Prescription medicine
Temsirolimus Brand names: Torisel
Temsirolimus (Torisel) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 4 generic labelers.
- 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 NDA 22088 record on Drugs@FDA; every temsirolimus label on DailyMed.
Highlights of the record
FDA label of December 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTORISEL is indicated for the treatment of advanced renal cell carcinoma.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- May 30, 2007 Torisel, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first July 30, 2018; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 10, 2032 Torisel injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 0 Class I among all firms' recalls; latest October 10, 2014
- FAERS reports
- 4,502 through July 30, 2026
What is temsirolimus used for?
From the label: indications and usageTORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
Source: FDA drug label (Torisel), 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
Is there a generic for temsirolimus (Torisel)?
The FDA approved the first generic temsirolimus on July 30, 2018. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists temsirolimus from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Torisel injection, the last expiring on November 10, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2018 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has temsirolimus been recalled?
The FDA's Enforcement Report lists 2 recalls naming temsirolimus since 2012: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 10, 2014 | Class III | Pfizer Inc. | Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. … |
| November 26, 2012 | Class III | Pfizer Inc. | Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the temsirolimus label say about other medicines?
The temsirolimus label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 17 other medicines name temsirolimus. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amlodipine | drug interactions | Angioedema with ACE inhibitors and Calcium Channel Blockers Angioedema has been reported in patients taking mammalian target of rapamycin (mTOR) inhibitors in combination with ramipril and/or amlodipine. |
| Atazanavir | warnings and precautions | Agents Inhibiting CYP3A Metabolism: Strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin may increase blood concentrations of the active metabolite sirolimus. |
| Carbamazepine | warnings and precautions | Inducers or Inhibitors of CYP3A Metabolism Agents Inducing CYP3A Metabolism: Strong inducers of CYP3A4/5 such as dexamethasone, carbamazepine, phenytoin, phenobarbital, rifampin, rifabutin, and rifampacin may decrease exposure of the active metabolite, sirolimus. |
| Clarithromycin | warnings and precautions | Agents Inhibiting CYP3A Metabolism: Strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin may increase blood concentrations of the active metabolite sirolimus. |
| Desipramine | drug interactions | Drug Interactions Effect of Temsirolimus on CYP2D6 or CYP3A The concentration of desipramine, a CYP2D6 substrate, was unaffected when 25 mg of temsirolimus was co-administered. |
| Dexamethasone | warnings and precautions | Inducers or Inhibitors of CYP3A Metabolism Agents Inducing CYP3A Metabolism: Strong inducers of CYP3A4/5 such as dexamethasone, carbamazepine, phenytoin, phenobarbital, rifampin, rifabutin, and rifampacin may decrease exposure of the active metabolite, sirolimus. |
| Diphenhydramine | warnings and precautions | At the discretion of the physician, treatment may be resumed with the administration of an H 1 -receptor antagonist (such as diphenhydramine), if not previously administered [see Dosage and Administration (2.2) ], and/or an H 2 -receptor antagonist (such as intravenous famotidine 20 mg or intravenous ranitidine 50 mg) … |
| Famotidine | warnings and precautions | At the discretion of the physician, treatment may be resumed with the administration of an H 1 -receptor antagonist (such as diphenhydramine), if not previously administered [see Dosage and Administration (2.2) ], and/or an H 2 -receptor antagonist (such as intravenous famotidine 20 mg or intravenous ranitidine 50 mg) … |
| Itraconazole | warnings and precautions | Agents Inhibiting CYP3A Metabolism: Strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin may increase blood concentrations of the active metabolite sirolimus. |
| Ketoconazole | drug interactions | Agents Inhibiting CYP3A Metabolism Co-administration of TORISEL with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus C max or AUC; however, sirolimus AUC increased 3.1-fold, and C max increased 2.2-fold compared to TORISEL alone. |
| Nefazodone | warnings and precautions | Agents Inhibiting CYP3A Metabolism: Strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin may increase blood concentrations of the active metabolite sirolimus. |
| Nelfinavir | warnings and precautions | Agents Inhibiting CYP3A Metabolism: Strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin may increase blood concentrations of the active metabolite sirolimus. |
| Phenobarbital | warnings and precautions | Inducers or Inhibitors of CYP3A Metabolism Agents Inducing CYP3A Metabolism: Strong inducers of CYP3A4/5 such as dexamethasone, carbamazepine, phenytoin, phenobarbital, rifampin, rifabutin, and rifampacin may decrease exposure of the active metabolite, sirolimus. |
| Phenytoin | warnings and precautions | Inducers or Inhibitors of CYP3A Metabolism Agents Inducing CYP3A Metabolism: Strong inducers of CYP3A4/5 such as dexamethasone, carbamazepine, phenytoin, phenobarbital, rifampin, rifabutin, and rifampacin may decrease exposure of the active metabolite, sirolimus. |
Every other medicine the temsirolimus label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ramipril | drug interactions | … mammalian target of rapamycin (mTOR) inhibitors in combination with ramipril and/or amlodipine. |
| Ranitidine | warnings and precautions | … -receptor antagonist (such as intravenous famotidine 20 mg or intravenous ranitidine 50 mg) approximately 30 minutes before restarting the TORISEL infusion. |
| Rifabutin | warnings and precautions | … dexamethasone, carbamazepine, phenytoin, phenobarbital, rifampin, rifabutin, and rifampacin may decrease exposure of the active metabolite, sirolimus. |
| Rifampin | drug interactions | Agents Inducing CYP3A Metabolism Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus C max (maximum concentration) and AUC (area under the … |
| Ritonavir | warnings and precautions | … clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin may increase blood concentrations of the active metabolite sirolimus. |
| Sirolimus | drug interactions | Agents Inducing CYP3A Metabolism Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus C max (maximum concentration) and AUC (area under the … |
| Sunitinib | warnings and precautions | Concomitant use of TORISEL with sunitinib The combination of TORISEL and sunitinib resulted in dose-limiting toxicity. |
Other labels that name temsirolimus
Source: FDA drug label (Torisel), 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 for temsirolimus?
The FDA Adverse Event Reporting System holds 4,502 reports that list temsirolimus among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Temsirolimus side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other