Hectoral Side Effects
Please note - some side effects for Hectoral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Hectoral Side Effects - for the Professional
Hectoral
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.
| 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.
TopDisclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
