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Nicotine Side Effects

The most commonly reported side effects of nicotine include nicotine dependence, intentional drug misuse, and nausea, based on 65,407 FDA adverse event reports from 2004 to 2025. 10.5% of reports found the drug to be ineffective.

Nicotine side effects

Percentages show how often each reaction appears relative to total reports for nicotine.

1
Drug Ineffective10.5%6,880
2
Nicotine Dependence6.8%4,469
3
Intentional Drug Misuse5.2%3,421
4
Nausea4.7%3,051
5
Application Site Pruritus3.7%2,444
6
Application Site Erythema3.6%2,365
7
Product Quality Issue3.6%2,330
8
Nicotine Dependence3.4%2,192
9
Product Adhesion Issue3.3%2,169
10
Nausea3.1%2,033
11
Wrong Technique In Product Usage Process2.7%1,749
12
Malaise2.5%1,619
13
Dizziness2.5%1,616
14
Application Site Erythema2.5%1,613
15
Headache2.4%1,568

These are voluntary reports and do not establish that nicotine caused these reactions.

Report severity

29.4%Serious19,253 reports
11.1%Hospitalizations7,273 reports
3.1%Fatal2,037 reports

Seriousness is determined by the reporter, not by OpenClaim.

Nicotine drug interactions

Other drugs that appear in adverse event reports alongside nicotine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Buprenorphine2.2%1,450
2
Acetaminophen2.1%1,392
3
Alprazolam1.6%1,077
4
Pantoprazole-sodium1.6%1,024
5
Pregabalin1.5%1,005
6
Adalimumab1.5%992
7
Diphenhydramine1.5%959
8
Atorvastatin-calcium1.5%957
9
Fluticasone1.4%935
10
Naloxone-hydrochloride1.4%930
11
Prednisone1.4%920
12
Morphine-sulfate1.4%916
13
Amoxicillin1.4%902
14
Budesonide1.3%881
15
Metronidazole1.3%871

Taken alongside

1
Acetaminophen5.5%3,579
2
Albuterol4.7%3,080
3
Aspirin4.0%2,586
4
Atorvastatin-calcium3.0%1,964
5
Gabapentin2.9%1,871
6
Omeprazole2.7%1,761
7
Lisinopril2.5%1,616
8
Fluticasone2.4%1,541
9
Ergocalciferol2.3%1,536
10
Oxycodone2.3%1,525
11
Pantoprazole-sodium2.2%1,407
12
Furosemide2.1%1,395
13
Amlodipine2.1%1,370
14
Ibuprofen2.0%1,333
15
Metoprolol2.0%1,333

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports nicotine side effects

52.4% of nicotine adverse event reports involve female patients and 33.3% involve male patients. The largest age group is adult at 76%. These figures reflect who reports side effects, not underlying risk.

Sex

Female52.4%
Male33.3%
Unknown14.2%

Age group

< 21.4%
2–110.2%
12–170.5%
18–6476.0%
65+21.9%

What is nicotine used for

Conditions and purposes for which patients were taking nicotine when the adverse event was reported.

Accidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAcute Myocardial InfarctionAdverse EventAggressionAgitationAmnesiaAnosmiaAnxietyAppetite DisorderAstheniaAsthmaAtonic Seizures

Showing 15 of 309 indications

Nicotine brand names and reporting trend

Nicotine is sold under brand names including Nicoderm Cq, Nicorette.

Brand names

Nicoderm Cq23,495
Nicorette7,536

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking nicotine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.