYSURIA
1
C
ATRIAL FIBRILLATION
ECONOMIC PROBLEM
1
C
ATRIAL FIBRILLATION
EPISTAXIS
1
C
ATRIAL FIBRILLATION
FALL
1
C
ATRIAL FIBRILLATION
FLANK PAIN
1
C
ATRIAL FIBRILLATION
GASTRIC ULCER
1
C
ATRIAL FIBRILLATION
GASTRITIS
1
C
ATRIAL FIBRILLATION
GASTROOESOPHAGEAL REFLUX DISEASE
1
C
ATRIAL FIBRILLATION
HAEMATOMA
1
C
ATRIAL FIBRILLATION
HAEMATURIA
1
C
ATRIAL FIBRILLATION
HEPATIC CYST
1
C
ATRIAL FIBRILLATION
HEPATIC STEATOSIS
1
C
ATRIAL FIBRILLATION
HYPERTENSION
1
C
ATRIAL FIBRILLATION
HYPOAESTHESIA
1
C
ATRIAL FIBRILLATION
HYPOGONADISM
1
C
ATRIAL FIBRILLATION
ILIAC ARTERY STENOSIS
1
C
ATRIAL FIBRILLATION
IMPAIRED GASTRIC EMPTYING
1
C
ATRIAL FIBRILLATION
INFLAMMATION
1
C
ATRIAL FIBRILLATION
INTERVERTEBRAL DISC DEGENERATION
1
C
ATRIAL FIBRILLATION
MITRAL VALVE INCOMPETENCE
1
C
ATRIAL FIBRILLATION
MITRAL VALVE PROLAPSE
1
C
ATRIAL FIBRILLATION
MULTIPLE INJURIES
1
C
ATRIAL FIBRILLATION
MUSCLE SPASMS
1
C
ATRIAL FIBRILLATION
MUSCULAR WEAKNESS
1
C
ATRIAL FIBRILLATION
OESOPHAGEAL ACHALASIA
1
C
ATRIAL FIBRILLATION
OESOPHAGITIS
1
C
ATRIAL FIBRILLATION
OSTEOARTHRITIS
1
C
ATRIAL FIBRILLATION
OSTEOPOROSIS
1
C
ATRIAL FIBRILLATION
PAIN
1
C
ATRIAL FIBRILLATION
RENAL CYST
1
C
ATRIAL FIBRILLATION
RHINITIS ALLERGIC
1
C
ATRIAL FIBRILLATION
SCOLIOSIS
1
C
ATRIAL FIBRILLATION
SINUS ARRHYTHMIA
1
C
ATRIAL FIBRILLATION
SINUS BRADYCARDIA
1
C
ATRIAL FIBRILLATION
SLEEP APNOEA SYNDROME
1
C
ATRIAL FIBRILLATION
SPLENIC CYST
1
C
ATRIAL FIBRILLATION
STRESS
1
C
ATRIAL FIBRILLATION
TRICUSPID VALVE INCOMPETENCE
1
C
ATRIAL FIBRILLATION
VENTRICULAR EXTRASYSTOLES
1
C
ATRIAL FIBRILLATION
WEIGHT INCREASED
1
C
BACK PAIN
DEATH
1
C
BACK PAIN
PERIRECTAL ABSCESS
1
C
BLADDER DISORDER
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
1
C
BLADDER DISORDER
RENAL FAILURE
1
C
BLADDER DISORDER
UROSEPSIS
1
C
BLEPHAROSPASM
DRUG DOSE OMISSION
1
C
BLEPHAROSPASM
HYPERTENSION
1
C
BLEPHAROSPASM
INCREASED UPPER AIRWAY SECRETION
1
C
BLEPHAROSPASM
TREMOR
1
C
CONSTIPATION
ANORECTAL CELLULITIS
1
C
CONSTIPATION
DEATH
1
C
CONSTIPATION
PERIRECTAL ABSCESS
1
C
CONVULSION
DIARRHOEA
2
C
CONVULSION
PYREXIA
2
C
CONVULSION
URINARY TRACT INFECTION
2
C
CONVULSION
VIRAL INFECTION
2
C
CONVULSION
VOMITING
2
C
DEMENTIA
DEATH
3
C
DEMENTIA
PERIRECTAL ABSCESS
3
C
DEPRESSION
HEADACHE
1
C
DEPRESSION
INSOMNIA
1
C
DEPRESSION
NAUSEA
1
C
DYSTONIA
DYSTONIA
1
C
DYSTONIA
MUSCLE SPASMS
1
C
DYSTONIA
PARKINSON'S DISEASE
1
C
EAR PAIN
ACCIDENTAL OVERDOSE
4
C
EAR PAIN
ACUTE HEPATIC FAILURE
4
C
EAR PAIN
HEPATIC ENCEPHALOPATHY
4
C
EAR PAIN
RENAL FAILURE ACUTE
4
C
EAR PAIN
RHABDOMYOLYSIS
4
C
FIBROMYALGIA
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
FIBROMYALGIA
DEPRESSED MOOD
1
C
FIBROMYALGIA
DRUG INEFFECTIVE
1
C
FIBROMYALGIA
FALL
1
C
FIBROMYALGIA
FATIGUE
1
C
FIBROMYALGIA
FEELING ABNORMAL
1
C
FIBROMYALGIA
FEELING DRUNK
1
C
FIBROMYALGIA
MUSCULAR WEAKNESS
1
C
FIBROMYALGIA
PAIN
1
C
FIBROMYALGIA
VISION BLURRED
1
C
HEADACHE
