Hectorol Injection has been evaluated for safety in 70 patients with chronic renal disease on hemodialysis (who had been previously treated with oral Hectorol) from two 12-week, open-label, single-arm, multi-centered studies. (Dosage titrated to achieve target plasma iPTH levels, see CLINICAL PHARMACOLOGY / Clinical Studies .) Because there was no placebo group included in the studies of Hectorol Injection, Table 4 provides the adverse event incidence rates from placebo-controlled studies of oral Hectorol. Table 4: Adverse Events Reported by ≥2% of Hectorol® Treated Patients and More Frequently Than Placebo During the Double-blind Phase of Two Clinical Studies Adverse Event Hectorol® (n=61) % Placebo (n=61) % Body as a Whole Abscess 3.3 0.0 Headache 27.9 18.0 Malaise 27.9 19.7 Cardiovascular System Bradycardia 6.6 4.9 Digestive System Anorexia 4.9 3.3 Constipation 3.3 3.3 Dyspepsia 4.9 1.6 Nausea/Vomiting 21.3 19.7 Musculo-Skeletal System Arthralgia 4.9 0.0 Metabolic and Nutritional Edema 34.4 21.3 Weight increase 4.9 0.0 Nervous System Dizziness 11.5 9.8 Sleep disorder 3.3 0.0 Respiratory System Dyspnea 11.5 6.6 Skin Pruritus 8.2 6.6 A patient who reported the same medical term more than once was counted only once for that medical term. Potential adverse effects of Hectorol are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include: Early Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia. Late Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated serum aspartate transaminase (AST) and alanine transaminase (ALT), ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.