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Profen and Injection site necrosis - a phase IV clinical study of FDA data

Summary:

Injection site necrosis is reported as a side effect among people who take Profen (ibuprofen), especially for people who are female, 50-59 old, also take Copaxone, and have Multiple sclerosis.

The phase IV clinical study analyzes which people have Injection site necrosis 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 245,311 Profen users. Check the latest studies of Profen.

What is Injection site necrosis?

Injection site necrosis (death of body tissue at injection site) is found to be associated with 136 drugs and 314 conditions by eHealthMe. Check the latest studies of Injection site necrosis.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.

On Aug, 30, 2026

239,319 people reported to have side effects when taking Profen.
Among them, 44 people (0.02%) have Injection site necrosis.

Could Profen cause Injection site necrosis?

Among these 44 people:

What is the gender of people who have Injection site necrosis when taking Profen? *

  • female: 62.79 %
  • male: 37.21 %

What is the age of people who have Injection site necrosis when taking Profen? *

  • 0-1: 0.0 %
  • 2-9: 2.56 %
  • 10-19: 0.0 %
  • 20-29: 15.38 %
  • 30-39: 2.56 %
  • 40-49: 17.95 %
  • 50-59: 56.41 %
  • 60+: 5.13 %

What are other drugs people take besides Profen? *

  1. Copaxone: 10 people, 22.73%
  2. Rebif: 8 people, 18.18%
  3. Betaseron: 6 people, 13.64%
  4. Flonase: 3 people, 6.82%
  5. Premarin: 3 people, 6.82%
  6. Gabapentin: 3 people, 6.82%
  7. Sotradecol: 3 people, 6.82%
  8. Hydrochlorothiazide: 3 people, 6.82%
  9. Provera: 3 people, 6.82%
  10. Zoloft: 3 people, 6.82%

What are other side effects people have besides Injection site necrosis? *

  1. Injection Site Pain: 9 people, 20.45%
  2. Injection Site Reaction: 8 people, 18.18%
  3. Vasculitis (inflammation of a blood vessel or blood vessels): 8 people, 18.18%
  4. Rashes (redness): 6 people, 13.64%
  5. Scar: 5 people, 11.36%
  6. Injection Site Induration: 5 people, 11.36%
  7. Injection Site Erythema (redness at injection site): 5 people, 11.36%
  8. Panniculitis (inflammation of the subcutaneous fat): 5 people, 11.36%
  9. Injection Site Cellulitis (injection site inflammation): 5 people, 11.36%
  10. Injection Site Haemorrhage (bleeding from injection site): 5 people, 11.36%

What are the existing conditions these people have? *

  1. Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 17 people, 38.64%
  2. 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): 2 people, 4.55%
  3. Fever: 2 people, 4.55%
  4. Alcoholism (problems with alcohol): 2 people, 4.55%
  5. Renal Colic (renal pain): 1 person, 2.27%
  6. Secondary Progressive Multiple Sclerosis (a stage of ms which comes after relapsing remitting ms in many cases): 1 person, 2.27%
  7. Prostate Cancer: 1 person, 2.27%
  8. Parkinson's Disease: 1 person, 2.27%
  9. Neuralgia (pain in one or more nerves): 1 person, 2.27%
  10. The Flu (the flu is caused by an influenza virus): 1 person, 2.27%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Injection site necrosis?

- Check whether Injection site necrosis is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously

Related studies:

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

Injection site necrosis treatments and more:

How severe was Injection site necrosis 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+

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

Browse all the drugs that are associated with Injection site necrosis:

Browse all the conditions that are associated with Injection site necrosis:

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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