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Daxxify Side Effects

Generic name: daxibotulinumtoxinA

Medically reviewed by Drugs.com. Last updated on Sep 28, 2023.

Note: This document contains side effect information about daxibotulinumtoxinA. Some dosage forms listed on this page may not apply to the brand name Daxxify.

Applies to daxibotulinumtoxinA: intramuscular powder for solution.

Warning

Intramuscular route (Powder for Solution)

The effects of all botulinum toxin products, including daxibotulinumtoxinA-lanm, 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, an unapproved use for daxibotulinumtoxinA-lanm, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms

Serious side effects of Daxxify

Along with its needed effects, daxibotulinumtoxinA (the active ingredient contained in Daxxify) 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 daxibotulinumtoxinA:

Less common

Incidence not known

Other side effects of Daxxify

Some side effects of daxibotulinumtoxinA 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

Incidence not known

For Healthcare Professionals

Applies to daxibotulinumtoxinA: intramuscular powder for injection.

General

The most frequently reported side effects included injection site reactions, headache, eyelid ptosis, facial paresis, muscular weakness, and upper respiratory tract infection.[Ref]

Cardiovascular

Common (1% to 10%): Atrioventricular block (First degree)

Frequency not reported: Cardiovascular system adverse reactions[Ref]

Cardiovascular system adverse reactions included arrhythmias and myocardial infarction.[Ref]

Dermatologic

Common (1% to 10%): Erythema[Ref]

Gastrointestinal

Frequency not reported: Dysphagia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Immunologic

-Treatment emergent binding antibodies were reported to be developed against this drug and RTP004 (amino acid excipient).

-Two individuals who previously had botulinum toxin treatment tested positive for neutralizing antibodies.[Ref]

Common (1% to 10%): Anti-drug antibodies[Ref]

Local

Injection site reactions included injection site pain, injection site erythema, injection site edema, injection site bruising, injection site hematoma, injection site papule, and injection site pruritus.[Ref]

Common (1% to 10%): Injection site reactions[Ref]

Musculoskeletal

Common (1% to 10%): Muscular weakness, musculoskeletal pain, arthralgia, spinal pain[Ref]

Nervous system

Facial paresis includes facial asymmetry.[Ref]

Common (1% to 10%): Facial paresis, headache

Frequency not reported: Neuromuscular compromise[Ref]

Ocular

Ophthalmic adverse reactions included dry eye (eye irritation, photophobia, or visual changes).[Ref]

Common (1% to 10%): Eyelid ptosis

Frequency not reported: Ophthalmic adverse reactions[Ref]

Other

Spread of toxin effect included asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties.[Ref]

Common (1% to 10%): Edema

Frequency not reported: Spread of toxin effect[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection

Frequency not reported: Breathing difficulties[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions[Ref]

Hypersensitivity reactions included anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea.[Ref]

Frequently asked questions

References

1. Product Information. Daxxify (daxibotulinumtoxinA). Revance Therapeutics, Inc. 2022;1.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.