Sudafed 12 hour and Death - a phase IV clinical study of FDA data

Summary:

Death is reported as a side effect among people who take Sudafed 12 hour (pseudoephedrine hydrochloride), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Zometa, and have Osteoporosis.

The study is created by eHealthMe based on reports of 3,693 people who have side effects when taking Sudafed 12 hour from the FDA, and is updated regularly.

What is Sudafed 12 hour?

Sudafed 12 hour has active ingredients of pseudoephedrine hydrochloride. It is often used in nasal congestion. eHealthMe is studying from 4,687 Sudafed 12 hour users. Check the latest studies of Sudafed 12 hour.

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, 26, 2026

3,693 people reported to have side effects when taking Sudafed 12 hour.
Among them, 33 people (0.89%) died.

Among these 33 people:

How long have people been on Sudafed 12 hour when they died? *

What is the gender of people who died when taking Sudafed 12 hour? *

female: 71.88 %
male: 28.12 %

What is the age of people who died when taking Sudafed 12 hour? *

What are other drugs people take besides Sudafed 12 hour? *

What are other side effects people have before they died? *

Pain: 16 people, 48.48%
Injury: 16 people, 48.48%
Pleural Effusion (water on the lungs): 15 people, 45.45%
Lymph Follicular Hypertrophy (an increase in the size of the lymph node follicles): 14 people, 42.42%
Anaemia (lack of blood): 14 people, 42.42%
Osteomyelitis (infection of bone): 14 people, 42.42%
Cardiac Failure Congestive: 14 people, 42.42%
Osteonecrosis Of Jaw (death of bone of jaw): 14 people, 42.42%
Dyspnea (difficult or laboured breathing): 13 people, 39.39%
Bone Disorder: 12 people, 36.36%

What are the existing conditions these people have? *

Bone Loss: 9 people, 27.27%
Osteoporosis (bones weak and more likely to break): 9 people, 27.27%
Sinusitis (inflammation of sinus): 5 people, 15.15%
Metastases To Bone (cancer spreads to bone): 5 people, 15.15%
Breast Cancer: 4 people, 12.12%
Stress And Anxiety: 1 person, 3.03%
High Blood Pressure: 1 person, 3.03%
Asthma: 1 person, 3.03%
Facial Pain: 1 person, 3.03%
Heart Rate Irregular: 1 person, 3.03%

* Approximation only. Some reports may have incomplete information.

Related studies:

Effectiveness of, long term effects of, and alternative drugs to Sudafed 12 hour:

Sudafed 12 hour (4,687 reports)

Expand to all the drugs that have ingredients of pseudoephedrine hydrochloride:

Death and drugs with ingredients of pseudoephedrine hydrochloride (175 reports)

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 Sudafed 12 hour:

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 Death:

Death (3,114 drugs)

Browse all the conditions that are associated with Death:

Death (3,686 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on pseudoephedrine hydrochloride (the active ingredients of Sudafed 12 hour) and Sudafed 12 hour (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.