What the label lists and what reports show
Sirolimus side effects
Sirolimus's FDA label: “The most common (≥30%) adverse reactions observed with sirolimus in clinical studies for organ rejection prophylaxis in recipients of renal transplantation are: peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased …” FAERS holds 13,365 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 pyrexia (524 reports).
- Generic listed
- Boxed warning
Check it at the source: the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA); 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 sirolimus tablets?Sirolimus tablets may cause serious side effects, including: • See "What is the most important information I should know about sirolimus tablets?" • Serious allergic reactions. Tell your doctor or get medical help right away if you get any of following symptoms of an allergic reaction: • swelling of your face, eyes, or mouth • chest pain or tightness • trouble breathing or wheezing • feeling dizzy or faint • throat tightness • rash or peeling of your skin • Swelling (edema). Fluid may collect in your hands and feet and in various tissues of your body, including in the sac around your heart or lungs. Call your doctor if you have trouble breathing. • Poor wound healing. Sirolimus may cause your wounds to heal slowly or not heal well. Tell your doctor if you have any redness or drainage, your wound does not heal, or the wound opens up. […]
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 28, 2026 (SPL set 57fb4d90-3ccb-4a69-af1e-53be83f7a504), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥30%) adverse reactions observed with sirolimus in clinical studies for organ rejection prophylaxis in recipients of renal transplantation are: peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased, constipation, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, and thrombocytopenia.
TABLE 1: ADVERSE REACTIONS OCCURRING AT A FREQUENCY OF ≥20% IN AT LEAST ONE OF THE SIROLIMUS TREATMENT GROUPS IN A STUDY OF PROPHYLAXIS OF ORGAN REJECTION FOLLOWING RENAL TRANSPLANTATION (%) AT ≥ 12 MONTHS…
| Adverse Reaction | 2 mg/day (n = 218) | 5 mg/day (n = 208) | Placebo (n = 124) |
|---|---|---|---|
| Peripheral edema | 54 | 58 | 48 |
| Hypertriglyceridemia | 45 | 57 | 23 |
| Hypertension | 45 | 49 | 48 |
| Hypercholesterolemia | 43 | 46 | 23 |
| Creatinine increased | 39 | 40 | 38 |
| Constipation | 36 | 38 | 31 |
| Abdominal pain | 29 | 36 | 30 |
| Diarrhea | 25 | 35 | 27 |
| Headache | 34 | 34 | 31 |
| Fever | 23 | 34 | 35 |
| Urinary tract infection | 26 | 33 | 26 |
| Anemia | 23 | 33 | 21 |
| Nausea | 25 | 31 | 29 |
| Arthralgia | 25 | 31 | 18 |
| Thrombocytopenia | 14 | 30 | 9 |
| Pain | 33 | 29 | 25 |
| Acne | 22 | 22 | 19 |
| Rash | 10 | 20 | 6 |
| Edema | 20 | 18 | 15 |
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 following adverse reactions are discussed in greater detail in other sections of the label.
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 28, 2026 (SPL set 57fb4d90-3ccb-4a69-af1e-53be83f7a504), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,365 reports list sirolimus among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,150 are coded as a death and 4,559 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 17 reactions below, 8 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?
- Sirolimus: 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