ACCIDENTAL OVERDOSE
6
C
HEADACHE
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
HEADACHE
ACUTE HEPATIC FAILURE
6
C
HEADACHE
DEPRESSED MOOD
1
C
HEADACHE
DRUG INEFFECTIVE
1
C
HEADACHE
FALL
1
C
HEADACHE
FATIGUE
1
C
HEADACHE
FEELING ABNORMAL
1
C
HEADACHE
FEELING DRUNK
1
C
HEADACHE
HEPATIC ENCEPHALOPATHY
6
C
HEADACHE
MUSCULAR WEAKNESS
1
C
HEADACHE
PAIN
1
C
HEADACHE
RENAL FAILURE ACUTE
6
C
HEADACHE
RHABDOMYOLYSIS
6
C
HEADACHE
VISION BLURRED
1
C
HYPERCHOLESTEROLAEMIA
DEATH
1
C
HYPERCHOLESTEROLAEMIA
PERIRECTAL ABSCESS
1
C
HYPERTONIA
DIARRHOEA
1
C
HYPERTONIA
PYREXIA
1
C
HYPERTONIA
URINARY TRACT INFECTION
1
C
HYPERTONIA
VIRAL INFECTION
1
C
HYPERTONIA
VOMITING
1
C
INFECTION
ANORECTAL CELLULITIS
1
C
INFECTION
DEATH
1
C
INFECTION
PERIRECTAL ABSCESS
1
C
INSOMNIA
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
INSOMNIA
DEPRESSED MOOD
1
C
INSOMNIA
DRUG INEFFECTIVE
1
C
INSOMNIA
FALL
1
C
INSOMNIA
FATIGUE
1
C
INSOMNIA
FEELING ABNORMAL
1
C
INSOMNIA
FEELING DRUNK
1
C
INSOMNIA
MUSCULAR WEAKNESS
1
C
INSOMNIA
PAIN
1
C
INSOMNIA
VISION BLURRED
1
C
MIGRAINE
ABDOMINAL DISCOMFORT
2
C
MIGRAINE
ANXIETY
2
C
MIGRAINE
GALLBLADDER NON-FUNCTIONING
2
C
MIGRAINE
HEADACHE
1
C
MIGRAINE
HEART RATE IRREGULAR
2
C
MIGRAINE
INJURY
2
C
MIGRAINE
MITRAL VALVE PROLAPSE
2
C
MIGRAINE
MYOCARDIAL INFARCTION
2
C
MIGRAINE
PAIN
2
C
MIGRAINE
PALPITATIONS
3
C
MIGRAINE
SYNCOPE
1
C
MIGRAINE
VAGINAL INFECTION
2
C
MULTIPLE SCLEROSIS
ASTHENIA
2
C
MULTIPLE SCLEROSIS
BAND SENSATION
2
C
MULTIPLE SCLEROSIS
DIARRHOEA
2
C
MULTIPLE SCLEROSIS
DIZZINESS
2
C
MULTIPLE SCLEROSIS
DYSSTASIA
2
C
MULTIPLE SCLEROSIS
MENTAL STATUS CHANGES
1
C
MULTIPLE SCLEROSIS
MUSCLE SPASMS
2
C
MULTIPLE SCLEROSIS
NERVOUSNESS
1
C
MULTIPLE SCLEROSIS
PNEUMONIA
1
C
MULTIPLE SCLEROSIS
RESPIRATORY FAILURE
1
C
MULTIPLE SCLEROSIS
TREMOR
2
C
MULTIPLE SCLEROSIS
URINARY TRACT INFECTION
3
C
MULTIPLE SCLEROSIS
VISION BLURRED
2
C
MUSCLE DISORDER
DIARRHOEA
1
C
MUSCLE DISORDER
PYREXIA
1
C
MUSCLE DISORDER
URINARY TRACT INFECTION
1
C
MUSCLE DISORDER
VIRAL INFECTION
1
C
MUSCLE DISORDER
VOMITING
1
C
MUSCLE SPASMS
ASTHENIA
1
C
MUSCLE SPASMS
BAND SENSATION
1
C
MUSCLE SPASMS
DIARRHOEA
1
C
MUSCLE SPASMS
DIZZINESS
1
C
MUSCLE SPASMS
DYSSTASIA
1
C
MUSCLE SPASMS
MUSCLE SPASMS
1
C
MUSCLE SPASMS
TREMOR
1
C
MUSCLE SPASMS
URINARY TRACT INFECTION
1
C
MUSCLE SPASMS
VISION BLURRED
1
C
MUSCULOSKELETAL STIFFNESS
NERVOUSNESS
2
C
NASOPHARYNGITIS
NERVOUSNESS
2
C
NOCTURIA
DEATH
1
C
NOCTURIA
PERIRECTAL ABSCESS
1
C
ORTHOSTATIC HYPOTENSION
DEATH
1
C
ORTHOSTATIC HYPOTENSION
PERIRECTAL ABSCESS
1
C
OSTEOPOROSIS
DYSTONIA
1
C
OSTEOPOROSIS
FAECALITH
1
C
OSTEOPOROSIS
INTESTINAL ATRESIA
1
C
OSTEOPOROSIS
MUSCLE SPASMS
1
C
OSTEOPOROSIS
PARKINSON'S DISEASE
1
C
PARKINSON'S DISEASE
DEATH
4
C
PARKINSON'S DISEASE
PERIRECTAL ABSCESS
4
C
PRECOCIOUS PUBERTY
DIARRHOEA
1
C
PRECOCIOUS PUBERTY
PYREXIA
1
C
PRECOCIOUS PUBERTY
URINARY TRACT INFECTION
1
C
PRECOCIOUS PUBERTY
