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


We study 110,029 people who have side effects when taking Spironolactone. Mania is found, especially among people who are female, 60+ old, have been taking the drug for < 1 month, also take Norfloxacin and have Gastroesophageal reflux disease.

The phase IV clinical study analyzes which people take Spironolactone and have Mania. 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, 28, 2023

110,029 people reported to have side effects when taking Spironolactone.
Among them, 84 people (0.08%) have Mania.

What is Spironolactone?

Spironolactone has active ingredients of spironolactone. It is used in acne. Currently, eHealthMe is studying from 113,624 Spironolactone users.

What is Mania?

Mania (a state of abnormally elevated or irritable mood) is found to be associated with 1,689 drugs and 1,152 conditions by eHealthMe. Currently, we are studying 24,061 people who have Mania.

Number of Spironolactone and Mania reports submitted per year:

Could Spironolactone cause Mania?

Time on Spironolactone when people have Mania *:

  • < 1 month: 50 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 50 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Mania when taking Spironolactone *:

  • female: 53.52 %
  • male: 46.48 %

Age of people who have Mania when taking Spironolactone *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 1.56 %
  • 20-29: 0.0 %
  • 30-39: 14.06 %
  • 40-49: 28.12 %
  • 50-59: 14.06 %
  • 60+: 42.19 %

Common drugs people take besides Spironolactone *:

  1. Norfloxacin: 17 people, 20.24%
  2. Amlodipine: 15 people, 17.86%
  3. Memantine: 11 people, 13.10%
  4. Hydrochlorothiazide: 11 people, 13.10%
  5. Furosemide: 9 people, 10.71%
  6. Allopurinol: 8 people, 9.52%
  7. Tracleer: 6 people, 7.14%
  8. Donepezil: 6 people, 7.14%
  9. Celexa: 6 people, 7.14%
  10. Lansoprazole: 5 people, 5.95%

Common side effects people have besides Mania *:

  1. Insomnia (sleeplessness): 29 people, 34.52%
  2. Obsessive-Compulsive Disorder (an anxiety disorder characterized by intrusive thoughts that produce uneasiness, apprehension, fear, or worry;): 16 people, 19.05%
  3. Agitation (state of anxiety or nervous excitement): 16 people, 19.05%
  4. Psychomotor Hyperactivity (feelings of extreme restlessness): 14 people, 16.67%
  5. Logorrhea: 11 people, 13.10%
  6. Disturbance In Attention: 10 people, 11.90%
  7. Speech Disorder: 10 people, 11.90%
  8. Tachyphrenia (abnormally rapid mental activity): 8 people, 9.52%
  9. Stress And Anxiety: 8 people, 9.52%
  10. Persecutory Delusion: 7 people, 8.33%

Common conditions people have *:

  1. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 19 people, 22.62%
  2. Cirrhosis Alcoholic (chronic disease of the liver marked by degeneration of cells, inflammation, and fibrous thickening of tissue caused by alcoholism): 13 people, 15.48%
  3. Peritonitis (inflammation of the peritoneum, the thin tissue that lines the inner wall of the abdomen and covers most of the abdominal organs): 10 people, 11.90%
  4. Bipolar Disorder (mood disorder): 6 people, 7.14%
  5. Pulmonary Hypertension (increase in blood pressure in the lung artery): 6 people, 7.14%
  6. Cognitive Disorder (mental health disorders affects learning, memory, perception, and problem solving): 6 people, 7.14%
  7. Stress And Anxiety: 5 people, 5.95%
  8. Borderline Personality Disorder: 5 people, 5.95%
  9. Major Depression (a mood state that goes well beyond temporarily feeling sad or blue. it is a serious medical illness that affects one's thoughts, feelings): 3 people, 3.57%
  10. Seborrhea: 3 people, 3.57%

* Approximation only. Some reports may have incomplete information.

Do you take Spironolactone and have Mania?

Check whether Mania 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

Spironolactone side effects by duration, gender and age:

Mania treatments and more:

Common drugs associated with Mania:

All the drugs that are associated with Mania:

Common conditions associated with Mania:

All the conditions that are associated with Mania:

  • Mania (1,152 conditions)

How the study uses the data?

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