Pharmacologic class (EPC) · 11 drug pages

Calcineurin inhibitor immunosuppressant: adverse event reports filed with FDA

206,378 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

206,378
reports across the class: 1% of all reports; 22,043
reports, 12 months to June 2026: 20,769 in the 12 months before; 79.1%
marked serious by the reporter: 57.4% across all reports; 11
drugs with a page: brand and generic names counted separately

Calcineurin inhibitor immunosuppressant is a pharmacologic class (an FDA Established Pharmacologic Class) with 11 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 206,378 adverse event reports received by FDA, 1% of the database, from January 2004 to June 2026.

22,043 reports arrived in the 12 months to June 2026, close to the 20,769 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 79.1% of the class's reports are marked serious, 15.3% record death among the outcomes and 32.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (9.6%), off label use (8.9%) and eye irritation (4.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Tacrolimus	generic	95,165	9,301	93.5%	Off label use
Cyclosporine	generic	38,688	4,609	94.1%	Drug ineffective
PrografTacrolimus	brand	20,427	415	89.6%	Off label use
RestasisCyclosporine	brand	18,243	610	8.9%	Eye irritation
NeoralCyclosporine	brand	11,363	133	94.5%	Drug ineffective
LupkynisVoclosporin	brand	8,467	2,444	20.3%	Therapy interrupted
VevyeCyclosporine ophthalmic solution	brand	4,794	3,506	0.7%	Eye irritation
EnvarsusTacrolimus	brand	3,776	407	84.6%	Off label use
CequaCyclosporine	brand	3,041	598	4.6%	Eye irritation
SandimmuneCyclosporine	brand	1,871	7	92.8%	Pyrexia
GengrafCyclosporine	brand	543	13	59.7%	Death

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected9.6%19,789
Off label useused for a purpose or in a way not on the label8.9%18,434
Eye irritationeye irritation4.5%9,201
Product use in unapproved indicationused for a purpose not on the label4.3%8,898
Drug interactionan interaction between medicines3.7%7,666
Acute kidney injurysudden loss of kidney function3.1%6,372
Diarrhoealoose or frequent stools3.1%6,350
Pyrexiafever3%6,252
Cytomegalovirus infection2.9%5,976
Pneumonialung infection2.8%5,881
Deaththe patient died; cause not stated by this term2.8%5,712
Transplant rejection2.8%5,704
Renal impairmentreduced kidney function2.4%5,007
Condition aggravatedthe condition being treated got worse2.4%4,863
Covid-19COVID-19 infection2.1%4,379
Headachehead pain2.1%4,372
Sepsisa severe body-wide response to infection2.1%4,370
Nauseafeeling sick2.1%4,366
Hypertensionhigh blood pressure2.1%4,340
Toxicity to various agentspoisoning or toxic effect of one or more substances2.1%4,269
Blood creatinine increasedraised creatinine, a kidney test2%4,060
Post transplant lymphoproliferative disorder1.8%3,631
Thrombotic microangiopathy1.7%3,533
Vomitingbeing sick1.7%3,503
Eye paineye pain1.7%3,466

Solid bar: share of all class reports. Hollow bar: the median share across the 11 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.3%31,490

Life-threatening6.7%13,824

Hospitalisation (initial or prolonged)32.4%66,856

Disability1.3%2,738

Congenital anomaly0.3%711

Other serious56.9%117,346

Not serious20.9%43,153

Patient age

Under 21.3%2,690

2 to 114.6%9,490

12 to 173.2%6,547

18 to 4417.7%36,615

45 to 6426.4%54,548

65 to 7410.6%21,933

75 and over4.1%8,491

Age not given32%66,064

Who reported

Physician27.2%56,225

Pharmacist4.5%9,359

Other health professional40.1%82,735

Lawyer0%56

Consumer or non-health professional25.1%51,875

Not given3%6,128

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Calcineurin inhibitor immunosuppressant reports

Which drugs are in the Calcineurin inhibitor immunosuppressant class on this site?

Tacrolimus, Cyclosporine, Prograf, Restasis, Neoral and Lupkynis and 5 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

206,378 reports through June 2026, 22,043 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (9.6%), off label use (8.9%), eye irritation (4.5%), product use in unapproved indication (4.3%) and drug interaction (3.7%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.