Nicorette and Anaphylaxis - a phase IV clinical study of FDA data


Anaphylaxis is found among people who take Nicorette, especially for people who are female, 40-49 old, have been taking the drug for < 1 month.

The phase IV clinical study analyzes which people take Nicorette and have Anaphylaxis. It is created by eHealthMe based on reports of 17,770 people who have side effects when taking Nicorette from the FDA, and is updated regularly. You can use the study as a second opinion to make health care decisions.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Mar, 24, 2023

17,770 people reported to have side effects when taking Nicorette.
Among them, 27 people (0.15%) have Anaphylaxis.

What is Nicorette?

Nicorette has active ingredients of nicotine polacrilex. It is often used in quit smoking. eHealthMe is studying from 17,914 Nicorette users for its effectiveness, alternative drugs and more.

What is Anaphylaxis?

Anaphylaxis (serious allergic reaction that is rapid in onset and may cause death) is found to be associated with 3,288 drugs and 2,678 conditions by eHealthMe.

Number of Nicorette and Anaphylaxis reports submitted per year:

Could Nicorette cause Anaphylaxis?

Time on Nicorette when people have Anaphylaxis *:

  • < 1 month: 100 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Anaphylaxis when taking Nicorette *:

  • female: 65.38 %
  • male: 34.62 %

Age of people who have Anaphylaxis when taking Nicorette *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 5 %
  • 20-29: 5 %
  • 30-39: 25 %
  • 40-49: 30 %
  • 50-59: 20 %
  • 60+: 15 %

Common drugs people take besides Nicorette *:

  1. Paracetamol: 3 people, 11.11%
  2. Nicotine: 2 people, 7.41%
  3. Fluoxetine: 2 people, 7.41%
  4. Rivaroxaban: 1 person, 3.70%
  5. Pantoprazole: 1 person, 3.70%
  6. Ondansetron: 1 person, 3.70%
  7. Effexor: 1 person, 3.70%
  8. Amlodipine: 1 person, 3.70%

Common side effects people have besides Anaphylaxis *:

  1. Breathing Difficulty: 5 people, 18.52%
  2. Swallowing Difficulty: 4 people, 14.81%
  3. Rashes (redness): 4 people, 14.81%
  4. Urticaria (rash of round, red welts on the skin that itch intensely): 4 people, 14.81%
  5. Throat Tightness: 3 people, 11.11%
  6. Nausea (feeling of having an urge to vomit): 2 people, 7.41%
  7. Oral Pain: 2 people, 7.41%
  8. Eyelid Oedema (eyelids are swollen and contain excessive fluid): 2 people, 7.41%
  9. Face Oedema (swelling of face): 2 people, 7.41%
  10. Angioedema (rapid swelling of the dermis): 2 people, 7.41%

Common conditions people have *:

  1. Epilepsy (common and diverse set of chronic neurological disorders characterized by seizures): 1 person, 3.70%

* Approximation only. Some reports may have incomplete information.

Do you take Nicorette and have Anaphylaxis?

Check whether Anaphylaxis is associated with a drug or a condition

How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

Related publications that referenced our studies

Related studies

How severe was Anaphylaxis and when was it recovered:

Expand to all the drugs that have ingredients of nicotine polacrilex:

Alternative drugs to, pros and cons of Nicorette:

Common Nicorette side effects:

Browse all side effects of Nicorette:

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Anaphylaxis treatments and more:

COVID vaccines that are related to Anaphylaxis:

Common drugs associated with Anaphylaxis:

All the drugs that are associated with Anaphylaxis:

Common conditions associated with Anaphylaxis:

All the conditions that are associated with Anaphylaxis:

How the study uses the data?

The study uses data from the FDA. It is based on nicotine polacrilex (the active ingredients of Nicorette) and Nicorette (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

Who is eHealthMe?

With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).


WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.

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