Nerlynx and Insomnia - a phase IV clinical study of FDA data


We study 1,689 people who have side effects when taking Nerlynx. Insomnia is found, especially among people who are female, , have been taking the drug for 1 - 6 months, also take Imodium and have Breast cancer female.

The phase IV clinical study analyzes which people take Nerlynx and have Insomnia. It is created by eHealthMe based on reports from the FDA, and is updated regularly. You may 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 700+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Sep, 26, 2023

1,689 people reported to have side effects when taking Nerlynx.
Among them, 19 people (1.12%) have Insomnia.

What is Nerlynx?

Nerlynx has active ingredients of neratinib maleate. Currently, eHealthMe is studying from 1,578 Nerlynx users.

What is Insomnia?

Insomnia (sleeplessness) is found to be associated with 4,771 drugs and 5,050 conditions by eHealthMe. Currently, we are studying 416,501 people who have Insomnia.

Number of Nerlynx and Insomnia reports submitted per year:

Could Nerlynx cause Insomnia?

Time on Nerlynx when people have Insomnia *:

  • < 1 month: 42.86 %
  • 1 - 6 months: 57.14 %
  • 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 Insomnia when taking Nerlynx *:

  • female: 100 %
  • male: 0.0 %

Common drugs people take besides Nerlynx *:

  1. Imodium: 4 people, 21.05%
  2. Lomotil: 3 people, 15.79%
  3. Vitamin D3: 2 people, 10.53%
  4. Zofran: 1 person, 5.26%
  5. Lortab: 1 person, 5.26%
  6. Clarinex: 1 person, 5.26%
  7. Effexor: 1 person, 5.26%
  8. Escitalopram: 1 person, 5.26%
  9. Lexapro: 1 person, 5.26%
  10. Lisinopril And Hydrochlorothiazide: 1 person, 5.26%

Common side effects people have besides Insomnia *:

  1. Diarrhea: 17 people, 89.47%
  2. Fatigue (feeling of tiredness): 10 people, 52.63%
  3. Constipation: 8 people, 42.11%
  4. Stress And Anxiety: 6 people, 31.58%
  5. Nausea (feeling of having an urge to vomit): 6 people, 31.58%
  6. Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 5 people, 26.32%
  7. Dry Skin: 5 people, 26.32%
  8. Abdominal Discomfort: 4 people, 21.05%
  9. Drowsiness: 4 people, 21.05%
  10. Nausea And Vomiting: 3 people, 15.79%

Common conditions people have *:

  1. Breast Cancer Female: 7 people, 36.84%
  2. Breast Cancer: 6 people, 31.58%
  3. Ovarian Cancer (cancer of ovary): 1 person, 5.26%
  4. Muscle Spasms (muscle contraction): 1 person, 5.26%
  5. Lung Neoplasm Malignant (cancer tumour of lung): 1 person, 5.26%
  6. Diarrhea: 1 person, 5.26%
  7. Clostridium Difficile Colitis (inflammation of colon by clostridium difficile bacteria infection): 1 person, 5.26%
  8. Breast Cancer Metastatic: 1 person, 5.26%
  9. Breast Cancer In Situ: 1 person, 5.26%

* Approximation only. Some reports may have incomplete information.

Do you take Nerlynx and have Insomnia?

Check whether Insomnia 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 studies

Nerlynx side effects by duration, gender and age:

Insomnia treatments and more:

Common drugs associated with Insomnia:

All the drugs that are associated with Insomnia:

Common conditions associated with Insomnia:

All the conditions that are associated with Insomnia:

How the study uses the data?

The study uses data from the FDA. It is based on neratinib maleate (the active ingredients of Nerlynx) and Nerlynx (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 700+ 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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