Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Onabotulinumtoxina
Drug ID BADD_D01616
Description In 2002, botulinum toxin A, also known as onabotulinumtoxinA or Botox, was the first type A botulism toxin to be introduced into the market for cosmetic use.[A231824] With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic imperfections, muscle spasms, and other conditions.[A231819,L32569] A popular use for Botox is the treatment of facial wrinkles and lines, however, there are many uses for the botulinum toxin A in the treatment of dystonia, incontinence, migraine, blepharospasm, and hyperhidrosis.[L32494,L32559]
Indications and Usage Botulinum toxin A is indicated for a variety of conditions, depending on the preparations. Cosmetically, it is used for the treatment of facial fine lines and wrinkles, specifically for upper facial rhytides, including forehead, lateral canthus, and glabellar lines.[L32559] In addition to the above indications, botulinum toxin A is used for the following conditions: treatment of adults with symptomatic overactive bladder with or without incontinence, treatment of incontinence in adult patients who are not candidates for anticholinergic therapy, treatment of Neurogenic Detrusor Overactivity (NDO) in patients over 5 years who cannot undergo anticholinergic therapy. Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus,[L32494] and disorders of the 7th cranial nerve.[L32569] Off-label, botulinum toxin A is used for a variety of conditions such as temporomandibular joint (TMJ) disorders and myofascial pain[A231874], neurogenic thoracic outlet syndrome, epicondylitis, post-stroke pain, post-herpetic neuralgia, diabetic neuropathy, trigeminal neuralgia, neuropathic pain, spinal cord injury, and bladder pain.[A231879]
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB00083
KEGG ID D08957; D00783
MeSH ID D019274
PubChem ID Not Available
TTD Drug ID D0D1RM
NDC Product Code 0023-3921; 0023-1145; 0023-3919; 0023-9232
UNII Not Available
Synonyms Botulinum Toxins, Type A | Clostridium botulinum A Toxin | Botulinum Toxin A | Toxin A, Botulinum | Botulinum Neurotoxin A | Neurotoxin A, Botulinum | Botulinum A Toxin | Toxin, Botulinum A | Botulinum Toxin Type A | Botulinum Neurotoxin Type A | Clostridium Botulinum Toxin Type A | Meditoxin | Botox | Neuronox | Oculinum | Vistabex | OnabotulinumtoxinA | Onabotulinumtoxin A | Vistabel
Chemical Information
Molecular Formula Not Available
CAS Registry Number 93384-43-1
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Anxiety19.06.02.002--
Arrhythmia02.03.02.001---
Asthenia08.01.01.001---
Back pain15.03.04.005--
Bacteriuria11.02.01.014; 20.08.02.015---
Bronchitis11.01.09.001; 22.07.01.001--
Constipation07.02.02.001--
Corneal perforation06.06.03.006; 12.01.04.003---
Cough22.02.03.001--
Death08.04.01.001--
Diarrhoea07.02.01.001--
Diplopia06.02.06.002; 17.17.01.005---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dysarthria17.02.08.001; 19.19.03.001--
Dysphagia07.01.06.003--
Dysphonia17.02.08.004; 19.19.03.002; 22.12.03.006--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Ectropion06.06.04.001; 23.07.05.001---
Erythema multiforme10.01.03.015; 23.03.01.003--
Eye infection06.04.05.007; 11.01.06.001--
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003---
Eyelid ptosis06.05.01.002; 17.17.02.004---
Facial paralysis17.04.03.008---
Fall12.01.08.002--
Fatigue08.01.01.002--
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