OnabotulinumtoxinA (Botox)
بوتاکس (اونابوتولینومتوکسین A)
🦴 Musculo-Skeletal SystemBotulinum neurotoxin
Market / country: 🇺🇸 USA
Botox (US)
🧮 Dose calculator
Migraine prophylaxis · Regimen source: FDA Botox · 2.5
- • Botox units are not interchangeable with other botulinum products. In any 3 months: adults max 400 Units; children the lesser of 10 Units/kg or 340 Units. FDA Botox · 2.1FDA Botox · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to any botulinum toxin product; infection at the injection site; intradetrusor injection with UTI or urinary retention (PVR >200 mL) without clean intermittent catheterisation. FDA Botox · 4
Warnings
- • Boxed warning: distant spread of toxin effect (generalised weakness, diplopia, ptosis, swallowing and breathing difficulty — can be fatal), hours to weeks later; highest risk in children treated for spasticity. FDA Botox · Boxed Warning
- • Dysphagia and breathing difficulties; UTI and urinary retention after bladder injection; corneal ulceration in blepharospasm; autonomic dysreflexia. FDA Botox · 5
Formulations
- 100 Units vial — powder for injection 🇺🇸 USA FDA Botox · 3
- 200 Units vial — powder for injection 🇺🇸 USA FDA Botox · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Botox · 8.1
“Risk Summary There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Botox · 8.2
“Risk Summary There are no data on the presence of BOTOX in human or animal milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
Label: established for some indications (spasticity, neurogenic bladder from 5 y); toxin-spread risk is greatest in children treated for spasticity. FDA Botox · 8.4
“The safety and effectiveness of BOTOX for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years of age and older.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Botox · 8.5
“No overall differences in safety were observed between elderly patients and adult patients younger than 65 years of age.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA103000
- DailyMed (FDA label)FDA Botox
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDM03AX01
- Darooyab (Iran)Botulinum-Toxins
🇮🇷 Registered in Iran Darooyab · G-2786/Botulinum-Toxins
Dosage forms with Iranian generic codes, per Darooyab.
- 17768 · BOTULINIUM A TOXIN 100IU VIAL · ویال بوتولینوم A توکسین ۱۰۰ واحد بینالمللی
- 21097 · BOTULINIUM A TOXIN 50IU VIAL · ویال بوتولینوم A توکسین ۵۰ واحد بینالمللی
- 11798 · BOTULISM A TOXIN 1 VIAL · ویال بوتولیسم A توکسین ۱
- 19172 · BOTULISM A TOXIN 300IU VIAL · ویال بوتولیسم A توکسین ۳۰۰ واحد بینالمللی
- 03623 · BOTULISM A TOXIN 500IU VIAL · ویال بوتولیسم A توکسین ۵۰۰ واحد بینالمللی
- 24400 · BOTULINUM A TOXIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 200 [iU] · محلول تزریقی بوتولینوم A توکسین ۲۰۰ واحد بینالمللی
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Botox · 3FDA Botox · 2.5FDA Botox · 2.1FDA Botox · 2FDA Botox · 2.3FDA Botox · 2.9FDA Botox · 2.7FDA Botox · 2.6FDA Botox · 4FDA Botox · Boxed WarningFDA Botox · 5FDA Botox · 8.1FDA Botox · 8.2FDA Botox · 8.4FDA Botox · 8.5FDA Botox · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2786/Botulinum-Toxins
- Clinical review⚠ Unverified