Prograftacrolimus
According to the FDA label: Tacrolimus capsules are calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney or heart transplants and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants.
148,397 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Prograf in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Off Label Use 14,286 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 9,993 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Drug Interaction 6,197 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Product Use in Unapproved Indication 6,169 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Acute Kidney Injury 5,785 reports
A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Full definition in the glossary →Diarrhoea 5,687 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →- Transplant Rejection 4,777 reports
Death 4,761 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Pyrexia 4,723 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Cytomegalovirus Infection 4,434 reports
An infection with a common virus, often called CMV, that can be serious for people with weakened immune systems.
Full definition in the glossary →Pneumonia 4,362 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →COVID-19 3,815 reports
The illness caused by the SARS-CoV-2 coronavirus.
Full definition in the glossary →Toxicity to Various Agents 3,740 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Renal Impairment 3,492 reports
Reduced kidney function. Renal means related to the kidneys. This is a broad term for kidneys not working as well as normal.
Full definition in the glossary →Sepsis 3,413 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 72,411 |
| Female | 56,869 |
| Unknown | 840 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 15,131 |
| 18-34 | 16,169 |
| 35-49 | 21,880 |
| 50-64 | 35,797 |
| 65-74 | 17,148 |
| 75+ | 4,425 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Prograf. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 94,249 |
| Hospitalization | 59,665 |
| Death | 24,747 |
| Non-Serious | 14,594 |
| Life-Threatening | 11,721 |
| Disability | 2,179 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Prograf. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 4 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 698 |
| 2005 | 876 |
| 2006 | 913 |
| 2007 | 1,485 |
| 2008 | 1,998 |
| 2009 | 2,169 |
| 2010 | 2,343 |
| 2011 | 3,919 |
| 2012 | 4,663 |
| 2013 | 3,853 |
| 2014 | 4,552 |
| 2015 | 5,029 |
| 2016 | 6,022 |
| 2017 | 8,088 |
| 2018 | 10,990 |
| 2019 | 10,664 |
| 2020 | 12,131 |
| 2021 | 11,470 |
| 2022 | 11,894 |
| 2023 | 13,251 |
| 2024 | 14,295 |
| 2025 | 14,147 |
| 2026 (partial) | 2,939 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Prograf
In FDA adverse event reports that mention Prograf, these medications appeared most often in the same report.
- Mycophenolate Mofetil (56,354 reports)
- Prednisone (39,168 reports)
- Prednisolone (23,703 reports)
- Methylprednisolone (17,620 reports)
- Mycophenolic Acid (15,005 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026