Niacinamide
/api/v1/drug/niacinamideMechanism of action
Sourced from openFDAMechanism-of-action classes: Enzyme Activators; Enzyme Interactions.
Indications
Sourced from openFDA- After showering, wipe off excess water and spray the product evenly 2-3 times on the desired area (except the face) at a distance of 15-20cm.
Dosage & administration
Sourced from openFDAtopical use only
Warnings & precautions
Sourced from openFDA1. During using product or after use, if there are any abnormal symptoms or side effects such as red spots, swelling or itching in the area of use due to direct sunlight, consult with a specialist. 2. Refrain from using on areas with scars, etc. 3. Precautions for storage and handling A) Keep out of reach of children B) Store away from direct sunlight
Approval history
Sourced from openFDA- Feb 21, 2001NDANDA021265Sandoz Canada Inc
- Apr 9, 2026ANDAANDA210273Apotex
- Apr 9, 2026ANDAANDA210672Apotex
FAERS reports
- 1Fatigue3,42911%
- 2Nausea2,3187.4%
- 3Diarrhoea2,3027.4%
- 4Headache2,1336.8%
- 5Pain1,8395.9%
- 6Drug Ineffective1,7325.5%
- 7Dizziness1,6855.4%
- 8Dyspnoea1,5555.0%
- 9Arthralgia1,4854.8%
- 10Asthenia1,4364.6%
- 11Off Label Use1,4004.5%
- 12Fall1,2924.1%
- 13Weight Decreased1,1233.6%
- 14Vomiting1,1053.5%
- 15Insomnia1,0973.5%
Literature
Recent PubMed references pinned to Niacinamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- [Sleep disorders and chronic cerebral ischemia].Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova · 2026 · Putilina MVPMID 42268271DOI 10.17116/jnevro202612605242
- AFP Stimulates Glucose Metabolic Reprogramming Contributing to Hepatocellular Carcinoma Resist Sorafenib Through Activating PI3K/AKT Signalling Pathway.Journal of cellular and molecular medicine · 2026 · Zhou Y, Feng S, Chen Y, et al.PMID 42244055DOI 10.1111/jcmm.71226
- Exploring Synergistic Potential of Sorafenib and Atorvastatin to Launch Apoptosis and Ferroptosis-driven Mixed Cell Death Mechanism in Colorectal Cancer.AAPS PharmSciTech · 2026 · Yadav V, Dighe S, Dhake P, et al.PMID 42204072DOI 10.1208/s12249-026-03461-z
- Identification of Changes in the Transcriptome Profile of Human Hepatoma HepG2 Cells Exposed to Combined Sorafenib and Cannabis Treatment.International journal of molecular sciences · 2026 · Udomkritayachai K, Thiamsuk T, Jarujamrat T, et al.PMID 42196320DOI 10.3390/ijms27104342
- Astragaloside IV Reduces Sorafenib-Induced Cardiotoxicity by Inhibiting Apoptosis Through the STAT3/HIF-1α/Bcl-2 Signaling Pathway.International journal of molecular sciences · 2026 · Wang L, Liu B, You Q, et al.PMID 42196224DOI 10.3390/ijms27104243
- Deciphering Lipid Metabolic Landscape of Sorafenib-Treated Hepatocellular Carcinoma by Mass Spectrometry Imaging and Transcriptomics.Biomolecules · 2026 · Li D, Tuo Y, Sai L, et al.PMID 42194025DOI 10.3390/biom16050675
- Nicotinamide Ameliorates Deoxynivalenol-Induced Injury in Renal Cells via Inhibiting PARP1 Hyperactivation and Restoring NAD(+) Homeostasis.Toxins · 2026 · Chen C, Qin Y, Luo Z, et al.PMID 42188629DOI 10.3390/toxins18050227
- Dual Effects of Nicotinamide on Aging-Related Arrhythmia: Protective at Low Dose, Proarrhythmic at Higher Doses.Journal of the American Heart Association · 2026 · Hu L, Qi X, Hu Y, et al.PMID 42179277DOI 10.1161/JAHA.125.046761
Clinical trials
The 10 most recently updated of 1,437 ClinicalTrials.gov registrations naming Niacinamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell CancerActive not recruiting · Phase 2 · Interventional · 48 enrolled · M.D. Anderson Cancer CenterNCT00494182updated 2026-06-12
- A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face HyperpigmentationCompleted · Interventional · 18 enrolled · Revision SkincareNCT07644871updated 2026-06-12
- Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients With Mild to Moderately Active Ulcerative ColitisRecruiting · Phase 2 · Phase 3 · Interventional · 459 enrolled · University Hospital Schleswig-HolsteinNCT06488625updated 2026-06-11
- Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell TransplantActive not recruiting · Phase 1 · Phase 2 · Interventional · 74 enrolled · M.D. Anderson Cancer CenterNCT03247088updated 2026-06-10
- Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib AloneCompleted · Phase 3 · Interventional · 459 enrolled · SillaJen, Inc.NCT02562755updated 2026-06-08
- Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell TransplantationRecruiting · Early phase 1 · Interventional · 20 enrolled · Case Comprehensive Cancer CenterNCT04332341updated 2026-06-05
- A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant RecipientsRecruiting · Early phase 1 · Interventional · 20 enrolled · Marissa LoblNCT07286318updated 2026-06-05
- Pathways of Eicosanoid MetabolismEnrolling by invitation · Early phase 1 · Interventional · 10 enrolled · Vanderbilt UniversityNCT04464070updated 2026-06-05
- Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKDActive not recruiting · Phase 2 · Interventional · 118 enrolled · University of Colorado, DenverNCT04040959updated 2026-06-05
- Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black WomenRecruiting · Interventional · 60 enrolled · Hospital Israelita Albert EinsteinNCT07618572updated 2026-06-04
Frequently asked questions
- How does Niacinamide work?
- Mechanism-of-action classes: Enzyme Activators; Enzyme Interactions.
- What is Niacinamide used for?
- According to FDA labeling, Niacinamide carries indications including: After showering, wipe off excess water and spray the product evenly 2-3 times on the desired area (except the face) at a distance of 15-20cm.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Niacinamide?
- Niacinamide is classified as Other plain vitamin preparations, Enzyme Activators, Enzyme Interactions, Cellular Activity Alteration, Decreased Cholesterol Synthesis, Decreased Lipogenesis, Glucose Metabolism Alteration, Increased Glycogenolysis, Increased Metabolic Rate, Lipid Metabolism Alteration.
- What are the brand names for Niacinamide?
- Niacinamide is marketed under brand names including Dialyvite 800, Dialyvite 800 with Iron, Dialyvite 800 with Zinc, Eldertonic, Ellis Tonic, Hemocyte Plus, Infuvite, Infuvite Pediatric.
niacinamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.