Aleve and Akathisia - a phase IV clinical study of FDA data


Akathisia is reported only by a few people who take Aleve.

The phase IV clinical study analyzes which people take Aleve and have Akathisia. It is created by eHealthMe based on reports of 64,171 people who have side effects while taking Aleve from the FDA, and is updated regularly.

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 Dec, 08, 2022

64,171 people reported to have side effects when taking Aleve.
Among them, 5 people (0.01%) have Akathisia.

What is Aleve?

Aleve has active ingredients of naproxen sodium. It is often used in pain. eHealthMe is studying from 66,186 Aleve users for its effectiveness, alternative drugs and more.

What is Akathisia?

Akathisia (a movement disorder characterized by a feeling of inner restlessness) is found to be associated with 1,231 drugs and 767 conditions by eHealthMe.

Number of Aleve and Akathisia reports submitted per year:

Could Aleve cause Akathisia?

Gender of people who have Akathisia when taking Aleve *:

  • female: 40 %
  • male: 60 %

Age of people who have Akathisia when taking Aleve *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 25 %
  • 50-59: 0.0 %
  • 60+: 75 %

Common drugs people take besides Aleve *:

  1. Percocet: 3 people, 60.00%
  2. Metoclopramide: 2 people, 40.00%
  3. Valtrex: 2 people, 40.00%
  4. Reglan: 2 people, 40.00%
  5. Pantoprazole: 2 people, 40.00%
  6. Oxycodone: 2 people, 40.00%
  7. Skelaxin: 2 people, 40.00%
  8. Fluoxetine: 2 people, 40.00%
  9. Cymbalta: 2 people, 40.00%
  10. Neurontin: 2 people, 40.00%

Common side effects people have besides Akathisia *:

  1. Gait Disturbance: 4 people, 80.00%
  2. Tardive Dyskinesia (a disorder that involves involuntary movements): 4 people, 80.00%
  3. Dyskinesia (abnormality or impairment of voluntary movement): 4 people, 80.00%
  4. Mastication Disorder (disease of chewing food): 3 people, 60.00%
  5. Dry Mouth: 3 people, 60.00%
  6. Dizziness: 3 people, 60.00%
  7. Swallowing Difficulty: 3 people, 60.00%
  8. Injury: 3 people, 60.00%
  9. Depression: 2 people, 40.00%
  10. Pain In Extremity: 2 people, 40.00%

Common conditions people have *:

  1. Stress And Anxiety: 2 people, 40.00%
  2. Thinking Abnormal: 1 person, 20.00%
  3. Tardive Dyskinesia (a disorder that involves involuntary movements): 1 person, 20.00%
  4. Restless Leg Syndrome (a powerful urge to move your legs): 1 person, 20.00%
  5. Radiculopathy (a set of conditions in which one or more nerves is affected and does not work properly): 1 person, 20.00%
  6. Neuropathy Peripheral (surface nerve damage): 1 person, 20.00%
  7. Irritable Bowel Syndrome: 1 person, 20.00%
  8. Insomnia (sleeplessness): 1 person, 20.00%
  9. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 1 person, 20.00%
  10. Fever: 1 person, 20.00%

* Approximation only. Some reports may have incomplete information.

Do you take Aleve and have Akathisia?

Check whether Akathisia 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 publications that referenced our studies

Related studies

How severe was Akathisia and when was it recovered:

Expand to all the drugs that have ingredients of naproxen sodium:

Alternative drugs to, pros and cons of Aleve:

Common Aleve side effects:

Browse all side effects of Aleve:

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

Akathisia treatments and more:

COVID vaccines that are related to Akathisia:

Common drugs associated with Akathisia:

All the drugs that are associated with Akathisia:

Common conditions associated with Akathisia:

All the conditions that are associated with Akathisia:

How the study uses the data?

The study uses data from the FDA. It is based on naproxen sodium (the active ingredients of Aleve) and Aleve (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 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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