Nicotine
/api/v1/drug/nicotineMechanism of action
Sourced from openFDAMechanism-of-action class: Cholinergic Nicotinic Agonists.
Indications
Sourced from openFDA- Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Dosage & administration
Sourced from openFDADirections if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. repeat this process until most of the tingle is gone (about 30 minutes) do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
Warnings & precautions
Sourced from openFDAIf you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase blood pressure. stomach ulcer or diabetes history of seizures Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if mouth, teeth or jaw problems occur irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.
Approval history
Sourced from openFDA- Jan 13, 1984NDANDA018612Haleon Us Holdings
- Nov 7, 1991NDANDA020165Chattem Sanofi
- Nov 27, 1991NDANDA020076Dr Reddys Labs Sa
- Jun 8, 1992NDANDA020066Haleon Us Holdings
- Mar 22, 1996NDANDA020385Pfizer Inc
- Oct 20, 1997ANDAANDA074612Difgen Pharms
- Oct 31, 2002NDANDA021330Haleon Us Holdings
- May 18, 2009NDANDA022360Haleon Us Holdings
FAERS reports
- 1Drug Ineffective7,53613%
- 2Nicotine Dependence6,16110%
- 3Nausea4,6497.7%
- 4Intentional Drug Misuse3,7826.3%
- 5Application Site Erythema3,5535.9%
- 6Application Site Pruritus3,5005.8%
- 7Dizziness2,6034.3%
- 8Product Quality Issue2,4964.1%
- 9Malaise2,3874.0%
- 10Product Adhesion Issue2,1783.6%
- 11Headache2,1593.6%
- 12Vomiting1,7572.9%
- 13Wrong Technique In Product Usage Process1,7322.9%
- 14Overdose1,6812.8%
- 15Treatment Noncompliance1,5902.6%
Literature
Recent PubMed references pinned to Nicotine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Effects of Nicotine administration on α7nAChR, miR-124, STAT3, and inflammatory markers in Rat Lung Tissue.Molecular biology reports · 2026 · Dastmalchi N, Asaadi F, Karimi-Sales E, et al.PMID 42262606DOI 10.1007/s11033-026-12126-w
- Healthcare providers' beliefs about the health effects of nicotine and electronic cigarettes.PloS one · 2026 · Jonik S, Berger D, Hrabovsky S, et al.PMID 42228747DOI 10.1371/journal.pone.0330962
- Nicotine Risk Education and Its Impact on Knowledge, Perceptions, and Behavioral Intentions: A Scoping Review of U.S. Studies.International journal of environmental research and public health · 2026 · Imran R, Patel A, Snell M, et al.PMID 42196728DOI 10.3390/ijerph23050636
- Nicotine Is Associated with Improved Histological and Biochemical Indices of Oral Ulcer Repair in an Acetic Acid-Induced Rat Model.Medicina (Kaunas, Lithuania) · 2026 · Hengirmen Acu İ, Erbaş OPMID 42195153DOI 10.3390/medicina62050900
- The neurophysiological effects of nicotine and research progress.Chemico-biological interactions · 2026 · Liu Y, Wei H, Zhang J, et al.PMID 42176769DOI 10.1016/j.cbi.2026.112148
- Genetic variation in cerebellar nicotinic acetylcholine receptor (nAChR) function impacts efficacy of nicotine and varenicline treatment of alcohol withdrawal-induced motor impairment.Neuropharmacology · 2026 · McLean NA, Greenway AE, Gray TL, et al.PMID 42162603DOI 10.1016/j.neuropharm.2026.111029
- Adolescent Exposure to Nicotine and Ethanol Attenuates Adult Nicotine Reward Sensitivity in Rats.Neuropsychopharmacology reports · 2026 · Toyoshima M, Toyofuku R, Shimoda S, et al.PMID 42157642DOI 10.1002/npr2.70132
- Nicotine biosynthesis is completed by cryptic activating glucosylation.Nature communications · 2026 · Schwabe BTW, Angstman IM, Vollheyde K, et al.PMID 42151135DOI 10.1038/s41467-026-72705-0
Clinical trials
The 10 most recently updated of 2,418 ClinicalTrials.gov registrations naming Nicotine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Behavioral Exposure for Introceptive Tolerance RCTRecruiting · Interventional · 146 enrolled · Rutgers, The State University of New JerseyNCT05398276updated 2026-06-12
- Using Smartwatches to Monitor Smoking in Real-life SituationsEnrolling by invitation · Observational · 30 enrolled · National Institute on Minority Health and Health Disparities (NIMHD)NCT07067151updated 2026-06-12
- Phone Enabled Implementation of Cessation SupportRecruiting · Interventional · 1,500 enrolled · University of FloridaNCT05628389updated 2026-06-12
- Young Adult Tobacco/Nicotine and Cannabis Co-useRecruiting · Interventional · 350 enrolled · Medical University of South CarolinaNCT06239350updated 2026-06-12
- Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to QuitRecruiting · Interventional · 472 enrolled · Abramson Cancer Center at Penn MedicineNCT07199517updated 2026-06-11
- Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking CessationActive not recruiting · Interventional · 85 enrolled · M.D. Anderson Cancer CenterNCT02697227updated 2026-06-11
- Addictive Threshold of NicotineRecruiting · Early phase 1 · Interventional · 45 enrolled · Yale UniversityNCT06096714updated 2026-06-11
- Thrive With Type 1 Diabetes 2026Recruiting · Interventional · 48 enrolled · Emory UniversityNCT07522866updated 2026-06-11
- Sensory and Behavioral Sleep TrainingRecruiting · Interventional · 54 enrolled · Atlas UniversityNCT07638605updated 2026-06-10
- Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)Active not recruiting · Phase 2 · Phase 3 · Interventional · 200 enrolled · State University of New York at BuffaloNCT06822049updated 2026-06-10
Pharmacogenomics
CPIC-curated drug–gene pairs for Nicotine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.
- CHRNA3CPIC D (provisional)ClinPGx 3
- COMTCPIC C/D (provisional)ClinPGx 3
Frequently asked questions
- How does Nicotine work?
- Mechanism-of-action class: Cholinergic Nicotinic Agonists.
- What is Nicotine used for?
- According to FDA labeling, Nicotine carries indications including: Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Nicotine?
- Nicotine is classified as Drugs used in nicotine dependence, Cholinergic Nicotinic Agonist, Cholinergic Nicotinic Agonists, Increased Central Nervous System Acetylcholine Activity, Increased Medullary Respiratory Drive, Increased Muscular System Acetylcholine Activity, Increased Peripheral Nervous System Acetylcholine Activity.
- What are the brand names for Nicotine?
- Nicotine is marketed under brand names including Habitrol, Nicduic, Nicoderm C-Q, Nicorelief, Nicorette, Nicotrol, Thrive.
nicotine 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.