What are the possible side effects of Nicotinic Acid?
Get emergency medical help if you have any of these signs of an allergic reaction to Nicotinic Acid: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
feeling like you might pass out;
fast, pounding, or uneven heart beats;
feeling short of breath;
jaundice (yellowing of your skin or eyes); or
muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.
If you are diabetic, tell your doctor about any changes in your blood sugar levels.
Less serious side effects of Nicotinic Acid include:
warmth, redness, or tingly feeling under your skin;
itching, dry skin;
sweating or chills;
nausea, diarrhea, belching, gas;
muscle pain, leg cramps; or
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Nicotinic Acid in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
In the placebo-controlled clinical trials database of 402 patients (age range 21 to 75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% of patients on Nicotinic Acid extended-release tablets and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Nicotinic Acid extended-release tablets that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs. 0%), rash (2% vs. 0%), diarrhea (2% vs. 0%), nausea (1% vs. 0%), and vomiting (1% vs. 0%). The most commonly reported adverse reactions (incidence > 5% and greater than placebo) in the Nicotinic Acid extended-release tablets controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus.
In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for Nicotinic Acid extended-release tablets. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, 6% (14/245) of Nicotinic Acid extended-release tablet patients discontinued due to flushing. In comparisons of immediate-release (IR) Nicotinic Acid and Nicotinic Acid extended-release tablets, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Nicotinic Acid extended-release tablets. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4 week period averaged 8.6 events per patient for IR Nicotinic Acid versus 1.9 following Nicotinic Acid extended-release tablets.
Other adverse reactions occurring in ≥ 5% of patients treated with Nicotinic Acid extended-release tablets and at an incidence greater than placebo are shown in Table 2 below.
Table 2. Treatment-Emergent Adverse Reactions by Dose Level in ≥ 5% of Patients and at an Incidence Greater Than Placebo; Regardless of Causality Assessment in Placebo-Controlled Clinical Trials
Pooled results from placebo-controlled studies; for Nicotinic Acid extended-release tablets, n = 245 and median treatment duration = 16 weeks. Number of Nicotinic Acid extended-release tablet patients (n) are not additive across doses.
Adverse reactions are reported at the initial dose where they occur.
The 500 mg/day dose is outside the recommended daily maintenance dosing range.
10 patients discontinued before receiving 500 mg, therefore they were not included.
Note: Percentages are calculated from the total number of patients in each column.
In general, the incidence of adverse events was higher in women compared to men.
Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH)
In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40 to 80 mg/dL, and were randomized to receive Nicotinic Acid extended-release tablets 1500 to 2000 mg/day (n = 1718) or matching placebo (IR Nicotinic Acid, 100 to 150 mg, n = 1696). The incidence of the adverse reactions of “blood glucose increased” (6.4% vs. 4.5%) and “diabetes mellitus” (3.6% vs. 2.2%) was significantly higher in the simvastatin plus Nicotinic Acid extended-release tablets group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus Nicotinic Acid extended-release tablets group and one (< 0.1%) in the simvastatin plus placebo group.
Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval use of Nicotinic Acid extended-release tablets:
Chemistry: Elevations in serum transaminases, LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus.
Hematology: Slight reductions in platelet counts and prolongation in prothrombin time.
To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email email@example.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What is the most important information I should know about Nicotinic Acid?
Nicotinic Acid controlled-release tablets may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Nicotinic Acid controlled-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Nicotinic Acid controlled-release tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
Do NOT take more than the recommended dose without checking with your doctor.
Nicotinic Acid controlled-release tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
Do not substitute Nicotinic Acid controlled-release tablets for any other type of Nicotinic Acid without talking with your doctor. Severe liver damage can occur.
If you stop taking Nicotinic Acid controlled-release tablets for an extended period, contact your doctor before you start taking it again. Your dose may need to be adjusted.
Tell your doctor or dentist that you take Nicotinic Acid controlled-release tablets before you receive any medical or dental care, emergency care, or surgery.
Follow the diet and exercise program given to you by your health care provider.
Flushing occurs with Nicotinic Acid controlled-release tablets and may last for several hours. Take Nicotinic Acid controlled-release tablets at bedtime so that flushing will occur during sleep, unless your doctor tells you otherwise. If you are awakened by flushing at night, get up slowly, especially if you feel dizzy or faint, or if you are taking blood pressure medicines. Taking aspirin 30 minutes before you take Nicotinic Acid controlled-release tablets may lessen flushing. Talk with your doctor to see if you should take aspirin before you take Nicotinic Acid controlled-release tablets or if flushing becomes bothersome.
Diabetes patients - Nicotinic Acid controlled-release tablets may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
Diabetes patients - Nicotinic Acid controlled-release tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.
Nicotinic Acid controlled-release tablets may interfere with certain lab tests, including plasma or urinary catecholamine tests or urine glucose tests. Be sure your doctor and lab personnel know you are taking Nicotinic Acid controlled-release tablets.
Lab tests, including liver function, blood glucose, blood potassium, and serum creatine phosphokinase, may be performed while you use Nicotinic Acid controlled-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Nicotinic Acid controlled-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
Nicotinic Acid controlled-release tablets should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Nicotinic Acid controlled-release tablets while you are pregnant. Nicotinic Acid controlled-release tablets is found in breast milk. Do not breast-feed while taking Nicotinic Acid controlled-release tablets.
Nicotinic Acid contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
Nicotinic Acid extended-release tablets are contraindicated in the following conditions:
Active liver disease or unexplained persistent elevations in hepatic transaminases
Patients with active peptic ulcer disease
Patients with arterial bleeding
Hypersensitivity to Nicotinic Acid or any component of this medication
DailyMed. "NIACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DTP/NCI. "nicotinic acid: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Nicotinic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Nicotinic Acid are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Nicotinic Acid. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effects
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