OpenClaim

Onabotulinumtoxina Side Effects

The most commonly reported side effects of onabotulinumtoxina include off label use, product preparation error, and therapeutic response decreased, based on 74,693 FDA adverse event reports from 2004 to 2025. 29.0% of reports found the drug to be ineffective.

Onabotulinumtoxina side effects

Percentages show how often each reaction appears relative to total reports for onabotulinumtoxina.

1
Drug Ineffective29.0%21,661
2
Off Label Use14.9%11,100
3
Drug Ineffective6.2%4,628
4
Product Preparation Error4.9%3,628
5
Therapeutic Response Decreased4.8%3,621
6
Headache4.6%3,454
7
Injection Site Pain3.8%2,868
8
Multiple Use Of Single-use Product3.7%2,798
9
Eyelid Ptosis3.1%2,281
10
Migraine2.9%2,159
11
Nausea2.4%1,805
12
Wrong Technique In Product Usage Process2.3%1,708
13
Pain2.2%1,676
14
Fatigue2.1%1,570
15
Dizziness2.0%1,506

These are voluntary reports and do not establish that onabotulinumtoxina caused these reactions.

Report severity

18.9%Serious14,136 reports
6.0%Hospitalizations4,502 reports
2.6%Fatal1,920 reports

Seriousness is determined by the reporter, not by OpenClaim.

Onabotulinumtoxina drug interactions

Other drugs that appear in adverse event reports alongside onabotulinumtoxina. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Erenumab-aooe1.7%1,303
2
Sodium-oxybate1.0%759
3
Topiramate0.9%693
4
Acetaminophen0.8%601
5
Amitriptyline-hydrochloride0.7%502
6
Galcanezumab-gnlm0.6%473
7
Gabapentin0.6%457
8
Diclofenac0.5%408
9
Ibuprofen0.5%407
10
Eptinezumab-jjmr0.5%398
11
Rizatriptan-benzoate0.5%372
12
Propranolol-hydrochloride0.5%366
13
Rimegepant0.5%347
14
Incobotulinumtoxina0.5%342
15
Venlafaxine0.4%313

Taken alongside

1
Acetaminophen3.0%2,250
2
Ergocalciferol2.9%2,160
3
Levothyroxine-sodium2.5%1,898
4
Gabapentin2.3%1,718
5
Topiramate2.0%1,492
6
Sumatriptan1.6%1,223
7
Aspirin1.6%1,219
8
Baclofen1.6%1,171
9
Albuterol1.5%1,132
10
Omeprazole1.5%1,089
11
Ondansetron1.4%1,081
12
Ibuprofen1.4%1,060
13
Clonazepam1.4%1,027
14
Fluticasone1.4%1,015
15
Duloxetine-hydrochloride1.3%979

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports onabotulinumtoxina side effects

72.6% of onabotulinumtoxina adverse event reports involve female patients and 10.5% involve male patients. The largest age group is adult at 83%. These figures reflect who reports side effects, not underlying risk.

Sex

Female72.6%
Male10.5%
Unknown16.9%

Age group

< 20.3%
2–111.2%
12–170.8%
18–6482.6%
65+15.1%

What is onabotulinumtoxina used for

Conditions and purposes for which patients were taking onabotulinumtoxina when the adverse event was reported.

Abdominal DistensionAbdominal PainAccidental ExposureAccidental Exposure To ProductAcneAcoustic NeuromaAcquired Claw ToeAcute Kidney InjuryAdverse Drug ReactionAdverse EventAicardi's SyndromeAllergy TestAllodyniaAlopeciaAmyotrophic Lateral Sclerosis

Showing 15 of 900 indications

Onabotulinumtoxina brand names and reporting trend

Onabotulinumtoxina is sold under the brand name Botox.

Brand names

Botox230

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking onabotulinumtoxina with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.