Spiriva and Injection site vesicles - a phase IV clinical study of FDA data

Summary:

Injection site vesicles is reported as a side effect among people who take Spiriva (tiotropium bromide monohydrate), especially for people who are female, 40-49 old, also take Nucala, and have Gastroesophageal reflux disease.

The phase IV clinical study analyzes which people have Injection site vesicles when taking Spiriva. It is created by eHealthMe based on reports of 155,418 people who have side effects when taking Spiriva from the FDA, and is updated regularly.

What is Spiriva?

Spiriva has active ingredients of tiotropium bromide monohydrate. It is often used in chronic obstructive pulmonary disease. eHealthMe is studying from 156,666 Spiriva users. Check the latest studies of Spiriva.

What is Injection site vesicles?

Injection site vesicles (fluid- or air-filled cavity or sac at injection site) is found to be associated with 299 drugs and 387 conditions by eHealthMe. Check the latest studies of Injection site vesicles.

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, 28, 2026

155,418 people reported to have side effects when taking Spiriva.
Among them, 26 people (0.02%) have Injection site vesicles.

Could Spiriva cause Injection site vesicles?

Among these 26 people:

What is the gender of people who have Injection site vesicles when taking Spiriva? *

female: 84 %
male: 16 %

What is the age of people who have Injection site vesicles when taking Spiriva? *

What are other drugs people take besides Spiriva? *

What are other side effects people have besides Injection site vesicles? *

Nasopharyngitis (inflammation of the nasopharynx): 18 people, 69.23%
Rashes (redness): 18 people, 69.23%
Chest Pain: 18 people, 69.23%
Pain: 17 people, 65.38%
Cough: 13 people, 50.00%
Malaise (a feeling of general discomfort or uneasiness): 12 people, 46.15%
Purulent Discharge (discharge that contains pus): 12 people, 46.15%
Injection Site Scab: 11 people, 42.31%
Injection Site Pain: 11 people, 42.31%
Heart Rate Decreased: 11 people, 42.31%

What are the existing conditions these people have? *

Psoriasis (immune-mediated disease that affects the skin): 7 people, 26.92%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 7 people, 26.92%
Migraine (headache): 2 people, 7.69%
Type 2 Diabetes: 1 person, 3.85%
Stress And Anxiety: 1 person, 3.85%
Pain: 1 person, 3.85%
Non-Hodgkin's Lymphoma (malignant (cancer) cells form in the lymph system): 1 person, 3.85%
Lipohypertrophy (a lump under the skin caused by accumulation of extra fat at the site of many subcutaneous injections of insulin): 1 person, 3.85%
Ill-Defined Disorder: 1 person, 3.85%
High Blood Cholesterol: 1 person, 3.85%

* Approximation only. Some reports may have incomplete information.

Do you take Spiriva and have Injection site vesicles?

- Check whether Injection site vesicles 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 Spiriva:

Spiriva (156,666 reports)

Injection site vesicles treatments and more:

Injection site vesicles (5,489 reports)

How severe was Injection site vesicles and when was it recovered:

Injection site vesicles in Spiriva

Expand to all the drugs that have ingredients of tiotropium bromide monohydrate:

Injection site vesicles and drugs with ingredients of tiotropium bromide monohydrate

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 Spiriva:

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 Injection site vesicles:

Injection site vesicles (299 drugs)

Browse all the conditions that are associated with Injection site vesicles:

Injection site vesicles (387 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on tiotropium bromide monohydrate (the active ingredients of Spiriva) and Spiriva (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.