Profen and Sleeping difficulty - a phase IV clinical study of FDA data

Summary:

Sleeping difficulty is reported as a side effect among people who take Profen (ibuprofen), especially for people who are female, 40-49 old, have been taking the drug for < 1 month also take Enbrel, and have Rheumatoid arthritis.

The phase IV clinical study analyzes which people have Sleeping difficulty when taking Profen. It is created by eHealthMe based on reports of 239,319 people who have side effects when taking Profen from the FDA, and is updated regularly.

What is Profen?

Profen has active ingredients of ibuprofen. It is often used in pain. eHealthMe is studying from 245,301 Profen users. Check the latest studies of Profen.

What is Sleeping difficulty?

Sleeping difficulty (difficult sleeping) is found to be associated with 4,213 drugs and 5,350 conditions by eHealthMe. Check the latest studies of Sleeping difficulty.



On Oct, 11, 2025

239,319 people reported to have side effects when taking Profen.
Among them, 7,113 people (2.97%) have Sleeping difficulty.

Could Profen cause Sleeping difficulty?

Among these 7,113 people:

How long have people been on Profen when they have Sleeping difficulty? *

  • < 1 month: 63.35 %
  • 1 - 6 months: 14.03 %
  • 6 - 12 months: 2.26 %
  • 1 - 2 years: 2.26 %
  • 2 - 5 years: 10.41 %
  • 5 - 10 years: 2.71 %
  • 10+ years: 4.98 %

What is the gender of people who have Sleeping difficulty when taking Profen? *

  • female: 73.19 %
  • male: 26.81 %

What is the age of people who have Sleeping difficulty when taking Profen? *

  • 0-1: 0.72 %
  • 2-9: 0.59 %
  • 10-19: 1.92 %
  • 20-29: 5.63 %
  • 30-39: 9.87 %
  • 40-49: 38.36 %
  • 50-59: 21.61 %
  • 60+: 21.3 %

What are other drugs people take besides Profen? *

  1. Enbrel: 1,774 people, 24.94%
  2. Simponi: 1,725 people, 24.25%
  3. Cimzia: 1,699 people, 23.89%
  4. Actemra: 1,670 people, 23.48%
  5. Tylenol: 1,654 people, 23.25%
  6. Arava: 1,624 people, 22.83%
  7. Orencia: 1,620 people, 22.78%
  8. Pantoprazole: 1,617 people, 22.73%
  9. Zopiclone: 1,340 people, 18.84%
  10. Oxycodone: 1,335 people, 18.77%

What are other side effects people have besides Sleeping difficulty? *

  1. Fatigue (feeling of tiredness): 2,648 people, 37.23%
  2. Headache (pain in head): 2,562 people, 36.02%
  3. Rashes (redness): 2,267 people, 31.87%
  4. Weakness: 2,096 people, 29.47%
  5. Diarrhea: 2,028 people, 28.51%
  6. Joint Pain: 1,955 people, 27.48%
  7. Nausea (feeling of having an urge to vomit): 1,775 people, 24.95%
  8. Joint Swelling: 1,773 people, 24.93%
  9. Itching: 1,723 people, 24.22%
  10. Peripheral Swelling: 1,640 people, 23.06%

What are the existing conditions these people have? *

  1. Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 1,958 people, 27.53%
  2. Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 508 people, 7.14%
  3. Depression: 486 people, 6.83%
  4. Stress And Anxiety: 381 people, 5.36%
  5. Psoriasis (immune-mediated disease that affects the skin): 357 people, 5.02%
  6. Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 334 people, 4.70%
  7. High Blood Pressure: 293 people, 4.12%
  8. Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 227 people, 3.19%
  9. Relapsing-Remitting Multiple Sclerosis (reoccurrence of an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 201 people, 2.83%
  10. Fibromyalgia (a long-term condition which causes pain all over the body): 196 people, 2.76%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Sleeping difficulty?

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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Profen:

Sleeping difficulty treatments and more:

How severe was Sleeping difficulty and when was it recovered:

Expand to all the drugs that have ingredients of ibuprofen:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Common Profen side effects:

Browse all side effects of Profen:

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

Common drugs associated with Sleeping difficulty:

Browse all the drugs that are associated with Sleeping difficulty:

Common conditions associated with Sleeping difficulty:

Browse all the conditions that are associated with Sleeping difficulty:

Drugs similar to Profen and Sleeping difficulty :

Related publications that referenced our studies


How the study uses the data?

The study uses data from the FDA. It is based on ibuprofen (the active ingredients of Profen) and Profen (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.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML 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 800+ peer-reviewed 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, DISCLAIMER, USE FOR PUBLICATION

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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