MedDRA preferred term

Nicotine dependence: adverse event reports recording this term

7,751 reports to FDA record it, 2004–2026; 0% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

7,751
reports recording the term: 0% of all reports; 82
reports, 12 months to June 2026: 96 in the 12 months before; 20.1%
marked serious by the reporter: 57.4% across all reports; 0.7%
record death among outcomes, as reported: 9.1% across all reports

"Nicotine dependence" is a MedDRA preferred term recorded in 7,751 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

82 reports recorded it in the 12 months to June 2026, down 15% from 96 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 20.1% are marked serious, 0.7% include death among the outcomes and 4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Nicorette, Nicoderm Cq and Nicotine polacrilex. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Nicorette	Cholinergic nicotinic agonist	2,437	19.5%
Nicoderm Cq	Cholinergic nicotinic agonist	1,375	8.9%
Nicotine polacrilex	Cholinergic nicotinic agonist	846	10.8%
Nicotine transdermal system patch	Cholinergic nicotinic agonist	800	17.9%
Nicotine	Cholinergic nicotinic agonist	704	7.8%
Commit	—	442	9.5%
Chantix	Partial cholinergic nicotinic agonist	87	0.1%
Bupropion hydrochloride	Aminoketone	75	0.3%
Nicorette Fruit Chill	Cholinergic nicotinic agonist	70	20.2%
Nicorette Otc	—	61	23.9%
Nicotinell	—	55	10.7%
Nicorette White Ice Mint	Cholinergic nicotinic agonist	48	13.2%
Prednisone	Corticosteroid	47	0%
Equate Nicotine	Cholinergic nicotinic agonist	46	2.7%
Calcium carbonate	Blood coagulation factor	45	0.5%
Alvesco	—	43	1%
Ativan	Benzodiazepine	43	0.8%
Breo Ellipta	Corticosteroid	43	0.2%
Cefuroxime axetil	Cephalosporin antibacterial	43	2%
Ergocalciferol	Provitamin D2 compound	42	0.4%
Aripiprazole	Atypical antipsychotic	38	0.1%
Wellbutrin	Aminoketone	37	0.3%
Hizentra	Human immunoglobulin G	30	0.1%
Citalopram	Serotonin reuptake inhibitor	29	0.1%
Citalopram hydrobromide	Serotonin reuptake inhibitor	29	0.3%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Cholinergic nicotinic agonist	6,253	11.5%	8.4%
Aminoketone	132	0.2%	0.2%
Atypical antipsychotic	115	0%	0%
Proton pump inhibitor	107	0%	0%
Corticosteroid	102	0%	0%
Partial cholinergic nicotinic agonist	87	0.1%	0.1%
Serotonin reuptake inhibitor	74	0%	0%
Fluoroquinolone antibacterial	71	0.1%	0%
Cephalosporin antibacterial	67	0.1%	0%
Benzodiazepine	63	0%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20%2

2 to 110%2

12 to 170.1%6

18 to 4411.6%901

45 to 6426.3%2,035

65 to 749.6%746

75 and over3.3%255

Age not given49.1%3,804

Patient sex

Female52.7%4,082

Male32.1%2,486

Not given15.3%1,183

Grey bar: all 20,646,523 reports in the database. 88.3% of these reports give the United States as the country.

Questions about "Nicotine dependence"

What does "Nicotine dependence" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record nicotine dependence?

7,751 reports through June 2026 (0% of all reports), 82 of them in the latest 12 months.

Which drugs appear most often in these reports?

Nicorette (2,437), Nicoderm Cq (1,375), Nicotine polacrilex (846), Nicotine transdermal system patch (800) and Nicotine (704). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.