Codeine and Mental status changes - a phase IV clinical study of FDA data

Summary:

Mental status changes is reported as a side effect among people who take Codeine (codeine sulfate), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Zometa, and have Depression.

The phase IV clinical study analyzes which people have Mental status changes when taking Codeine. It is created by eHealthMe based on reports of 41,713 people who have side effects when taking Codeine from the FDA, and is updated regularly.

What is Codeine?

Codeine has active ingredients of codeine sulfate. It is often used in pain. eHealthMe is studying from 42,342 Codeine users. Check the latest studies of Codeine.

What is Mental status changes?

Mental status changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation) is found to be associated with 1,508 drugs and 1,750 conditions by eHealthMe. Check the latest studies of Mental status changes.

On Apr, 26, 2026

41,713 people reported to have side effects when taking Codeine.
Among them, 44 people (0.11%) have Mental status changes.

Could Codeine cause Mental status changes?

Among these 44 people:

How long have people been on Codeine when they have Mental status changes? *

What is the gender of people who have Mental status changes when taking Codeine? *

female: 52.63 %
male: 47.37 %

What is the age of people who have Mental status changes when taking Codeine? *

What are other drugs people take besides Codeine? *

What are other side effects people have besides Mental status changes? *

Depression: 20 people, 45.45%
Stress And Anxiety: 15 people, 34.09%
Osteonecrosis Of Jaw (death of bone of jaw): 12 people, 27.27%
Agitation (state of anxiety or nervous excitement): 12 people, 27.27%
High Blood Pressure: 12 people, 27.27%
Thrombocytopenia (decrease of platelets in blood): 12 people, 27.27%
Atelectasis (partial or complete collapse of the lung): 12 people, 27.27%
Fever: 11 people, 25.00%
Metastases To Bone (cancer spreads to bone): 11 people, 25.00%
Anaemia (lack of blood): 11 people, 25.00%

What are the existing conditions these people have? *

Depression: 9 people, 20.45%
Affective Disorder (mental disorder): 8 people, 18.18%
Brain Oedema (excess accumulation of fluid in the intracellular or extracellular spaces of the brain): 8 people, 18.18%
Hypercalcaemia (elevated calcium (ca+) level in the blood): 2 people, 4.55%
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): 2 people, 4.55%
Breast Cancer: 2 people, 4.55%
Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 2 people, 4.55%
Breast Cancer Metastatic: 2 people, 4.55%
Cough: 2 people, 4.55%
Transient Ischaemic Attack (a transient episode of neurologic dysfunction caused by ischemia (loss of blood flow)): 2 people, 4.55%

* Approximation only. Some reports may have incomplete information.

Do you take Codeine and have Mental status changes?

- Check whether Mental status changes 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 Codeine:

Codeine (42,342 reports)

Browse all side effects of Codeine:

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 Mental status changes:

Mental status changes (1,508 drugs)

Browse all the conditions that are associated with Mental status changes:

Mental status changes (1,750 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on codeine sulfate (the active ingredients of Codeine) and Codeine (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.