A 38-year-old woman with type 1 diabetes underwent kidney-pancreas transpla
ntation. Her postoperative course was complicated due to recurrent acute gr
aft rejections and pancreatitis. After initial immunosuppression with micro
emulsion cyclosporine, mycophenolate, mofetil, and prednisone with muromona
b-CD3 induction, cyclosporine was switched to tacrolimus on day 44. The ini
tial dosage was 5 mg twice/day but it was gradually increased to 10 mg twic
e/day, aiming at 15-20 ng/ml. On day 17 of tacrolimus therapy the woman dev
eloped sudden hearing loss with tinnitus. The serum tacrolimus level was 28
.3 ng/ml (therapeutic range 10-20 ng/ml) on day 20 of tacrolimus therapy, a
nd peaked at 34.9 ng/ml on day 28. Two audiograms performed on days 28 and
29 confirmed bilateral hearing loss of 80% for speech perception, character
ized as mild to moderate sensorineural hearing loss with speech reception t
hreshold of 35 dB (normal < 20 dB) in both ears. The tacrolimus dosage was
gradually reduced to 6 mg twice/day by day 36, with drug level 9.7 ng/ml, a
fter which her hearing gradually recovered.