Danocrine has an FDA Boxed Warning against its use in pregnancy. A pregnancy test that can detect early pregnancy is recommended to be taken before starting Danocrine. A non-hormonal form of contraception should be used during treatment. If a patient becomes pregnant during treatment with Danocrine, the medication should be stopped. Danocrine may have androgenic effects on a female fetus, including clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia. Danocrine also has the following FDA Boxed Warnings: Blood clots and events such as sagittal sinus thrombosis have been reported, along with strokes that are life-threatening or can cause death. Long-term Danocrine treatment experience is limited. Peliosis hepatitis and benign hepatic adenoma have occurred during long-term treatment. Danocrine may cause serious cases of benign intracranial hypertension. Patients experiencing papilledema, headache, nausea, vomiting, and vision problems should stop taking Danocrine and seek care by a neurologist. Before you start treatment with Danocrine, tell your doctor about:, All the medications you take, including prescription and over-the-counter medications., Your allergies., Your health problems and medical history., Your pregnancy or breastfeeding status., Blood clots, blood clotting disorders, and life-threatening strokes have occurred with the use of Danocrine., Liver problems, including benign liver lesions, can develop with long-term use of Danocrine., Increased pressure inside the skull can occur with Danocrine use. Early signs and symptoms include optic nerve swelling, headache, nausea, vomiting, and vision problems. Patients should seek emergency care right away if any of these effects occur., Patients should be screened for breast cancer before they start taking Danocrine., Fluid retention can occur with the use of Danocrine. Diabetic patients and patients with other conditions that can cause fluid retention should use caution., Dancorine may cause porphyria, a build up of chemicals that produce porphyrin. All the medications you take, including prescription and over-the-counter medications., Your allergies., Your health problems and medical history., Your pregnancy or breastfeeding status.
