Acetylcysteine and Cholestasis - a phase IV clinical study of FDA data

Summary:

Cholestasis is reported as a side effect among people who take Acetylcysteine (acetylcysteine), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Eliquis, and have High blood pressure.

The phase IV clinical study analyzes which people have Cholestasis when taking Acetylcysteine. It is created by eHealthMe based on reports of 11,475 people who have side effects when taking Acetylcysteine from the FDA, and is updated regularly.

What is Acetylcysteine?

Acetylcysteine has active ingredients of acetylcysteine. It is often used in cough. eHealthMe is studying from 11,563 Acetylcysteine users. Check the latest studies of Acetylcysteine.

What is Cholestasis?

Cholestasis (a condition where bile cannot flow from the liver to the duodenum) is found to be associated with 1,032 drugs and 1,815 conditions by eHealthMe. Check the latest studies of Cholestasis.

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

11,475 people reported to have side effects when taking Acetylcysteine.
Among them, 63 people (0.55%) have Cholestasis.

Could Acetylcysteine cause Cholestasis?

Among these 63 people:

How long have people been on Acetylcysteine when they have Cholestasis? *

  • < 1 month: 100 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Cholestasis when taking Acetylcysteine? *

  • female: 43.1 %
  • male: 56.9 %

What is the age of people who have Cholestasis when taking Acetylcysteine? *

  • 0-1: 0.0 %
  • 2-9: 1.85 %
  • 10-19: 5.56 %
  • 20-29: 0.0 %
  • 30-39: 7.41 %
  • 40-49: 3.7 %
  • 50-59: 7.41 %
  • 60+: 74.07 %

What are other drugs people take besides Acetylcysteine? *

  1. Eliquis: 18 people, 28.57%
  2. Amlodipine: 13 people, 20.63%
  3. Idebenone: 7 people, 11.11%
  4. Aspirin: 6 people, 9.52%
  5. Acetaminophen: 6 people, 9.52%
  6. Heparin: 4 people, 6.35%
  7. Dilaudid: 3 people, 4.76%
  8. Prednisolone: 3 people, 4.76%
  9. Lasix: 3 people, 4.76%
  10. Heparin Sodium: 3 people, 4.76%

What are other side effects people have besides Cholestasis? *

  1. Cell Death: 19 people, 30.16%
  2. Jaundice - Yellow Skin (a yellowish pigmentation of the skin): 17 people, 26.98%
  3. General Physical Health Deterioration (weak health status): 8 people, 12.70%
  4. Hepatitis (inflammation of the liver): 8 people, 12.70%
  5. Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 8 people, 12.70%
  6. Fatigue (feeling of tiredness): 8 people, 12.70%
  7. Thrombocytopenia (decrease of platelets in blood): 8 people, 12.70%
  8. Activated Partial Thromboplastin Time Prolonged: 8 people, 12.70%
  9. Nausea And Vomiting: 8 people, 12.70%
  10. Hepatic Encephalopathy (spectrum of neuropsychiatric abnormalities in patients with liver failure): 7 people, 11.11%

What are the existing conditions these people have? *

  1. High Blood Pressure: 21 people, 33.33%
  2. Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 18 people, 28.57%
  3. Constipation: 17 people, 26.98%
  4. Iron Deficiency Anaemia: 16 people, 25.40%
  5. Atrial Fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles): 16 people, 25.40%
  6. Stroke (sudden death of a portion of the brain cells due to a lack of oxygen): 16 people, 25.40%
  7. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 16 people, 25.40%
  8. Pain: 16 people, 25.40%
  9. Anaemia (lack of blood): 15 people, 23.81%
  10. Urinary Retention (the inability to completely or partially empty the bladder): 15 people, 23.81%

* Approximation only. Some reports may have incomplete information.

Do you take Acetylcysteine and have Cholestasis?

- Check whether Cholestasis 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 Acetylcysteine:

Cholestasis treatments and more:

How severe was Cholestasis and when was it recovered:

Expand to all the drugs that have ingredients of acetylcysteine:

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 Acetylcysteine:

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 Cholestasis:

Browse all the conditions that are associated with Cholestasis:


How the study uses the data?

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