The objective of this study was to assess child chloroquine ototoxicity after its use during the gestational period in systemic lupus erythematosus (SLE). Nineteen children over four years old were evaluated: nine were exposed to chloroquine diphosphate (CDP) during gestation and 10 were born from mothers that did not take this drug before conception or anytime during pregnancy (CONTROL). Pure tone audiometry was performed in all children and high and low frequency threshold means were compared to evaluate the hearing status. All nine mothers taking CDP were exposed to this drug at least during the first trimester of pregnancy (56% during the whole gestational period) and the mean time of CDP use was 6.1 +/- 2.9 months. No significant difference was found in children of CDP and CONTROL groups regarding age (7.6 +/- 4.4 versus 12.3 +/- 7.2 years; P = 0.10, respectively) and gender (P = 0.65). Pure tone high frequency thresholds, which are the first to be affected by ototoxic drugs, presented within normal limits in children exposed or not to CDP (8.5 +/- 5.0 versus 7.4 +/- 3.6 dBHL; P = 0.55, respectively). Likewise, the mean hearing thresholds at low frequencies were also similar in both groups (11.4 +/- 4.5 versus 11.9 +/- 3.0 dBHL; P = 0.66). In conclusion, child in utero exposure to chloroquine diphosphate does not seem to induce hearing impairment as measured by pure tone audiometry, reinforcing its safe use during pregnancy of lupus patients.