What the label lists and what reports show
Temsirolimus side effects
Temsirolimus's FDA label: “The most common (≥30%) adverse reactions observed with TORISEL are rash, asthenia, mucositis, nausea, edema, and anorexia.” FAERS holds 4,502 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 dyspnoea (215 reports).
- Generic listed
Check it at the source: the temsirolimus FDA label on DailyMed (effective December 26, 2025, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common (≥30%) adverse reactions observed with TORISEL are rash, asthenia, mucositis, nausea, edema, and anorexia.
Table 1 – Adverse Reactions Reported in at Least 10% of Patients Who Received 25 mg IV TORISEL or IFN-α in the Randomized Trial
| Reaction | All Grades Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0. n (%) | Grades 3&4 n (%) | All Grades n (%) | Grades 3&4 n (%) |
|---|---|---|---|---|
| Asthenia | 106 (51) | 23 (11) | 127 (64) | 52 (26) |
| Edema Includes edema, facial edema, and peripheral edema | 73 (35) | 7 (3) | 21 (11) | 1 (1) |
| Pain | 59 (28) | 10 (5) | 31 (16) | 4 (2) |
| Pyrexia | 50 (24) | 1 (1) | 99 (50) | 7 (4) |
| Weight Loss | 39 (19) | 3 (1) | 50 (25) | 4 (2) |
| Headache | 31 (15) | 1 (1) | 30 (15) | 0 (0) |
| Chest Pain | 34 (16) | 2 (1) | 18 (9) | 2 (1) |
| Chills | 17 (8) | 1 (1) | 59 (30) | 3 (2) |
| Mucositis Includes aphthous stomatitis, glossitis, mouth ulceration, mucositis, and… | 86 (41) | 6 (3) | 19 (10) | 0 (0) |
| Anorexia | 66 (32) | 6 (3) | 87 (44) | 8 (4) |
| Nausea | 77 (37) | 5 (2) | 82 (41) | 9 (5) |
| Diarrhea | 56 (27) | 3 (1) | 40 (20) | 4 (2) |
| Abdominal Pain | 44 (21) | 9 (4) | 34 (17) | 3 (2) |
| Constipation | 42 (20) | 0 (0) | 36 (18) | 1 (1) |
| Vomiting | 40 (19) | 4 (2) | 57 (29) | 5 (3) |
| Infections Includes infections not otherwise specified (NOS) and the following infections… | 42 (20) | 6 (3) | 19 (10) | 4 (2) |
| Urinary tract infection Includes cystitis, dysuria, hematuria, urinary frequency, and… | 31 (15) | 3 (1) | 24 (12) | 3 (2) |
| Pharyngitis | 25 (12) | 0 (0) | 3 (2) | 0 (0) |
| Rhinitis | 20 (10) | 0 (0) | 4 (2) | 0 (0) |
| Back Pain | 41 (20) | 6 (3) | 28 (14) | 7 (4) |
| Arthralgia | 37 (18) | 2 (1) | 29 (15) | 2 (1) |
| Myalgia | 16 (8) | 1 (1) | 29 (15) | 2 (1) |
| Dyspnea | 58 (28) | 18 (9) | 48 (24) | 11 (6) |
| Cough | 53 (26) | 2 (1) | 29 (15) | 0 (0) |
| Epistaxis | 25 (12) | 0 (0) | 7 (4) | 0 (0) |
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 serious adverse reactions have been associated with TORISEL in clinical trials and are discussed in greater detail in other sections of the label [see Warnings and Precautions (5) ]. • Hypersensitivity/Infusion Reactions [see Warnings and Precautions (5.1) ] • Hepatic Impairment [see Warnings and Precautions (5.2) ] • Hyperglycemia/Glucose Intolerance [see Warnings and Precautions (5.3) ] • Infections [see Warnings and Precautions (5.4) ] • Interstitial Lung Disease [see Warnings and Precautions (5.5) ] • Hyperlipidemia [see Warnings and Precautions (5.6) ] • Bowel Perforation [see Warnings and Precautions (5.7) ] • Renal Failure [see Warnings and Precautions (5.8) ] • Wound Healing Complications [see Warnings and Precautions (5.9) ] • Intracerebral Hemorrhage [see Warnings and Precautions (5.10) ] The most common (≥30%) adverse reactions observed with TORISEL are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common (≥30%) laboratory abnormalities observed with TORISEL are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, lymphopenia, elevated alkaline phosphatase, elevated serum creatinine, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia. The most common adverse reactions (incidence ≥30%) are rash, asthenia, mucositis, nausea, edema, and anorexia. …
Source: FDA drug label, NDA022088 (Pf Prism Cv), as published by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective December 26, 2025 (SPL set 95b7dc92-2180-42f1-8699-3c28f609e674), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,502 reports list temsirolimus among the medicines taken, each a report of something that happened, not proof the medicine caused it; 967 are coded as a death and 2,003 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 21 reactions below, 14 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?
- Temsirolimus: 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