Botox Side Effects

Generic name: onabotulinumtoxinA

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 25, 2023.

Note: This document provides detailed information about Botox Side Effects associated with onabotulinumtoxinA. Some dosage forms listed on this page may not apply specifically to the brand name Botox.

Applies to onabotulinumtoxinA: powder for solution.

Important warnings This medicine can cause some serious health issues

Injection route (powder for solution)

Distant spread of toxin effects - The effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.

These symptoms have been reported hours to weeks after injection.

Swallowing and breathing difficulties can be life threatening and there have been reports of death.

The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms.

Precautions

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require an immediate treatment in a hospital or clinic.

This medicine may make your muscles weak and cause vision problems (eg, bleeding inside the eye). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may reduce blinking of the eye which can lead to an increased risk of eye problems (eg, corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

After you have received this medicine and your vision or muscle spasms are better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, check with your doctor.

This medicine may increase your chances of having bronchitis or upper respiratory tract infections when given for upper limb spasticity. Tell your doctor right away if you have trouble breathing, sneezing, sore throat, coughing, or a fever.

This medicine may cause a condition called autonomic dysreflexia in patients with nervous system disorders (eg, spinal cord injury). It can be a life-threatening condition and requires immediate medical attention. Call your doctor right away if you have headache, increased sweating, slow heartbeat, warmth or redness in your face, neck, or arm, or have problems in urinating while using this medicine.

This medicine is made from donated human blood. Some human blood products have transmitted viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

Check with your doctor right away if you have difficulty urinating or a burning sensation while urinating after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Botox

Along with its needed effects, onabotulinumtoxinA (the active ingredient contained in Botox) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking onabotulinumtoxinA:

More common side effects

• difficulty with swallowing

Rare side effects

• difficulty with breathing or speaking
• muscle weakness

More common—for blepharospasm

• dryness of the eyes
• inability to close the eyelids completely

More common—for upper limb spasticity

• body aches or pain
• chills
• cough
• ear congestion
• fever
• headache
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

More common—for urinary incontinence caused by an overactive bladder

• bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

Less common—for blepharospasm

• decreased blinking
• irritation of the cornea (colored portion) of the eyes
• turning outward or inward of the edge of the eyelids

Less common—for forehead lines

• drooping of the brows and upper eyelids

Less common—for glabellar lines

• drooping of the upper eyelid
• facial pain
• muscle weakness
• partial or slight paralysis of the face

Less common—for lateral canthal lines

• swelling of the eyelids

Less common—for upper limb spasticity

• cough producing mucus
• difficulty breathing
• muscle weakness
• nausea
• seizures
• tightness in the chest
• weakness

Other side effects of Botox

Some side effects of onabotulinumtoxinA may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—for blepharospasm

• Blue or purplish bruise on the eyelids
• drooping of the upper eyelids
• irritation or watering of the eyes
• sensitivity of the eyes to light

More common—for cervical dystonia

• Body aches or pain
• chills
• cough
• ear congestion
• fever
• headache
• loss of voice
• neck pain
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

More common—for chronic migraine

• Neck pain

More common—for forehead lines

• Headache

More common—for hyperhidrosis

• Body aches or pain
• chills
• congestion
• cough
• diarrhea
• dryness or soreness of the throat
• fear
• fever
• general feeling of discomfort or illness
• headache
• heavy bleeding from the place where the shot was given
• itching skin
• joint pain
• loss of appetite
• nausea
• nervousness
• painful or difficult urination
• runny nose
• shivering
• sweating
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• voice changes
• vomiting

More common—for strabismus

• Drooping of the upper eyelid
• eye pointing upward or downward instead of straight ahead

More common—for upper limb spasticity

• Pain in the arms

Less common—for blepharospasm

• Skin rash
• swelling of the skin of the eyelid

Less common—for chronic migraine

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blurred vision
• body aches or pain
• cough producing mucus
• difficulty with breathing
• dizziness
• drooping of the upper eyelid
• headache
• muscle aches and pains
• nervousness
• pounding in the ears
• slow or fast heartbeat
• tightness in the chest

Less common—for forehead lines

• Skin tightness

Less common—for lower limb spasticity

• Back pain
• body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• sneezing
• sore throat
• stuffy nose
• unusual tiredness or weakness

Less common—for strabismus

• Difficulty finding the location of objects
• double vision

For healthcare professionals

Applies to onabotulinumtoxinA: injectable powder for injection.

General adverse events

The more commonly reported adverse reactions have included localized pain and headache, otherwise reactions vary based on condition being treated. Local weakness of the injected muscle(s) represents the expected pharmacological action while weakness of nearby muscle may also occur due to spread of toxin.^[Ref]

Gastrointestinal

• Very common (10% or more): Dysphagia (up to 19%)
• Common (1% to 10%): Constipation, nausea
• Uncommon (0.1% to 1%): Oral dryness
• Frequency not reported: Swallowing difficulties, jaw pain
• Postmarketing reports: Abdominal pain, diarrhea, dry mouth, vomiting, anorexia^[Ref]

Deaths as a complication of severe dysphagia have been reported with botulinum toxin. In cervical dystonia patients, dysphagia was reported in 19% of patients. Most dysphagia was reported as mild or moderate, however, dyspnea accompanied dysphagia in about 20% of these cases.^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection
• Common (1% to 10%): Bronchitis, cough, rhinitis, dyspnea, pharyngitis, rhinorrhea, nasal congestion
• Postmarketing reports: Aspiration pneumonia, respiratory depression and or/respiratory failure^[Ref]

