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Review Hectorol Safety Reports submitted to FDA

Total Hectorol reports: 8.
Hectorol FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 4.
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FDA Reported Hectorol Side Effects: blood parathyroid hormone increased, accidental overdose, vomiting, vision blurred, nausea, diarrhoea, accidental exposure, pruritus, hyperhidrosis, dizziness, cardiac disorder.
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Hectorol Side Effects Report #5647878-1
Health Professional from UNITED STATES reported HECTOROL problem on Feb 20, 2008. Female patient was diagnosed with hyperparathyroidism secondary and was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: hospitalisation. HECTOROL dosage: unknown. Patient was hospitalized. Patient recovered.

Hectorol Side Effects Report #5498426-0
HECTOROL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 10, 2007. Male patient, 75 years of age, was diagnosed with hyperparathyroidism secondary and was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: cardiopulmonary failure, central nervous system infection, nipple pain. HECTOROL dosage: unknown. Patient died on 11/04/2006.

Hectorol Side Effects Report #5450917-4
Consumer or non-health professional from UNITED STATES reported HECTOROL problem on Aug 28, 2007. Female patient was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: accidental overdose, joint swelling, pitting oedema. HECTOROL dosage: unknown. During the same period patient was treated with DIDRONEL, METHADONE. Patient was hospitalized. Patient recovered.

Hectorol Side Effects Report #5466365-7
HECTOROL problem was reported by a Physician from UNITED STATES on Sept 11, 2007. Female patient was diagnosed with calcium metabolism disorder, fatigue and was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: accidental overdose. HECTOROL dosage: unknown. During the same period patient was treated with DIDRONEL, METHADONE. Patient was hospitalized. Patient recovered.

Hectorol Side Effects Report #5466366-9
Health Professional from UNITED STATES reported HECTOROL problem on Sept 11, 2007. Male patient, 43 years of age, weighting 185.2 lb, was diagnosed with hyperparathyroidism secondary and was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, blood parathyroid hormone increased, diarrhoea, nausea, vision blurred, vomiting. HECTOROL dosage: unknown. During the same period patient was treated with ZEMPLAR. Patient recovered.

Hectorol Side Effects Report #5407942-9
HECTOROL problem was reported by a Physician from UNITED STATES on July 24, 2007. Female patient, 45 years of age, was diagnosed with hyperparathyroidism secondary and was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: arteriovenous fistula site complication, bacteraemia, cardiovascular disorder, catheter related complication, catheter site discharge, haematocrit decreased, haemodialysis, haemoglobin decreased, staphylococcal infection. HECTOROL dosage: 0.25 MG. During the same period patient was treated with ACTIVASE, AMLODIPINE, ATORVASTATIN CALCIUM, EPOGEN. Patient was hospitalized. Patient recovered.

Hectorol Side Effects Report #5410299-0
Health Professional from UNITED STATES reported HECTOROL problem on July 27, 2007. Male patient, 43 years of age, weighting 185.2 lb, was diagnosed with hyperparathyroidism secondary and was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, diarrhoea, nausea, vision blurred, vomiting. HECTOROL dosage: unknown. During the same period patient was treated with ZEMPLAR. Patient recovered.

Hectorol Side Effects Report #5417390-3
HECTOROL problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 02, 2007. Male patient, 75 years of age, was diagnosed with hyperparathyroidism secondary and was treated with HECTOROL. After drug was administered, patient experienced the following problems/side effects: nipple pain. HECTOROL dosage: unknown. Patient died.


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hospitalisation, cardiopulmonary failure, central nervous system infection, nipple pain, accidental overdose, joint swelling, pitting oedema, , was diagnosed with hyperparathyroidism secondary and was diagnosed with hyperparathyroidism secondary and