Prograf and Polyhydramnios - a phase IV clinical study of FDA data

Summary:

Polyhydramnios is reported as a side effect among people who take Prograf (tacrolimus), especially for people who are 30-39 old, have been taking the drug for 6 - 12 months also take Adalat, and have Renovascular hypertension.

The phase IV clinical study analyzes which people have Polyhydramnios when taking Prograf. It is created by eHealthMe based on reports of 41,725 people who have side effects when taking Prograf from the FDA, and is updated regularly.

What is Prograf?

Prograf has active ingredients of tacrolimus. It is often used in kidney transplant. eHealthMe is studying from 42,230 Prograf users. Check the latest studies of Prograf.

What is Polyhydramnios?

Polyhydramnios (excess of amniotic fluid in the amniotic sac) is found to be associated with 141 drugs and 303 conditions by eHealthMe. Check the latest studies of Polyhydramnios.

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, 01, 2026

41,725 people reported to have side effects when taking Prograf.
Among them, 45 people (0.11%) have Polyhydramnios.

Could Prograf cause Polyhydramnios?

Among these 45 people:

How long have people been on Prograf when they have Polyhydramnios? *

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 65.22 %
  • 1 - 2 years: 4.35 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 30.43 %
  • 10+ years: 0.0 %

What is the age of people who have Polyhydramnios when taking Prograf? *

  • 0-1: 48.28 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 3.45 %
  • 30-39: 48.28 %
  • 40-49: 0.0 %
  • 50-59: 0.0 %
  • 60+: 0.0 %

What are other drugs people take besides Prograf? *

  1. Adalat: 26 people, 57.78%
  2. Amlodipine: 22 people, 48.89%
  3. Trandate: 9 people, 20.00%
  4. Valcyte: 5 people, 11.11%
  5. Celexa: 5 people, 11.11%
  6. Dapsone: 5 people, 11.11%
  7. Vitamin B12: 5 people, 11.11%
  8. Myfortic: 5 people, 11.11%
  9. Cellcept: 3 people, 6.67%
  10. Prednisolone: 3 people, 6.67%

What are other side effects people have besides Polyhydramnios? *

  1. Hydrops Foetalis (fetus characterized by an accumulation of fluid): 14 people, 31.11%
  2. Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 13 people, 28.89%
  3. Cervical Incompetence (serious pregnancy complication in which the cervix starts to open): 12 people, 26.67%
  4. Neonatal Respiratory Failure (a life-threatening condition in which respiratory function is inadequate to maintain the body's need for oxygen supply and carbon dioxide removal while at rest): 11 people, 24.44%
  5. Premature Labor: 9 people, 20.00%
  6. Premature Delivery: 9 people, 20.00%
  7. Premature Baby: 8 people, 17.78%
  8. Maternal Exposure During Pregnancy (use of substance during pregnancy): 7 people, 15.56%
  9. Drug Exposure During Pregnancy: 5 people, 11.11%
  10. Low Birth Weight Baby: 3 people, 6.67%

What are the existing conditions these people have? *

  1. Renovascular Hypertension (a syndrome which consists of high blood pressure caused by the kidneys hormonal response): 25 people, 55.56%
  2. Tocolysis (inhibition of uterine contractions): 24 people, 53.33%
  3. Maternal Therapy To Enhance Foetal Lung Maturity: 24 people, 53.33%
  4. Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 24 people, 53.33%
  5. High Blood Pressure: 8 people, 17.78%
  6. Renal Impairment (severely reduced kidney function): 1 person, 2.22%
  7. Renal Disorder (kidney disease): 1 person, 2.22%
  8. Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 1 person, 2.22%
  9. Epstein-Barr Virus Infection: 1 person, 2.22%
  10. Cytomegalovirus Enterocolitis (virus infection of intestine and colon): 1 person, 2.22%

* Approximation only. Some reports may have incomplete information.

Do you take Prograf and have Polyhydramnios?

- Check whether Polyhydramnios 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 Prograf:

Polyhydramnios treatments and more:

How severe was Polyhydramnios and when was it recovered:

Expand to all the drugs that have ingredients of tacrolimus:

Sub-studies by age:

0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Prograf:

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 Polyhydramnios:

Browse all the conditions that are associated with Polyhydramnios:


How the study uses the data?

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