What the label lists and what reports show

Lidocaine and prilocaine side effects

Lidocaine and prilocaine's FDA label: “The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).” FAERS holds 1,384 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (157 reports).

Generic listed

Check it at the source: the lidocaine and prilocaine FDA label on DailyMed (effective March 30, 2026, Padagis US LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).

From the label: adverse reactions, continued
Localized Reactions: During or immediately after treatment with Lidocaine and Prilocaine Cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of Lidocaine and Prilocaine Cream have been reported. The relationship to Lidocaine and Prilocaine Cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 Lidocaine and Prilocaine Cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions that were ascribed to Lidocaine and Prilocaine Cream. Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of Lidocaine and Prilocaine Cream. In patients treated with Lidocaine and Prilocaine Cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%. …

Source: FDA drug label, Padagis US LLC, effective March 30, 2026 (SPL set 6e1635f7-dcae-441b-bbf7-495661fb66ae), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,384 reports list lidocaine and prilocaine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 126 are coded as a death and 441 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Fatigue157
Nausea127
Diarrhoea107
Off Label Use (a use or a product term, not a reaction)95
Vomiting (named in the label)81
Dyspnoea70
Pyrexia70
Product Dose Omission Issue (a use or a product term, not a reaction)68
Death (an outcome recorded in the report)67
Headache66
Pain65
Dizziness (named in the label)64
Pneumonia62
Cough59
Drug Ineffective (a use or a product term, not a reaction)56
Nasopharyngitis54
Weight Decreased52
Decreased Appetite50
Arthralgia47
Sinusitis47
Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)43
Pruritus43
Asthenia41
Covid-1941
Rash (named in the label)37

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Lidocaine and prilocaine: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions