Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Niacin
Drug ID BADD_D01559
Description Niacin is a B vitamin used to treat vitamin deficiencies as well as hyperlipidemia, dyslipidemia, hypertriglyceridemia, and to reduce the risk of myocardial infarctions.[L7550,L7553,L7556,L7559,L7562,L7565]
Indications and Usage Niacin is indicated to prevent vitamin deficiencies in pediatric and adult patients receiving parenteral nutrition as part of multivitamin intravenous injections.[L7550,L7553,L7556,L7559] Niacin oral tablets are indicated as a monotherapy or in combination with simvastatin or lovastatin to treat primary hyperlipidemia and mixed dyslipidemia.[L7562,L7565] It can also be used to reduce the risk of nonfatal myocardial infarctions in patients with a history of myocardial infarction and hyperlipidemia.[L7562,L7565] Niacin is also indicated with bile acid binding resins to treat atherosclerosis in patients with coronary artery disease and hyperlipidemia or to treat primary hyperlipidemia.[L7562,L7565] Finally niacin is indicated to treat severe hypertriglyceridemia.[L7562,L7565]
Marketing Status approved; investigational; nutraceutical
ATC Code C04AC01; C10AD02
DrugBank ID DB00627
KEGG ID D00049
MeSH ID D009525
PubChem ID 938
TTD Drug ID Not Available
NDC Product Code 72919-420; 59651-018; 59651-019; 62135-497; 71741-047; 47335-613; 50268-584; 62135-498; 65162-321; 65162-323; 68180-222; 68180-223; 62331-016; 68180-221; 71741-020; 47335-539; 47335-614; 71740-001; 71740-201; 62704-0027; 65162-322; 51552-0559; 62175-322; 33342-189; 59651-020; 62175-320; 25441-0095; 65372-1194; 33342-187; 51407-267; 51407-268
UNII 2679MF687A
Synonyms Niacin | Nicotinic Acid | 3-Pyridinecarboxylic Acid | 3 Pyridinecarboxylic Acid | Niacin Lithium Salt, Hemihydrate | Niacin Potassium Salt | Potassium Salt, Niacin | Niacin Sodium Salt | Sodium Salt, Niacin | Niacin Tartrate | Tartrate, Niacin | Niacin Copper (2+) Salt | Niacin Hydrochloride | Hydrochloride, Niacin | Niacin Iron (2+) Salt | Niacin Tosylate | Tosylate, Niacin | Niacin Zinc Salt | Nicamin | Nico-400 | Nico 400 | Nico400 | Nicobid | Nicocap | Nicolar | Nicotinate | Wampocap | Enduracin | Induracin | Niacin Calcium Salt | Lithium Nicotinate | Nicotinate, Lithium | Niacin Aluminum Salt | Aluminum Salt, Niacin | Niacin Ammonium Salt | Niacin Lithium Salt | Niacin Cobalt (2+) Salt | Niacin Magnesium Salt | Niacin Manganese (2+) Salt
Chemical Information
Molecular Formula C6H5NO2
CAS Registry Number 59-67-6
SMILES C1=CC(=CN=C1)C(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatotoxicity12.03.01.008; 09.01.07.0090.000191%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.0030.002365%
Hyperventilation22.02.01.006; 19.01.02.0040.000191%Not Available
Hypotension24.06.03.002--
Insomnia19.02.01.002; 17.15.03.002--
Jaundice23.03.03.030; 01.06.04.004; 09.01.01.004--Not Available
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.003--
Laryngospasm22.04.02.002--
Macular oedema06.04.06.005--Not Available
Maculopathy06.09.03.0070.000286%Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000191%
Myalgia15.05.02.0010.000610%
Myopathy15.05.05.001--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophagitis07.08.05.0010.000420%
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Pain of skin23.03.03.0030.000420%
Palpitations02.11.04.0120.000648%
Paraesthesia23.03.03.094; 17.02.06.005--
Peptic ulcer07.04.07.001--Not Available
Platelet count decreased13.01.04.001--
Prothrombin time prolonged13.01.02.012--Not Available
Pruritus23.03.12.0010.002555%
Rash23.03.13.0010.002555%Not Available
Rash maculo-papular23.03.13.004--
Rhabdomyolysis15.05.05.0020.000667%
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