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NIACIN
DIR Classification
Classification:Moderate-DIR concern
Severity Score:3
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS
- Skeletal Muscle
- Rare cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥1 g/day) of nicotinic acid and HMG-CoA reductase inhibitors. Physicians contemplating combined therapy with HMG-CoA reductase inhibitors and nicotinic acid should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Periodic serum creatine phosphokinase (CPK) and potassium determinations should be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
55
42857
Other ADRs
36517
14080762
Odds Ratio = 0.495
Drug Property Information
ATC Code(s):
- C10BA01 - niacin
- C10BA - HMG CoA reductase inhibitors in combination with other lipid modifying agents
- C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
- C10 - LIPID MODIFYING AGENTS
- C - CARDIOVASCULAR SYSTEM
- C10AD52 - niacin
- C10AD - Nicotinic acid and derivatives
- C10A - "LIPID MODIFYING AGENTS, PLAIN"
- C10 - LIPID MODIFYING AGENTS
- C - CARDIOVASCULAR SYSTEM
- C04AC01 - niacin
- C04AC - Nicotinic acid and derivatives
- C04A - PERIPHERAL VASODILATORS
- C04 - PERIPHERAL VASODILATORS
- C - CARDIOVASCULAR SYSTEM
- C10AD02 - niacin
- C10AD - Nicotinic acid and derivatives
- C10A - "LIPID MODIFYING AGENTS, PLAIN"
- C10 - LIPID MODIFYING AGENTS
- C - CARDIOVASCULAR SYSTEM
Active Ingredient:niacin
Active Ingredient UNII:2679MF687A
Drugbank ID:DB00627
PubChem Compound:938
CAS Number:59-67-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
C1=CC(=CN=C1)C(=O)O
C1=CC(=CN=C1)C(=O)O
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
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