Articaine

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Medication side effect

Can Articaine cause paresthesia?

Yes — paresthesia has been reported as a side effect of Articaine in FDA adverse-event reports (FAERS) and product labeling. It is among the more frequently reported events for this medication. These are voluntary reports, so they show what's been reported, not how often it happens.

Reported adverse reactions

ADVERSE REACTIONS The most common adverse reaction was instillation site pain (incidence 24.5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Genomics at 855-242-9559 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled trials, the most common adverse reaction with CYKLX was instillation site pain reported in 24.5% (70/286) of subjects, compared to 6.9% (14/203) of subjects in the placebo group.

Warnings

WARNINGS AND PRECAUTIONS CYKLX is not for injection or intraocular administration ( 5.1 ) Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye ( 5.2 ) Corneal Opacification : Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss. ( 5.3 ) Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution ( 5.4 ) For Administration by Healthcare Provider : CYKLX is not intended for patient self-administration ( 5.5 ) 5.1 For Topical Ophthalmic Use CYKLX is not for injection or intraocular administration. 5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using CYKLX as accidental injuries can occur due to insensitivity of the eye. 5.3 Corneal Opacification Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss. 5.4 Risk of Contamination Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution. 5.5 For Administration by Healthcare Provider CYKLX is indicated for administration under the direct supervision of a healthcare provider. CYKLX is not intended for patient self-administration.

Other reported side effects of Articaine

hypoaesthesiahypoaesthesia oraldyspneanauseahypersensitivityanaphylactic reaction

Frequently asked questions

Is paresthesia a side effect of Articaine?

Yes — paresthesia has been reported as a side effect of Articaine in FDA adverse-event reports (FAERS) and/or its labeling. These are voluntary reports, so they show what's been reported, not how often it happens.

How common is paresthesia with Articaine?

paresthesia is among the more frequently reported events for Articaine in FAERS. Reporting volume isn't a true incidence rate — check the prescribing information for documented frequencies.

What should I do if I have paresthesia while taking Articaine?

Don't stop a prescribed medication on your own. Tell your prescriber or pharmacist — they can tell you whether it's expected, whether it needs attention, and what to do next.

Informational only, drawn from FDA adverse-event reporting (FAERS) and labeling — not medical advice, and not proof a medication caused an effect. Talk to your clinician or pharmacist about any side effect.

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