Onabotulinumtoxina: uses, dosing, side effects & brands
Onabotulinumtoxina is a medicine sold in the U.S. under 2 brand and generic names, for blepharospasm, dystonia and fissure in ano. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Blepharospasm, Dystonia and Fissure in Ano
- Available as
- Injectable
- Sold as
- 2 products — Botox and Botox Cosmetic
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How onabotulinumtoxina is dosed
From the FDA label for Botox (application BLA103000). Other onabotulinumtoxina products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Follow indication-specific dosage and administration recommendations. In a 3 month interval, do not exceed a total dose of: • Adults: 400 Units • Pediatrics: the lesser of 10 Units/kg or 340 Units ( 2.1 ) See Preparation and Dilution Technique for instructions on BOTOX reconstitution, storage, and preparation before injection ( 2.2 ) Overactive Bladder: Recommended total dose 100 Units, as 0.5 mL (5 Units) injections across 20 sites into the detrusor ( 2.3 ) Adult Detrusor Overactivity associated with a Neurologic Condition: Recommended total dose 200 Units, as 1 mL (~6.7 Units) injections across 30 sites into the detrusor ( 2.3 ) Pediatric Detrusor Overactivity associated with a Neurologic Condition: 0.5 mL injections across 20 sites into the detrusor ( 2.4 ) • Greater than or equal to 34 kg: Recommended total dose is 200 Units • Less than 34 kg: Recommended total dose is 6 Units/kg Chronic Migraine: Recommended total dose 155 Units, as 0.1 mL (5 Units) injections per each site divided across 7 head/neck muscles ( 2.5 ) Adult Upper Limb Spasticity: Recommended total dose up to 400 Units divided among affected muscles ( 2.6 ) Adult Lower Limb Spasticity: Recommended total dose 300 Units to 400 Units divided across ankle and toe muscles ( 2.6 ) Pediatric Upper Limb Spasticity: Recommended total dose 3 Units/kg to 6 Units/kg (maximum 200 Units) divided among affected muscles (…
Onabotulinumtoxina side effects
The following adverse reactions to BOTOX (onabotulinumtoxinA) for injection are discussed in greater detail in other sections of the labeling: Spread of Toxin Effects [see Warnings and Precautions ( 5.1 )] Serious Adverse Reactions with Unapproved Use [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Contraindications ( 4 ) a nd Warnings and Precautions ( 5.4 )] Increased Risk of Clinically Significant Effects with Pre-Existing Neuromuscular Disorders [see Warnings and Precautions ( 5.5 )] Dysphagia and Breathing Difficulties [see Warnings and Precautions ( 5.6 )] Pulmonary Effects of BOTOX in Patients with Compromised Respiratory Status Treated for Spasticity or for Detrusor Overactivity Associated with a Neurologic Condition [see Warnings and Precautions ( 5.7 )] Corneal Exposure and Ulceration in Patients Treated with BOTOX for Blepharospasm [see Warnings and Precautions ( 5.8 )] Retrobulbar Hemorrhages in Patients Treated with BOTOX for Strabismus [see Warnings and Precautions ( 5.9 )] Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity [se e Warnings and Precautions ( 5.10 )] Autonomic Dysreflexia in Patients Treated for Detrusor Overactivity Associated with a Neurologic Condition [see Warnings and Precautions ( 5.11 )] Urinary Tract Infections in Patients with Overactive Bladder [see Warnings and Precautions ( 5.12 )]…
Who shouldn’t take onabotulinumtoxina
BOTOX is contraindicated: In patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions ( 5.4 )] . In the presence of infection at the proposed injection site(s). For intradetrusor injection in patients with a urinary tract infection; or in patients with urinary retention or post-void residual (PVR) urine volume >200 mL who are not routinely performing clean intermittent self-catheterization (CIC) [see Warnings and Precautions ( 5.12 , 5.13 )] . Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4 , 5.4 , 6 ) Infection at the proposed injection site ( 4 ) Intradetrusor Injections: Urinary tract infection or urinary retention ( 4 )
Onabotulinumtoxina drug interactions
Patients receiving concomitant treatment of BOTOX and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of BOTOX may be potentiated ( 7.1 , 7.4 ) 7.1 Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission Co-administration of BOTOX and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. 7.2 Anticholinergic Drugs Use of anticholinergic drugs after administration of BOTOX may potentiate systemic anticholinergic effects. 7.3 Other Botulinum Neurotoxin Products The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. 7.4 Muscle Relaxants Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX.
Every onabotulinumtoxina product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | No data | — | View → | |
| 2 | 72/100 | Prescription | Injectable | No data | — | View → |
How long onabotulinumtoxina keeps
No onabotulinumtoxina label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
What people report to the FDA about onabotulinumtoxina
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 213 reports naming onabotulinumtoxina, and the FDA flagged 70% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- headache16 reports
- constipation12 reports
- fatigue12 reports
- paraesthesia12 reports
- urethral haemorrhage11 reports
- nausea10 reports
- raynaud^s phenomenon10 reports
- muscular weakness8 reports
Read these as a signal, not a rate. A report does not mean onabotulinumtoxina caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is onabotulinumtoxina?
Botox (Onabotulinumtoxina) is a medication used to treat Blepharospasm, Dystonia, Fissure in Ano, Muscle Rigidity.
Can you take onabotulinumtoxina with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run onabotulinumtoxina against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is onabotulinumtoxina sold under?
We track 2 onabotulinumtoxina-containing products in the U.S.: Botox and Botox Cosmetic. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does onabotulinumtoxina come in?
Across the brands we track, onabotulinumtoxina is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic onabotulinumtoxina?
We do not currently list a generic-labelled onabotulinumtoxina product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Onabotulinumtoxina: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/onabotulinumtoxina
- MLA
- “Onabotulinumtoxina: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/onabotulinumtoxina.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for onabotulinumtoxina on DailyMed (NIH) ↗ — including its boxed warning in full.