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Fosinopril/hydrochlorothiazide has a boxed warning about its risk to cause morbidity and mortality in the baby when being used during pregnancy.

FDA modified its labeling on February, 2009 to include a precaution of drug interaction with gold. "Nitritoid reactions have been reported rarely in patients on therapy with injectable gold and concomitant ACE inhibitor therapy including Monopril/Monopril HCT."

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