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Review Niacin Safety Reports submitted to FDA

Total Niacin reports: 7.
Niacin FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Niacin Side Effects: nausea, flushing, weight decreased, abdominal pain upper, rash erythematous, heart rate increased, jaundice, gamma-glutamyltransferase increased, carbohydrate antigen 19-9 increased, blood alkaline phosphatase increased, rash.
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Niacin Side Effects Report #5669830-2
Pharmacist from UNITED STATES reported NIACIN problem on Mar 14, 2008. Male patient, 68 years of age, was treated with NIACIN. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity, jaundice, prothrombin level abnormal. NIACIN dosage: 1000MG QHS PO. During the same period patient was treated with PRAVASTATIN. Patient was hospitalized. Patient recovered.

Niacin Side Effects Report #5682792-7
NIACIN problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 26, 2008. Female patient, 52 years of age, weighting 243.0 lb, was diagnosed with blood triglycerides increased and was treated with NIACIN. After drug was administered, patient experienced the following problems/side effects: chest pain, dizziness, fall, feeling hot, loss of consciousness. NIACIN dosage: unknown. Patient was hospitalized. Patient recovered.

Niacin Side Effects Report #5573417-X
Health Professional from UNITED STATES reported NIACIN problem on Dec 20, 2007. Male patient, 59 years of age, was diagnosed with hyperlipidaemia and was treated with NIACIN. After drug was administered, patient experienced the following problems/side effects: anxiety, burning sensation, dyspnoea, pruritus, tearfulness. NIACIN dosage: 1000MG HS PO. Patient recovered.

Niacin Side Effects Report #5463094-0
NIACIN problem was reported by a Pharmacist from UNITED STATES on Sept 18, 2007. Male patient, 59 years of age, was diagnosed with hyperlipidaemia and was treated with NIACIN. After drug was administered, patient experienced the following problems/side effects: nausea, rash, vomiting. NIACIN dosage: unknown. Patient recovered.

Niacin Side Effects Report #5466919-8
Consumer or non-health professional from UNITED STATES reported NIACIN problem on Sept 21, 2007. Male patient, weighting 175.0 lb, was treated with NIACIN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, convulsion, pulse pressure decreased. NIACIN dosage: unknown. Patient was hospitalized. Patient recovered.

Niacin Side Effects Report #5382652-5
NIACIN problem was reported by a Pharmacist from UNITED STATES on July 05, 2007. Male patient, 50 years of age, was diagnosed with hyperlipidaemia and was treated with NIACIN. After drug was administered, patient experienced the following problems/side effects: flushing. NIACIN dosage: 500MG TID PO. Patient recovered.

Niacin Side Effects Report #5382652-5
Pharmacist from UNITED STATES reported NIACIN problem on July 05, 2007. Male patient, 50 years of age, was diagnosed with hyperlipidaemia and was treated with NIACIN. After drug was administered, patient experienced the following problems/side effects: flushing. NIACIN dosage: 500MG TID PO. Patient recovered.


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hepatotoxicity, jaundice, prothrombin level abnormal, chest pain, dizziness, fall, feeling hot, loss of consciousness, , was diagnosed with blood triglycerides increased and was diagnosed with hyperlipidaemia and was diagnosed with hyperlipidaemia and