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

Summary:

Mania is reported as a side effect among people who take Aleve (naproxen sodium), especially for people who are male, 50-59 old, also take Lamictal, and have Narcolepsy.

The phase IV clinical study analyzes which people have Mania when taking Aleve. It is created by eHealthMe based on reports of 68,206 people who have side effects when taking Aleve from the FDA, and is updated regularly.

What is Aleve?

Aleve has active ingredients of naproxen sodium. It is often used in pain. eHealthMe is studying from 70,279 Aleve users. Check the latest studies of Aleve.

What is Mania?

Mania (a state of abnormally elevated or irritable mood) is found to be associated with 923 drugs and 1,157 conditions by eHealthMe. Check the latest studies of Mania.

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 Sep, 02, 2026

68,206 people reported to have side effects when taking Aleve.
Among them, 27 people (0.04%) have Mania.

Could Aleve cause Mania?

Among these 27 people:

What is the gender of people who have Mania when taking Aleve? *

  • female: 37.04 %
  • male: 62.96 %

What is the age of people who have Mania when taking Aleve? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 5 %
  • 20-29: 10 %
  • 30-39: 25 %
  • 40-49: 0.0 %
  • 50-59: 40 %
  • 60+: 20 %

What are other drugs people take besides Aleve? *

  1. Lamictal: 13 people, 48.15%
  2. Xyrem: 10 people, 37.04%
  3. Abilify: 9 people, 33.33%
  4. Benadryl: 7 people, 25.93%
  5. Metrogel: 7 people, 25.93%
  6. Lipitor: 6 people, 22.22%
  7. Ritalin: 6 people, 22.22%
  8. Prozac: 6 people, 22.22%
  9. Biotin: 6 people, 22.22%
  10. Augmentin: 6 people, 22.22%

What are other side effects people have besides Mania? *

  1. Stress And Anxiety: 8 people, 29.63%
  2. Sciatica (a set of symptoms including pain caused by general compression or irritation of one of five spinal nerve roots of each sciatic nerve): 6 people, 22.22%
  3. Scoliosis (a medical condition in which a person's spine is curved from side to side): 6 people, 22.22%
  4. Depression: 6 people, 22.22%
  5. Intervertebral Disc Degeneration (spinal disc degeneration): 6 people, 22.22%
  6. Procedural Pain: 6 people, 22.22%
  7. Fatigue (feeling of tiredness): 6 people, 22.22%
  8. Osteoarthritis (a joint disease caused by cartilage loss in a joint): 6 people, 22.22%
  9. Aggression: 5 people, 18.52%
  10. Spinal Stenosis (narrowing of spinal column): 5 people, 18.52%

What are the existing conditions these people have? *

  1. Cataplexy (loss of muscle tone accompanied by full conscious awareness): 11 people, 40.74%
  2. Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 11 people, 40.74%
  3. High Blood Pressure: 10 people, 37.04%
  4. Bipolar Disorder (mood disorder): 10 people, 37.04%
  5. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 9 people, 33.33%
  6. High Blood Cholesterol: 7 people, 25.93%
  7. Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 6 people, 22.22%
  8. Itching: 4 people, 14.81%
  9. Depression: 4 people, 14.81%
  10. Fibromyalgia (a long-term condition which causes pain all over the body): 3 people, 11.11%

* Approximation only. Some reports may have incomplete information.

Do you take Aleve and have Mania?

- Check whether Mania 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 Aleve:

Mania treatments and more:

How severe was Mania and when was it recovered:

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

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 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

Browse all the drugs that are associated with Mania:

Browse all the conditions that are associated with Mania:

  • Mania (1,157 conditions)

Related publications that referenced our studies

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.

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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