Itraconazole and Sedation - a phase IV clinical study of FDA data

Summary:

Sedation is reported as a side effect among people who take Itraconazole (itraconazole), especially for people who are male, 30-39 old, have been taking the drug for < 1 month also take Fluconazole, and have Schizophrenia.

The phase IV clinical study analyzes which people have Sedation when taking Itraconazole. It is created by eHealthMe based on reports of 12,233 people who have side effects when taking Itraconazole from the FDA, and is updated regularly.

What is Itraconazole?

Itraconazole has active ingredients of itraconazole. It is often used in fungal infection. eHealthMe is studying from 12,372 Itraconazole users. Check the latest studies of Itraconazole.

What is Sedation?

Sedation is found to be associated with 1,317 drugs and 1,290 conditions by eHealthMe. Check the latest studies of Sedation.

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 Aug, 31, 2026

12,233 people reported to have side effects when taking Itraconazole.
Among them, 20 people (0.16%) have Sedation.

Could Itraconazole cause Sedation?

Among these 20 people:

How long have people been on Itraconazole when they have Sedation? *

  • < 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 Sedation when taking Itraconazole? *

  • female: 22.22 %
  • male: 77.78 %

What is the age of people who have Sedation when taking Itraconazole? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 20.0 %
  • 30-39: 53.33 %
  • 40-49: 20.0 %
  • 50-59: 0.0 %
  • 60+: 6.67 %

What are other drugs people take besides Itraconazole? *

  1. Fluconazole: 5 people, 25.00%
  2. Cytarabine: 4 people, 20.00%
  3. Clonazepam: 4 people, 20.00%
  4. Acyclovir: 4 people, 20.00%
  5. Mylotarg: 4 people, 20.00%
  6. Clozapine: 4 people, 20.00%
  7. Risperidone: 4 people, 20.00%
  8. Allopurinol: 3 people, 15.00%
  9. Amphotericin B: 3 people, 15.00%
  10. Mesna: 2 people, 10.00%

What are other side effects people have besides Sedation? *

  1. Hepatomegaly (abnormal enlargement of the liver): 5 people, 25.00%
  2. Bronchopulmonary Aspergillosis (lung disorder caused by aspergillus fungi): 5 people, 25.00%
  3. Hepatic Failure (liver failure): 5 people, 25.00%
  4. Hepatic Necrosis (large portions of liver die off due to severe liver disease): 4 people, 20.00%
  5. Liver Function Tests Nos Abnormal: 4 people, 20.00%
  6. Arrhythmias (irregular heartbeat): 4 people, 20.00%
  7. Budd Chiari Syndrome (problem that results from blood clotting in the veins flowing out of the liver (hepatic veins)): 4 people, 20.00%
  8. Caecitis (inflammation of the cecum): 4 people, 20.00%
  9. High Blood Pressure: 4 people, 20.00%
  10. Pancytopenia (medical condition in which there is a reduction in the number of red and white blood cells, as well as platelets): 4 people, 20.00%

What are the existing conditions these people have? *

  1. Schizophrenia (a mental disorder characterized by a breakdown of thought processes): 3 people, 15.00%
  2. Bronchopulmonary Aspergillosis (lung disorder caused by aspergillus fungi): 2 people, 10.00%
  3. Ill-Defined Disorder: 1 person, 5.00%
  4. 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): 1 person, 5.00%
  5. Aspergillosis (an infection caused by a fungus called aspergillus): 1 person, 5.00%

* Approximation only. Some reports may have incomplete information.

Do you take Itraconazole and have Sedation?

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Related studies:

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

Sedation treatments and more:

How severe was Sedation and when was it recovered:

Expand to all the drugs that have ingredients of itraconazole:

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 Itraconazole:

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 Sedation:

Browse all the conditions that are associated with Sedation:


How the study uses the data?

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