Elmiron and Head injury - a phase IV clinical study of FDA data


We study 8,870 people who have side effects when taking Elmiron. Head injury is found, especially among people who are female, 60+ old, have been taking the drug for 10+ years, also take Eliquis and have Gastroesophageal reflux disease.

The phase IV clinical study analyzes which people take Elmiron and have Head injury. 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, 25, 2023

8,870 people reported to have side effects when taking Elmiron.
Among them, 31 people (0.35%) have Head injury.

What is Elmiron?

Elmiron has active ingredients of pentosan polysulfate sodium. It is used in interstitial cystitis (ic). Currently, eHealthMe is studying from 9,155 Elmiron users.

What is Head injury?

Head injury is found to be associated with 3,825 drugs and 3,158 conditions by eHealthMe. Currently, we are studying 151,201 people who have Head injury.

Number of Elmiron and Head injury reports submitted per year:

Could Elmiron cause Head injury?

Time on Elmiron when people have Head injury *:

  • < 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: 0.0 %
  • 10+ years: 100 %

Gender of people who have Head injury when taking Elmiron *:

  • female: 93.33 %
  • male: 6.67 %

Age of people who have Head injury when taking Elmiron *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 8.7 %
  • 30-39: 8.7 %
  • 40-49: 26.09 %
  • 50-59: 13.04 %
  • 60+: 43.48 %

Common drugs people take besides Elmiron *:

  1. Eliquis: 5 people, 16.13%
  2. Wellbutrin: 3 people, 9.68%
  3. Lyrica: 2 people, 6.45%
  4. Lanoxin: 2 people, 6.45%
  5. Praluent: 2 people, 6.45%
  6. Promethazine: 2 people, 6.45%
  7. Plavix: 2 people, 6.45%
  8. Humira: 2 people, 6.45%
  9. Synthroid: 2 people, 6.45%
  10. Hydrocodone: 2 people, 6.45%

Common side effects people have besides Head injury *:

  1. Pain: 7 people, 22.58%
  2. Chest Pain: 6 people, 19.35%
  3. Drug Ineffective: 6 people, 19.35%
  4. Diarrhea: 5 people, 16.13%
  5. Back Pain: 5 people, 16.13%
  6. Nervous System Disorder (a general class of medical conditions affecting the nervous system): 4 people, 12.90%
  7. Insomnia (sleeplessness): 4 people, 12.90%
  8. Pain In Extremity: 4 people, 12.90%
  9. Dizziness: 4 people, 12.90%
  10. Confusional State: 4 people, 12.90%

Common conditions people have *:

  1. Stress And Anxiety: 5 people, 16.13%
  2. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 5 people, 16.13%
  3. Nausea (feeling of having an urge to vomit): 4 people, 12.90%
  4. Migraine (headache): 4 people, 12.90%
  5. Stroke (sudden death of a portion of the brain cells due to a lack of oxygen): 3 people, 9.68%
  6. Atrial Fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles): 3 people, 9.68%
  7. Bladder Disorder: 3 people, 9.68%
  8. Bladder Pain: 3 people, 9.68%
  9. Depression: 3 people, 9.68%
  10. Fibromyalgia (a long-term condition which causes pain all over the body): 3 people, 9.68%

* Approximation only. Some reports may have incomplete information.

Do you take Elmiron and have Head injury?

Check whether Head injury 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

How severe was Head injury and when was it recovered:

Expand to all the drugs that have ingredients of pentosan polysulfate sodium:

Alternative drugs to, pros and cons of Elmiron:

Browse all side effects of Elmiron:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Head injury treatments and more:

Common drugs associated with Head injury:

All the drugs that are associated with Head injury:

Common conditions associated with Head injury:

All the conditions that are associated with Head injury:

How the study uses the data?

The study uses data from the FDA. It is based on pentosan polysulfate sodium (the active ingredients of Elmiron) and Elmiron (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 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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