Prescription medicine
Thiotepa Brand names: Tepadina
Thiotepa (Tepadina) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 7 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the thiotepa FDA label on DailyMed (effective January 30, 2026, Amneal Pharmaceuticals LLC); the NDA 11683 record on Drugs@FDA; every thiotepa label on DailyMed.
Highlights of the record
FDA label of January 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SEVERE MYELOSUPPRESSION and CARCINOGENICITY TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of TEPADINA [see Warnings and Precautions (5.1) ] TEPADINA should be considered potentially carcinogenic in humans [see Warnings and Precautions (5.7) ] WARNING: SEVERE MYELOSUPPRESSION and CARCINOGENICITY See full prescribing information for complete boxed warning. May cause severe marrow suppression or ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. (5.1) Potentially carcinogenic in humans.
Used for
From the label: indications and usageTEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia.
Forms and strengths
- 15 mg
- 100 mg
- 200 mg
- 400 mg
- 15 mg/1.5ml
Injection (powder) (lyophilized) for solution; injection (powder) for solution.
On the market
- Earliest approval on file
- March 9, 1959 Thiotepa, Immunex; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first April 2, 2001; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 16, 2041 Tepylute 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)
- 0 since 2012 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 9,494 through July 30, 2026
What is thiotepa used for?
From the label: indications and usageTEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1 , 14) For treatment of adenocarcinoma of the breast or ovary. (1.2) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatment of superficial papillary carcinoma of the urinary bladder. […]
Conditions named in the indications of thiotepa's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (TEPADINA), NDA208264 (Adienne Sa), as published by Amneal Pharmaceuticals LLC, effective January 30, 2026 (SPL set 559e353c-2dc0-16ba-e054-00144ff8d46c), via openFDA; the full label on DailyMed
Is there a generic for thiotepa (Tepadina)?
The FDA approved the first generic thiotepa on April 2, 2001. 12 generic applications are approved; 9 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 thiotepa from 7 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 no patent for Thiotepa injection; a patent listed only for Tepylute injection runs to August 16, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1959 earliest approval on file
- 2001 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has thiotepa been recalled?
The FDA's Enforcement Report lists 1 recall naming thiotepa since 2012: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of thiotepa and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 21, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the thiotepa label say about other medicines?
The thiotepa label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name thiotepa. 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 |
|---|---|---|
| Busulfan | warnings and precautions | Hepatic veno-occlusive disease may occur in patients who have received high-dose TEPADINA in conjunction with busulfan and cyclophosphamide [ see Adverse Reactions (6.1) ]. |
| Clarithromycin | drug interactions | Avoid co-administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with TEPADINA due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 ) ]. |
| Cyclophosphamide | drug interactions | The administration of thiotepa with cyclophosphamide in patients reduces the conversion of cyclophosphamide to the active metabolite, 4-hydroxycyclophosphamide; the effect appears sequence dependent with a greater reduction in the conversion to 4-hydroxycyclophosphamide when thiotepa is administered 1.5 hours prior to … |
| Itraconazole | drug interactions | Avoid co-administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with TEPADINA due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 ) ]. |
| Phenytoin | drug interactions | Avoid co-administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with TEPADINA due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 ) ]. |
| Rifampin | drug interactions | Avoid co-administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with TEPADINA due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 ) ]. |
| Ritonavir | drug interactions | Avoid co-administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with TEPADINA due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 ) ]. |
Other labels that name thiotepa
Source: FDA drug label (TEPADINA), NDA208264 (Adienne Sa), as published by Amneal Pharmaceuticals LLC, effective January 30, 2026 (SPL set 559e353c-2dc0-16ba-e054-00144ff8d46c), via openFDA; the full label on DailyMed
What do FAERS reports show for thiotepa?
The FDA Adverse Event Reporting System holds 9,494 reports that list thiotepa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,672 are coded as a death and 1,813 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?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Thiotepa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other