Tolvaptan and Angioedema - a phase IV clinical study of FDA data

Summary:

Angioedema is reported as a side effect among people who take Tolvaptan (tolvaptan), especially for people who are male, 50-59 old, also take Amlodipine, and have Blood pressure abnormal.

The phase IV clinical study analyzes which people have Angioedema when taking Tolvaptan. It is created by eHealthMe based on reports of 5,682 people who have side effects when taking Tolvaptan from the FDA, and is updated regularly.

What is Tolvaptan?

Tolvaptan has active ingredients of tolvaptan. eHealthMe is studying from 5,685 Tolvaptan users. Check the latest studies of Tolvaptan.

What is Angioedema?

Angioedema (rapid swelling of the dermis) is found to be associated with 1,199 drugs and 2,100 conditions by eHealthMe. Check the latest studies of Angioedema.

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

5,682 people reported to have side effects when taking Tolvaptan.
Among them, 50 people (0.88%) have Angioedema.

Among these 50 people:

What is the gender of people who have Angioedema when taking Tolvaptan? *

female: 8.51 %
male: 91.49 %

What is the age of people who have Angioedema when taking Tolvaptan? *

What are other drugs people take besides Tolvaptan? *

Amlodipine: 26 people, 52.00%
Prinivil: 22 people, 44.00%
Allopurinol: 10 people, 20.00%
Venlafaxine Hydrochloride: 7 people, 14.00%
Ranitidine: 7 people, 14.00%
Lisinopril: 7 people, 14.00%
Epinephrine: 7 people, 14.00%
Synthroid: 3 people, 6.00%
Hydrochlorothiazide: 3 people, 6.00%
Amlodipine Besylate: 3 people, 6.00%

What are other side effects people have besides Angioedema? *

Drug Ineffective: 29 people, 58.00%
Speech Impairment (Adult) (inability to speak (adult)): 15 people, 30.00%
Face Oedema (swelling of face): 15 people, 30.00%
Tongue Oedema (swelling of tongue): 14 people, 28.00%
Eyelid Oedema (eyelids are swollen and contain excessive fluid): 14 people, 28.00%
Death: 10 people, 20.00%
Dizziness: 5 people, 10.00%
Hypersensitivity: 4 people, 8.00%
Hypotension (abnormally low blood pressure): 3 people, 6.00%
Lip Oedema (swelling of lip): 3 people, 6.00%

What are the existing conditions these people have? *

Hyperthyroidism (over activity of the thyroid gland): 3 people, 6.00%
High Blood Pressure: 3 people, 6.00%
Blood Pressure Abnormal: 3 people, 6.00%
Gout (uric acid crystals building up in the body): 2 people, 4.00%
Deep Venous Thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis): 2 people, 4.00%
Chronic Kidney Disease: 2 people, 4.00%
Indigestion: 1 person, 2.00%
Hyponatremia (abnormally low level of sodium in the blood; associated with dehydration): 1 person, 2.00%
Coronary Heart Disease (narrowing or blockage of the coronary arteries): 1 person, 2.00%
Cardiac Failure Acute: 1 person, 2.00%

* Approximation only. Some reports may have incomplete information.

Do you take Tolvaptan and have Angioedema?

- Check whether Angioedema 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 Tolvaptan:

Tolvaptan (5,685 reports)

Angioedema treatments and more:

Angioedema (44,989 reports)

Browse all side effects of Tolvaptan:

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 Angioedema:

Angioedema (1,199 drugs)

Browse all the conditions that are associated with Angioedema:

Angioedema (2,100 conditions)

Related publications that referenced our studies

Banaga, Y., Mohmmed, K., Mustafa, H., & Barrett, J, "Angioedema 2 months after Administration of Rivaroxaban (Xarelto)", J Clin Case Rep, 2014 Jan .
Banaga, Y., Mohmmed, K., Mustafa, H., & Barrett, J, "Angioedema 2 months after Administration of Rivaroxaban (Xarelto)", J Clin Case Rep, 2014 Jan .

How the study uses the data?

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