Stivarga 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 Stivarga (regorafenib), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Zofran, and have Colon cancer.

The phase IV clinical study analyzes which people have Mental status changes when taking Stivarga. It is created by eHealthMe based on reports of 9,530 people who have side effects when taking Stivarga from the FDA, and is updated regularly.

What is Stivarga?

Stivarga has active ingredients of regorafenib. eHealthMe is studying from 9,539 Stivarga users. Check the latest studies of Stivarga.

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 1,491 drugs and 1,760 conditions by eHealthMe. Check the latest studies of Mental status changes.

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, 03, 2026

9,530 people reported to have side effects when taking Stivarga.
Among them, 22 people (0.23%) have Mental status changes.

Could Stivarga cause Mental status changes?

Among these 22 people:

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

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

female: 20 %
male: 80 %

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

What are other drugs people take besides Stivarga? *

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

Fatigue (feeling of tiredness): 7 people, 31.82%
Fever: 5 people, 22.73%
Urinary Tract Infection: 4 people, 18.18%
Abdominal Pain: 3 people, 13.64%
Mucosal Inflammation (infection of mucous membrane): 3 people, 13.64%
Sepsis (a severe blood infection that can lead to organ failure and death): 2 people, 9.09%
High Blood Pressure: 2 people, 9.09%
Hoarseness Or Changing Voice: 2 people, 9.09%
Hypersensitivity: 2 people, 9.09%
Weakness: 2 people, 9.09%

What are the existing conditions these people have? *

Colon Cancer: 6 people, 27.27%
Nausea (feeling of having an urge to vomit): 5 people, 22.73%
Sleep Disorder: 3 people, 13.64%
Hepatic Encephalopathy (spectrum of neuropsychiatric abnormalities in patients with liver failure): 3 people, 13.64%
Cerebral Disorder (brain disease): 3 people, 13.64%
Nausea And Vomiting: 3 people, 13.64%
Gastrointestinal Haemorrhage (bleeding gastrointestinal tract): 3 people, 13.64%
Hepatocellular Carcinoma (liver cancer): 2 people, 9.09%
Rectal Cancer Metastatic (cancer of rectum spreads to other): 2 people, 9.09%
Abdominal Pain: 2 people, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Stivarga 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 Stivarga:

Stivarga (9,539 reports)

Browse all side effects of Stivarga:

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 (1,491 drugs)

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

Mental status changes (1,760 conditions)

How the study uses the data?

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