Diclofenac and Sudden cardiac death - a phase IV clinical study of FDA data


Sudden cardiac death is found among people who take Diclofenac, especially for people who are male, 40-49 old, have been taking the drug for 5 - 10 years.

The phase IV clinical study is created by eHealthMe based on reports of 36,069 people who have side effects when taking Diclofenac 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 Sep, 11, 2023

36,069 people reported to have side effects when taking Diclofenac.
Among them, 34 people (0.09%) died.

What is Diclofenac?

Diclofenac has active ingredients of diclofenac. eHealthMe is studying from 30,073 Diclofenac users for its effectiveness, alternative drugs and more.

Number of Diclofenac and Sudden cardiac death reports submitted per year:

Could Diclofenac cause Sudden cardiac death?

Time on Diclofenac when people died *:

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

Gender of people who died when taking Diclofenac *:

  • female: 0.0 %
  • male: 100 %

Age of people who died when taking Diclofenac *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 100 %
  • 50-59: 0.0 %
  • 60+: 0.0 %

Common drugs people take besides Diclofenac *:

  1. Abilify: 25 people, 73.53%
  2. Zolpidem: 23 people, 67.65%
  3. Mirtazapine: 10 people, 29.41%
  4. Duloxetine Hydrochloride: 10 people, 29.41%
  5. Gabapentin: 10 people, 29.41%
  6. Ramipril: 10 people, 29.41%
  7. Tramadol Hydrochloride: 9 people, 26.47%
  8. Trazodone Hydrochloride: 8 people, 23.53%
  9. Aripiprazole: 5 people, 14.71%
  10. Remeron: 5 people, 14.71%

Common side effects people have before they died *:

  1. Sleep Disorder: 33 people, 97.06%
  2. Pulmonary Congestion (congestion in the lungs): 33 people, 97.06%
  3. Oropharyngeal Pain: 33 people, 97.06%
  4. Nausea And Vomiting: 33 people, 97.06%
  5. Nausea (feeling of having an urge to vomit): 33 people, 97.06%
  6. Electrocardiogram Qt Prolonged: 33 people, 97.06%
  7. Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 33 people, 97.06%
  8. Antidepressant Drug Level Above Therapeutic: 33 people, 97.06%
  9. Analgesic Drug Level Above Therapeutic: 33 people, 97.06%
  10. Arrhythmias (irregular heartbeat): 5 people, 14.71%

Common conditions people have *:

  1. Pain: 1 person, 2.94%
  2. Infection: 1 person, 2.94%
  3. Hyperlipidaemia (presence of excess lipids in the blood): 1 person, 2.94%
  4. High Blood Pressure: 1 person, 2.94%
  5. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 1 person, 2.94%
  6. Blood Uric Acid Abnormal: 1 person, 2.94%

* Approximation only. Some reports may have incomplete information.

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

Expand to all the drugs that have ingredients of diclofenac:

Alternative drugs to, pros and cons of Diclofenac:

Common Diclofenac side effects:

Browse all side effects of Diclofenac:

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COVID vaccines that are related to Sudden cardiac death:

Common drugs associated with Sudden cardiac death:

All the drugs that are associated with Sudden cardiac death:

Common conditions associated with Sudden cardiac death:

All the conditions that are associated with Sudden cardiac death:

How the study uses the data?

The study uses data from the FDA. It is based on diclofenac (the active ingredients of Diclofenac) and Diclofenac (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 eHealthMe.com 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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