Promethazine and Psychiatric symptom - a phase IV clinical study of FDA data

Summary:

Psychiatric symptom is reported as a side effect among people who take Promethazine (promethazine hydrochloride), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Zimovane, and have Insomnia.

The phase IV clinical study analyzes which people have Psychiatric symptom when taking Promethazine. It is created by eHealthMe based on reports of 31,259 people who have side effects when taking Promethazine from the FDA, and is updated regularly.

What is Promethazine?

Promethazine has active ingredients of promethazine hydrochloride. It is often used in nausea. eHealthMe is studying from 32,300 Promethazine users. Check the latest studies of Promethazine.

What is Psychiatric symptom?

Psychiatric symptom is found to be associated with 639 drugs and 755 conditions by eHealthMe. Check the latest studies of Psychiatric symptom.



On Jul, 07, 2026

31,259 people reported to have side effects when taking Promethazine.
Among them, 37 people (0.12%) have Psychiatric symptom.

Could Promethazine cause Psychiatric symptom?

Among these 37 people:

How long have people been on Promethazine when they have Psychiatric symptom? *

  • < 1 month: 66.67 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 33.33 %
  • 10+ years: 0.0 %

What is the gender of people who have Psychiatric symptom when taking Promethazine? *

  • female: 94.12 %
  • male: 5.88 %

What is the age of people who have Psychiatric symptom when taking Promethazine? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 3.33 %
  • 30-39: 0.0 %
  • 40-49: 3.33 %
  • 50-59: 0.0 %
  • 60+: 93.33 %

What are other drugs people take besides Promethazine? *

  1. Zimovane: 13 people, 35.14%
  2. Zopiclone: 9 people, 24.32%
  3. Melatonin: 9 people, 24.32%
  4. Xanax: 9 people, 24.32%
  5. Paxil: 6 people, 16.22%
  6. Effexor: 6 people, 16.22%
  7. Clonazepam: 5 people, 13.51%
  8. Cymbalta: 5 people, 13.51%
  9. Phenergan: 4 people, 10.81%
  10. Pantoprazole: 4 people, 10.81%

What are other side effects people have besides Psychiatric symptom? *

  1. Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 25 people, 67.57%
  2. Malaise (a feeling of general discomfort or uneasiness): 24 people, 64.86%
  3. Agitation (state of anxiety or nervous excitement): 22 people, 59.46%
  4. Nightmares (unpleasant dreams): 22 people, 59.46%
  5. Confusional State: 22 people, 59.46%
  6. Disturbance In Attention: 19 people, 51.35%
  7. Headache (pain in head): 17 people, 45.95%
  8. Fatigue (feeling of tiredness): 15 people, 40.54%
  9. Dizziness: 15 people, 40.54%
  10. Confusion: 14 people, 37.84%

What are the existing conditions these people have? *

  1. Tearfulness (excess tearing): 9 people, 24.32%
  2. Insomnia (sleeplessness): 9 people, 24.32%
  3. Emotional Distress: 8 people, 21.62%
  4. High Blood Pressure: 7 people, 18.92%
  5. Cardiac Disorder: 7 people, 18.92%
  6. Rashes (redness): 5 people, 13.51%
  7. Pain: 3 people, 8.11%
  8. Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 2 people, 5.41%
  9. Primary Myelofibrosis (primary disorder of the bone marrow): 2 people, 5.41%
  10. Sinusitis (inflammation of sinus): 1 person, 2.70%

* Approximation only. Some reports may have incomplete information.

Do you take Promethazine and have Psychiatric symptom?

- Check whether Psychiatric symptom is associated with a drug or a condition
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Related studies:

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

Psychiatric symptom treatments and more:

How severe was Psychiatric symptom and when was it recovered:

Expand to all the drugs that have ingredients of promethazine hydrochloride:

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 Promethazine:

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 Psychiatric symptom:

Browse all the conditions that are associated with Psychiatric symptom:

Related publications that referenced our studies


How the study uses the data?

The study uses data from the FDA. It is based on promethazine hydrochloride (the active ingredients of Promethazine) and Promethazine (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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