Botulinum Toxin Type A

Table of contents

  • Brand Names
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Toxicological Effects
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Austria: Botox, Dysport; Belgium: Botox, Dysport, Vistabel; Czech Republic: Botox, Dysport; Denmark: Botox, Dysport; Finland: Botox, Dysport; France: Botox, Dysport, Vistabel; Germany: Botox, Dysport; Greece: Botox, Dysport; Hungary: Botox; Ireland: Botox, Dysport; Italy: Botox, Dysport; Latvia: Dysport, Vistabel; Lithuania: Dysport; Luxembourg: Botox; Netherlands: Botox, Dysport; Poland: Botox, Dysport; Portugal: Botox, Dysport; Slovakia: Botox, Dysport; Slovenia: Vistabel; Spain: Botox, Dysport, Vistabel, Xeomin; Sweden: Botox, Dysport; UK: Botox, Dysport.

North America

Canada: Botox; USA: Botox, Xeomin.

Latin America

Argentina: Botox, Dysport, Xeomin; Brazil: Botox, Dysport, Prosigne; Mexico: Botox, Dysport.


Japan: Botox.

Drug combinations


Pharmacologic Category

Skeletal Muscle Relaxants, Miscellaneous; Other Miscellaneous Therapeutic Agents. (ATC-Code: M03AX01).

Mechanism of action

Neurotoxin produced by Clostridium botulinum. Botulinum toxin disrupts neurotransmission by inhibiting release of acetylcholine at cholinergic nerve terminals of the peripheral nervous system and at ganglionic nerve terminals of the autonomic nervous system. Affects only the presynaptic membrane of the neuromuscular junction in humans, where it prevents calcium-dependent release of acetylcholine and produces a dose-dependent state of denervation and flaccid paralysis. Induces neuromuscular blockade via a zinc-dependent endopeptidase, which blocks vesicles containing acetylcholine from fusing with the terminal membrane of the motor neuron. When administered to extraocular muscles, following several weeks of paralysis, alignment of the eye is measurably changed, despite return of innervation to the injected muscle. Intradermal injection results in temporary sweat gland denervation, reducing local sweating.

Therapeutic use

Strabismus and blepharospasm associated with dystonia (including benign essential blepharospasm or VII nerve disorders) in patients ≥12 years of age. Cervical dystonia (spasmodic torticollis) in patients ≥16 years of age. Temporary improvement in the appearance of lines/wrinkles of the face (moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity) in adult patients ≤65 years of age. Severe primary axillary hyperhidrosis in adults not adequately controlled with topical treatments. Focal spasticity, including treatment of stroke related upper limb spasticity. Dynamic equines foot deformity in pediatric cerebral palsy patients. Dynamic muscle contracture in pediatric cerebral palsy patients. Sialorrhea, palmar hyperhidrosis, esophageal achalasia, chronic anal fissure, migraine headache.

Pregnancy and lactiation implications

Decreased fetal body weight, delayed ossification, maternal toxicity, abortions, and fetal malformations observed in animal studies. Human reproduction studies not conducted. Avoid use in pregnancy. Use with caution if administered during lactation.

Unlabeled use

Treatment of oromandibular dystonia, spasmodic dysphonia (laryngeal dystonia) and other dystonias (i.e. writer’s cramp, focal task-specific dystonias). Migraine treatment and prophylaxis. Treatment of dynamic muscle contracture in pediatric cerebral palsy patients.


Hypersensitivity to albumin, botulinum toxin, or any component of the formulation. Infection at the proposed injection site(s). Myasthenia gravis or Eaton-Lambert syndrome.

Warnings and precautions

Hypersensitivity and anaphylactic reactions may occur rarely. Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy. Rarely, arrhythmia and myocardial infarction reported, sometimes in pre-existing cardiovascular disease. Weakness of adjacent muscles commonly reported. Dysphagia is common when used for cervical dystonia (risk factors: smaller neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae). Excessive weakness of target muscles may also occur. Caution if there is excessive weakness or atrophy at the proposed injection site(s). Use is contraindicated if infection is present. Caution in patients with neuromuscular diseases and neuropathic disorders (such as amyotrophic lateral sclerosis), or those who are receiving other agents that may interfere with neuromuscular transmission (e.g. aminoglycosides, neuromuscular-blocking agents). Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration when treating blepharospasm. Retrobulbar hemorrhages may occur from needle penetration into orbit when treating strabismus; spatial disorientation, double vision, or past pointing may occur if one or more extraocular muscles are paralyzed. Careful testing of corneal sensation, avoidance of lower lid injections (to avoid ectropion), and treatment of epithelial defects are necessary. Use caution in angle closure glaucoma. Product contains albumin and may carry a remote risk of virus transmission (theoretical Creutzfeldt-Jakob disease via albumin component; no cases identified to date). Prior to treatment, a primary axillary hyperhidrosis evaluation for secondary causes (e.g. hyperthyroidism) should be made. When used for temporary reduction in glabellar lines, it should not be administered more frequently than every 3 months. Serious adverse events (including fatalities) in association with the use of botulinum types A and type B reported. The most serious outcomes, including respiratory failure and death, were associated with use in children for cerebral palsy limb spasticity. Should be administered with caution to patients with thrombocytopenia or bleeding disorder (e.g. hemophilia) or those receiving anticoagulant therapy. Patients who develop tolerance to botulinum toxin type A may respond to botulinum toxin type B or other botulinum toxin serotypes (e.g. botulinum toxin type F). Long-term effects of chronic therapy unknown.



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