What the label lists and what reports show
Tacrolimus side effects
Tacrolimus's FDA label: “The most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation …” FAERS holds 156,020 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is acute kidney injury (6,154 reports).
- Generic listed
- Boxed warning
Check it at the source: the tacrolimus FDA label on DailyMed (effective July 17, 2026, Stellon Biotech Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of tacrolimus capsules?Tacrolimus capsules may cause serious side effects, including: • See “What is the most important information I should know about tacrolimus capsules?” • problems from medicine errors. People who take tacrolimus capsules have sometimes been given the wrong type of tacrolimus product. Tacrolimus extended-release medicines are not the same as tacrolimus capsules and cannot be substituted for each other. Check your tacrolimus capsules when you get a new prescription and before you take it to make sure you have received tacrolimus capsules. • Check with the pharmacist and call your healthcare provider if you think you were given the wrong medicine. • high blood sugar (diabetes). Your healthcare provider may do blood tests to check for diabetes while you take tacrolimus capsules. […]
Source: FDA drug label (tacrolimus), Glenmark Pharmaceuticals Inc., USA, effective January 21, 2026 (SPL set 4b310c6b-e035-4e44-9573-4001d58b2ad5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation, diarrhea, headache, abdominal pain, insomnia, paresthesia, peripheral edema, nausea, hyperkalemia, hypomagnesemia, and hyperlipemia.
Table 4. Kidney Transplantation: Adverse Reactions Occurring in ≥ 15% of Patients Treated with Tacrolimus in Conjunction with Azathioprine (AZA)
| Reaction | Tacrolimus/AZA (N = 205) | Cyclosporine/AZA (N = 207) |
|---|---|---|
| Tremor | 54% | 34% |
| Headache | 44% | 38% |
| Insomnia | 32% | 30% |
| Paresthesia | 23% | 16% |
| Dizziness | 19% | 16% |
| Diarrhea | 44% | 41% |
| Nausea | 38% | 36% |
| Constipation | 35% | 43% |
| Vomiting | 29% | 23% |
| Dyspepsia | 28% | 20% |
| Hypertension | 50% | 52% |
| Chest Pain | 19% | 13% |
| Creatinine Increased | 45% | 42% |
| Urinary Tract Infection | 34% | 35% |
| Hypophosphatemia | 49% | 53% |
| Hypomagnesemia | 34% | 17% |
| Hyperlipemia | 31% | 38% |
| Hyperkalemia | 31% | 32% |
| Diabetes Mellitus | 24% | 9% |
| Hypokalemia | 22% | 25% |
| Hyperglycemia | 22% | 16% |
| Edema | 18% | 19% |
| Anemia | 30% | 24% |
| Leukopenia | 15% | 17% |
| Infection | 45% | 49% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation, diarrhea, headache, abdominal pain, insomnia, paresthesia, peripheral edema, nausea, hyperkalemia, hypomagnesemia, and hyperlipemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Concord Biotech Limited at Telephone: 1-855-407-0586 or FDA at 1-800-FDA-1088 or www.fda.g ov/medwatch.
Source: FDA drug label, Stellon Biotech Inc., effective July 17, 2026 (SPL set 6b89e8a4-9f11-42e3-8e79-fe617e7c461f), via openFDA; the full label on DailyMed
What do FAERS reports show?
156,020 reports list tacrolimus among the medicines taken, each a report of something that happened, not proof the medicine caused it; 25,784 are coded as a death and 62,864 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tacrolimus: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions