Fioricet and Middle ear effusion - a phase IV clinical study of FDA data

Summary:

Middle ear effusion is reported as a side effect among people who take Fioricet (acetaminophen; butalbital; caffeine), especially for people who are female, 40-49 old, also take Aldactone, and have Immunodeficiency common variable.

The phase IV clinical study analyzes which people have Middle ear effusion when taking Fioricet. It is created by eHealthMe based on reports of 11,479 people who have side effects when taking Fioricet from the FDA, and is updated regularly.

What is Fioricet?

Fioricet has active ingredients of acetaminophen; butalbital; caffeine. It is often used in migraine. eHealthMe is studying from 12,423 Fioricet users. Check the latest studies of Fioricet.

What is Middle ear effusion?

Middle ear effusion (fluid in middle ear) is found to be associated with 333 drugs and 446 conditions by eHealthMe. Check the latest studies of Middle ear effusion.

On Jul, 14, 2026

11,479 people reported to have side effects when taking Fioricet.
Among them, 12 people (0.1%) have Middle ear effusion.

Could Fioricet cause Middle ear effusion?

Among these 12 people:

What is the gender of people who have Middle ear effusion when taking Fioricet? *

female: 100 %
male: 0.0 %

What is the age of people who have Middle ear effusion when taking Fioricet? *

What are other drugs people take besides Fioricet? *

What are other side effects people have besides Middle ear effusion? *

Weight Decreased: 9 people, 75.00%
Breast Lump (localized swelling that feels different from the surrounding breast tissue): 9 people, 75.00%
Injection Site Pain: 9 people, 75.00%
Urinary Tract Infection: 9 people, 75.00%
Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 9 people, 75.00%
Respiratory Tract Infection Viral: 7 people, 58.33%
Rashes (redness): 6 people, 50.00%
Anal Fissure: 6 people, 50.00%
Pharyngitis Streptococcal (inflammation of the pharynx caused by infection from. streptococcus): 5 people, 41.67%
The Flu (the flu is caused by an influenza virus): 5 people, 41.67%

What are the existing conditions these people have? *

Immunodeficiency Common Variable: 9 people, 75.00%
Primary Pulmonary Hypertension (primary high blood pressure that affects the arteries in the lungs and the right side of your heart): 2 people, 16.67%

* Approximation only. Some reports may have incomplete information.

Do you take Fioricet and have Middle ear effusion?

- Check whether Middle ear effusion 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 Fioricet:

Fioricet (12,423 reports)

Middle ear effusion treatments and more:

Middle ear effusion (2,776 reports)

How severe was Middle ear effusion and when was it recovered:

Middle ear effusion in Fioricet

Expand to all the drugs that have ingredients of acetaminophen; butalbital; caffeine:

Middle ear effusion and drugs with ingredients of acetaminophen; butalbital; caffeine

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 Fioricet:

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 Middle ear effusion:

Middle ear effusion (333 drugs)

Browse all the conditions that are associated with Middle ear effusion:

Middle ear effusion (446 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on acetaminophen; butalbital; caffeine (the active ingredients of Fioricet) and Fioricet (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.