NIACIN ER (niacin)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Arterial hemorrhage
Disease of liver

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Alcohol use disorder
Peptic ulcer

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
30 day risk period post-myocardial infarction
Diabetes mellitus
Gout
Hypophosphatemia
Hypotension
Increased risk of bleeding due to coagulation disorder

There are 16 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Anaphylaxis Angioedema Atrial fibrillation Drug-induced hepatitis Dyspnea Edema Jaundice Laryngeal edema Laryngismus Macular retinal edema Myopathy Paresthesia Peptic ulcer Urticaria Vesicular rash

There are 39 less severe adverse reactions.

More Frequent	Less Frequent
Cough Diarrhea Dyspepsia Flushing Nausea Pruritus of skin Vomiting	Cardiac arrhythmia Dizziness Dry skin Exacerbation of peptic ulcer Hyperglycemia Hyperuricemia Hypophosphatemia Myalgia Syncope

Rare/Very Rare
Acquired acanthosis nigricans Blurred vision Chills Dyschromia Eructation Facial edema Flatulence General weakness Hyperhidrosis Hypoprothrombinemia Hypotension Insomnia Maculopapular rash Migraine Muscle weakness Nervousness Orthostatic hypotension Palpitations Peripheral edema Skin rash Stinging of skin Tachycardia Thrombocytopenic disorder

Animal reproduction studies have not been performed with niacin, and it is also not known whether the drug (at antilipemic dosages) can cause fetal harm or affect reproduction capacity when administered to pregnant women. Niacin should not be used in women who are or may become pregnant or in nursing women unless the possible benefits outweigh the potential risks. Currently, most experts recommend that hyperlipoproteinemias in pregnant women be managed with dietary measures; consultation with a lipid specialist may be indicated for pregnant women with severe forms of hyperlipidemia.

If the patient becomes pregnant while receiving niacin for primary hypercholesterolemia, the drug should be discontinued. If the patient being treated with niacin for hypertriglyceridemia or mixed dyslipidemia becomes pregnant, the benefits and risks of continued therapy should be assessed on an individual basis.

Drug/Drug Class	Severity	Precaution Description	Pregnancy Category Description
Niacin (> 50 Mg)	2	Not rec for lipid lowering tx; assess risk benefit for triglyceride lowering tx	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.

Niacin is distributed in human milk. Because of the potential for serious adverse effects in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Niacin	Excreted.This drug is known to be excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Potential adv effect on infant with lipid altering dose, mfg does not rec

No enhanced Geriatric Use information available for this drug.