Patients in the upper limb spasticity trials who had stable, reduced respiratory function at baseline experienced a greater event rate change in forced vital capacity (15% or greater or 20% or greater decline) compared with placebo at weeks 1, 6, and 12. These differences from placebo were not statistically significant, but noticeable. Among patients with restrictive lung disease of neuromuscular aetiology and detrusor overactivity associated with a neurologic condition, the event rate of decreased forced vital capacity (FVC) of 15% or 20% or more was also greater in treated patients compared with placebo. Bronchitis has been reported more frequently in patients treated for upper limb spasticity (3% vs 1%) compared with placebo. In patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were reported more frequently in treated patients compared with placebo (up to 11% vs 6%). In patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently compared with placebo (2% vs 1%). In pediatric patients treated for upper limb spasticity, upper respiratory tract infections were reported more frequently compared with placebo (17% [6 units/kg]; 10% [3 Units/kg]; 9% [placebo]).^[Ref]

Nervous system

• Common (1% to 10%): Headache, worsening migraine, facial paresis, dizziness, hypertonia, speech disorder, seizures
• Uncommon (0.1% to 1%): Vertigo
• Frequency not reported: VII nerve disorder
• Postmarketing reports: Brachial plexopathy, facial palsy, hypoesthesia, localized numbness, myasthenia gravis, paraesthesia, peripheral neuropathy, radiculopathy, syncope^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (up to 26%), urinary retention (up to 17%)
• Common (1% to 10%): Dysuria, hematuria, bacteriuria, residual urine volume

In trials in patients with overactive bladder (OAB), the more commonly reported adverse reactions within the first 12 weeks after intradetrusor injection were urinary tract infection (UTI; 18%), dysuria (9%), urinary retention (6%), bacteriuria (4%) and residual urine volume (3%). A higher incidence of UTI was observed in patients with diabetes than those without (31% vs 26%). The incidence of UTI increased in patients who experienced a maximum post-void residual (PVR) urine volume over 200 mL following injection compared to those whose PVR urine volume was 200 mL or less (44% vs 23%).

Among patients with detrusor overactivity associated with a neurologic condition, urinary tract infection and urinary retention occurred in 24% and 17%, respectively.

Musculoskeletal

• Common (1% to 10%): Pain in extremity, muscle weakness, asthenia, back pain, hypertonia, stiffness, fall, gait disturbance, muscle spasm, neck pain, musculoskeletal stiffness, myalgia
• Uncommon (0.1% to 1%): Jaw pain
• Postmarketing reports: Denervation/muscle atrophy, localized muscle twitching/involuntary muscle contractions, dysarthria,^[Ref]

Cardiovascular

Botulinum Toxin:

• Common (1% to 10%): Hypertension
• Frequency not reported: Arrhythmia, myocardial infarction (sometimes fatal)^[Ref]

Local

• Common (1% to 10%): Injection site pain^[Ref]

Ocular

• Very common (10% or more): Ptosis (up to 21%)
• Common (1% to 10%): Eyelid ptosis, brow ptosis, superficial punctate keratitis, dry eye
• Uncommon (0.1% to 1%): Eyelid edema, eye infection, diplopia, retrobulbar hemorrhage
• Very rare (less than 0.01%): Corneal perforation
• Frequency not reported: Irritation, tearing, lagophthalmos, photophobia, ectropion, keratitis, diplopia, local swelling of the eyelid skin lasting for several days following eyelid injection, reduced blinking (from the injection of the orbicularis muscle which may lead to serious corneal exposure), persistent epithelial defect
• Postmarketing reports: Visual disturbance, strabismus, blurred vision^[Ref]

Hypersensitivity

• Frequency not reported: Anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea

A fatal case of anaphylaxis has been reported; in this case, lidocaine was used as the diluent and therefore, the causal agent cannot be determined.

Other

• Common (1% to 10%): Fatigue, asthenia, fever,
• Frequency not reported: Focal facial paralysis, syncope, exacerbation of myasthenia gravis
• Postmarketing reports: Hypoacusis, hypoesthesia, malaise, radiculopathy, tinnitus^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus, skin tightness
• Frequency not reported: Diffuse skin rash
• Postmarketing reports: Alopecia (including madarosis), hyperhidrosis, pruritus, skin rash, erythema multiforme, dermatitis psoriasiform, psoriasiform eruption^[Ref]

Immunologic

• Common (1% to 10%): Flu syndrome, infection
• Frequency not reported: Immunogenicity (formation of neutralizing antibodies to botulinum toxin type A which may reduce the effectiveness of therapy)^[Ref]

Hematologic

• Common (1% to 10%): Hemorrhage^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety^[Ref]

See also:

Frequently asked questions

• Does Masseter Botox work for TMJ and jaw slimming?
• How many units of Botox do I need and what will it cost?
• Where do they inject Botox for migraines?
• Daxxify vs Botox​: Which should you use?
• Does Botox for migraines also help with wrinkles?
• What is Daxxify, the recent FDA-alternative to Botox?
• Xeomin vs Botox​: How do they compare?
• How much does Botox cost?
• Jeuveau vs Botox​: Which is best for you?

Further information

Botox side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer