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

Summary:

Sinus headache is reported as a side effect among people who take Sudafed 12 hour (pseudoephedrine hydrochloride), especially for people who are female, 40-49 old, have been taking the drug for < 1 month also take Ambien, and have Metastases to bone.

The phase IV clinical study analyzes which people have Sinus headache when taking Sudafed 12 hour. It 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.

What is Sinus headache?

Sinus headache (headache caused by sinus infections) is found to be associated with 684 drugs and 797 conditions by eHealthMe. Check the latest studies of Sinus headache.

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, 01, 2026

3,693 people reported to have side effects when taking Sudafed 12 hour.
Among them, 22 people (0.6%) have Sinus headache.

Could Sudafed 12 hour cause Sinus headache?

Among these 22 people:

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

What is the gender of people who have Sinus headache when taking Sudafed 12 hour? *

female: 80.95 %
male: 19.05 %

What is the age of people who have Sinus headache when taking Sudafed 12 hour? *

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

What are other side effects people have besides Sinus headache? *

Fever: 9 people, 40.91%
Pain: 9 people, 40.91%
Wound Dehiscence (a surgical incision reopens either internally or externally): 8 people, 36.36%
Mucosal Atrophy (wasting away of mucous membrane): 8 people, 36.36%
Primary Sequestrum (piece of dead bone that has become separated during the process of necrosis from normal/sound bone): 8 people, 36.36%
Dental Caries: 8 people, 36.36%
Osteonecrosis Of Jaw (death of bone of jaw): 8 people, 36.36%
Osteomyelitis (infection of bone): 8 people, 36.36%
Oral Disorder (mouth disease): 8 people, 36.36%
Mouth Cyst (a fluid filled sac in mouth): 8 people, 36.36%

What are the existing conditions these people have? *

Sinusitis (inflammation of sinus): 8 people, 36.36%
Metastases To Bone (cancer spreads to bone): 8 people, 36.36%
Migraine (headache): 3 people, 13.64%
Asthma: 3 people, 13.64%
Indigestion: 3 people, 13.64%
Sleep Disorder: 2 people, 9.09%
Dyspnea (difficult or laboured breathing): 2 people, 9.09%
Faeces Hard: 2 people, 9.09%
Itching: 2 people, 9.09%
Urticaria (rash of round, red welts on the skin that itch intensely): 2 people, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Sudafed 12 hour and have Sinus headache?

- Check whether Sinus headache 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 Sudafed 12 hour:

Sudafed 12 hour (4,687 reports)

Sinus headache treatments and more:

Sinus headache (9,129 reports)

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 Sinus headache:

Sinus headache (684 drugs)

Browse all the conditions that are associated with Sinus headache:

Sinus headache (797 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.