Restasis and Injection site swelling - a phase IV clinical study of FDA data

Summary:

Injection site swelling is reported as a side effect among people who take Restasis (cyclosporine), especially for people who are female, 60+ old, also take Enbrel, and have Rheumatoid arthritis.

The phase IV clinical study analyzes which people have Injection site swelling when taking Restasis. It is created by eHealthMe based on reports of 34,716 people who have side effects when taking Restasis from the FDA, and is updated regularly.

What is Restasis?

Restasis has active ingredients of cyclosporine. It is often used in dry eyes. eHealthMe is studying from 35,199 Restasis users. Check the latest studies of Restasis.

What is Injection site swelling?

Injection site swelling is found to be associated with 1,056 drugs and 1,116 conditions by eHealthMe. Check the latest studies of Injection site swelling.

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

34,716 people reported to have side effects when taking Restasis.
Among them, 77 people (0.22%) have Injection site swelling.

Could Restasis cause Injection site swelling?

Among these 77 people:

What is the gender of people who have Injection site swelling when taking Restasis? *

female: 94.67 %
male: 5.33 %

What is the age of people who have Injection site swelling when taking Restasis? *

What are other drugs people take besides Restasis? *

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

Injection Site Erythema (redness at injection site): 42 people, 54.55%
Injection Site Pruritus (severe itching at injection site): 24 people, 31.17%
Injection Site Pain: 20 people, 25.97%
Urinary Tract Infection: 14 people, 18.18%
Injection Site Bruising: 14 people, 18.18%
Injection Site Reaction: 12 people, 15.58%
Injection Site Discoloration: 11 people, 14.29%
Carpal Tunnel Syndrome (nerve compression at wrist results numbness weakness, pain , swelling): 10 people, 12.99%
Injection Site Warmth: 10 people, 12.99%
Ear Discomfort: 8 people, 10.39%

What are the existing conditions these people have? *

Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 31 people, 40.26%
Immunodeficiency Common Variable: 8 people, 10.39%
Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 7 people, 9.09%
B-Lymphocyte Abnormalities (abnormal population of b lymphocytes in the blood, bone marrow, or tissues): 5 people, 6.49%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 4 people, 5.19%
Asthma: 4 people, 5.19%
Psoriasis (immune-mediated disease that affects the skin): 4 people, 5.19%
Pain: 4 people, 5.19%
Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 3 people, 3.90%
Dermatitis Atopic (inflammatory, chronically relapsing, non-contagious and pruritic skin disorder): 3 people, 3.90%

* Approximation only. Some reports may have incomplete information.

Do you take Restasis and have Injection site swelling?

- Check whether Injection site swelling 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 Restasis:

Restasis (35,199 reports)

Browse all side effects of Restasis:

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 swelling:

Injection site swelling (1,056 drugs)

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

Injection site swelling (1,116 conditions)

Related publications that referenced our studies

O’Brien FE, O’Connor RM, Clarke G, Donovan MD, Dinan TG, Griffin BT, Cryan JF, "The P-glycoprotein inhibitor cyclosporin A differentially influences behavioural and neurochemical responses to the antidepressant escitalopram", Behavioural brain research, 2014 Mar .
O’Brien FE, O’Connor RM, Clarke G, Donovan MD, Dinan TG, Griffin BT, Cryan JF, "The P-glycoprotein inhibitor cyclosporin A differentially influences behavioural and neurochemical responses to the antidepressant escitalopram", Behavioural brain research, 2014 Mar .

How the study uses the data?

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