VIRAL INFECTION
1
C
PRECOCIOUS PUBERTY
VOMITING
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ACCIDENTAL OVERDOSE
4
C
PRODUCT USED FOR UNKNOWN INDICATION
ACUTE HEPATIC FAILURE
4
C
PRODUCT USED FOR UNKNOWN INDICATION
ANXIETY
3
C
PRODUCT USED FOR UNKNOWN INDICATION
APPETITE DISORDER
3
C
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD PRESSURE INCREASED
1
C
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD URIC ACID ABNORMAL
3
C
PRODUCT USED FOR UNKNOWN INDICATION
COUGH
3
C
PRODUCT USED FOR UNKNOWN INDICATION
DEPRESSION
3
C
PRODUCT USED FOR UNKNOWN INDICATION
DIARRHOEA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSCHEZIA
3
C
PRODUCT USED FOR UNKNOWN INDICATION
GASTRIC DISORDER
3
C
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
HEPATIC ENCEPHALOPATHY
4
C
PRODUCT USED FOR UNKNOWN INDICATION
HYPERHIDROSIS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
OBSESSIVE-COMPULSIVE DISORDER
3
C
PRODUCT USED FOR UNKNOWN INDICATION
PALPITATIONS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
PYREXIA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE ACUTE
4
C
PRODUCT USED FOR UNKNOWN INDICATION
RESPIRATORY TRACT IRRITATION
3
C
PRODUCT USED FOR UNKNOWN INDICATION
RHABDOMYOLYSIS
4
C
PRODUCT USED FOR UNKNOWN INDICATION
SKIN DISORDER
3
C
PRODUCT USED FOR UNKNOWN INDICATION
SYNCOPE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
URINARY TRACT INFECTION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
VIRAL INFECTION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
VOMITING
1
C
PROGRESSIVE RELAPSING MULTIPLE SCLEROSIS
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
1
C
PROGRESSIVE RELAPSING MULTIPLE SCLEROSIS
RENAL FAILURE
1
C
PROGRESSIVE RELAPSING MULTIPLE SCLEROSIS
UROSEPSIS
1
C
PROPHYLAXIS
DEATH
1
C
PROPHYLAXIS
PERIRECTAL ABSCESS
1
C
PROSTATE CANCER
DEATH
1
C
PROSTATE CANCER
PERIRECTAL ABSCESS
1
C
PSORIATIC ARTHROPATHY
DEATH
1
C
PSORIATIC ARTHROPATHY
PERIRECTAL ABSCESS
1
C
RESPIRATORY TRACT CONGESTION
DIARRHOEA
1
C
RESPIRATORY TRACT CONGESTION
PYREXIA
1
C
RESPIRATORY TRACT CONGESTION
URINARY TRACT INFECTION
1
C
RESPIRATORY TRACT CONGESTION
VIRAL INFECTION
1
C
RESPIRATORY TRACT CONGESTION
VOMITING
1
C
RHEUMATOID ARTHRITIS
GALLBLADDER DISORDER
1
C
SKIN LESION
ACCIDENTAL OVERDOSE
2
C
SKIN LESION
ACUTE HEPATIC FAILURE
2
C
SKIN LESION
HEPATIC ENCEPHALOPATHY
2
C
SKIN LESION
RENAL FAILURE ACUTE
2
C
SKIN LESION
RHABDOMYOLYSIS
2
C
SLEEP DISORDER
ABDOMINAL DISCOMFORT
2
C
SLEEP DISORDER
ANXIETY
2
C
SLEEP DISORDER
GALLBLADDER NON-FUNCTIONING
2
C
SLEEP DISORDER
HEART RATE IRREGULAR
2
C
SLEEP DISORDER
INJURY
2
C
SLEEP DISORDER
MITRAL VALVE PROLAPSE
2
C
SLEEP DISORDER
MYOCARDIAL INFARCTION
2
C
SLEEP DISORDER
PAIN
2
C
SLEEP DISORDER
PALPITATIONS
2
C
SLEEP DISORDER
VAGINAL INFECTION
2
C
WOUND INFECTION
DEATH
1
C
WOUND INFECTION
PERIRECTAL ABSCESS
1
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