RESTASIS FDA MedWatch Direct Reports Summary

These tables and charts are created from 1,375 voluntary U.S. reports for RESTASIS (CYCLOSPORINE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS RESTASIS Report.

Top Adverse Effects Associated with RESTASIS (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	HEADACHE	108
2	NAUSEA	90
3	EYE IRRITATION	87
4	FATIGUE	85
5	VISION BLURRED	85
6	DIZZINESS	83
7	EYE PAIN	79
8	PAIN	64
9	ITCHING	63
10	DRUG INEFFECTIVE	62
11	SHORTNESS OF BREATH	60
12	DIARRHEA	59
13	EYE RED	49
14	RASH	49
15	PRODUCT SUBSTITUTION ISSUE	44
16	PAIN IN EXTREMITY	43
17	THERAPY CESSATION	43
18	THERAPY INTERRUPTED	41
19	DEATH	40
20	CONDITION AGGRAVATED	38
21	DRY EYE	38
22	INSOMNIA	38
23	JOINT PAIN	36
24	LACK OF STRENGTH AND ENERGY (ASTHENIA)	36
25	FEELING ABNORMAL	36

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RESTASIS Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
181	1165	29	1,375

Medwatch Reporter Type	Count
Consumer	630
Physician	29
Pharmacist	162
Other Health Professional	200

Top Indications

Product used for unknown indication
Dry eye
Sjogren's syndrome
Meibomian gland dysfunction
Cataract operation

Type of Outcome Reported
Serious: 919
Not Serious: 456
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 1374
Concomitant Drugs: 1199
Note: A single MedWatch report can list more than one drug. This summary includes RESTASIS identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

RESTASIS (CYCLOSPORINE) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with RESTASIS? Rate RESTASIS at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.