What the label lists and what reports show
Prilocaine side effects
Prilocaine's FDA label: “The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus …” FAERS holds 159 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 necrotising fasciitis (18 reports).
- Generic listed
Check it at the source: the prilocaine FDA label on DailyMed (effective November 10, 2021, Dentsply Pharmaceutical Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest.
From the label: adverse reactions, continuedSwelling and persistent paresthesia of the lips and oral tissues may occur. Persistent paresthesias lasting weeks to months, and in rare instances paresthesia lasting greater than one year, have been reported. Adverse experiences following the administration of prilocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or unintentional intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. …
Source: FDA drug label, ANDA079235 (Septodont Inc), as published by Dentsply Pharmaceutical Inc., effective November 10, 2021 (SPL set db23a56f-1e41-4843-9220-1b2e3059db41), via openFDA; the full label on DailyMed
What do FAERS reports show?
159 reports list prilocaine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 51 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 19 reactions below, 2 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.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- 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