Prescription medicine
Toremifene Brand names: Fareston
Toremifene (Fareston) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $19.60 per toremifene citrate 60 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the toremifene FDA label on DailyMed (effective November 13, 2024, Kyowa Kirin, Inc.); the NDA 20497 record on Drugs@FDA; every toremifene label on DailyMed.
Highlights of the record
FDA label of November 13, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
QT PROLONGATION.
FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions (5.1) ]. WARNING: QT PROLONGATION FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions (5.1) ].
Used for
From the label: indications and usageFARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Forms and strengths
- 60 mg
Tablet.
On the market
- Earliest approval on file
- May 29, 1997 Fareston, Kyowa Kirin; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first December 4, 2018; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $19.60 per tablet Toremifene citrate 60 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 429 through July 30, 2026
What is toremifene used for?
From the label: indications and usageFARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Conditions named in the indications of toremifene's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen Agonist/Antagonist.
Source: FDA drug label (Fareston), Kyowa Kirin, Inc., effective November 13, 2024 (SPL set 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5), via openFDA; the full label on DailyMed
Is there a generic for toremifene (Fareston)?
The FDA approved the first generic toremifene on December 4, 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 toremifene from 2 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.
- 1997 earliest approval on file
- 2018 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for toremifene (Fareston)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $19.60 per Toremifene citrate 60 mg tablet, down 20% from $24.43 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Toremifene citrate 60 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Toremifene citrate 60 mg tablet | Generic | $19.60 per tablet | $587.97 | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the toremifene label say about other medicines?
The toremifene label names 32 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name toremifene. 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 |
|---|---|---|
| Amiodarone | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); … |
| Amitriptyline | drug interactions | … antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron). |
| Atazanavir | drug interactions | The administration of FARESTON with agents that are strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) increase the steady-state concentration in serum and should be avoided. |
| Carbamazepine | drug interactions | Inducers on Toremifene Strong CYP3A4 enzyme inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital, St. John's Wort, lower the steady-state concentration of toremifene in serum. |
| Clarithromycin | drug interactions | … haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron). |
| Dexamethasone | drug interactions | Inducers on Toremifene Strong CYP3A4 enzyme inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital, St. John's Wort, lower the steady-state concentration of toremifene in serum. |
| Disopyramide | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); … |
| Dofetilide | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); … |
| Erythromycin | drug interactions | … thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron). |
| Granisetron | drug interactions | … (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron). |
| Haloperidol | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); … |
| Ibutilide | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); … |
| Itraconazole | drug interactions | The administration of FARESTON with agents that are strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) increase the steady-state concentration in serum and should be avoided. |
| Ketoconazole | drug interactions | Inhibitors on Toremifene In a study of 18 healthy subjects, 80 mg toremifene once daily coadministered with 200 mg of ketoconazole twice daily increased the toremifene Cmax and AUC by 1.4- and 2.9-fold, respectively. |
Every other medicine the toremifene label names
| Medicine named | Section | What the label says |
|---|---|---|
| Levofloxacin | drug interactions | … amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron). |
| Midazolam | drug interactions | Following coadministration on days 6 and 18 relevant increases in midazolam and α-hydroxymidazolam Cmax and AUC were not observed. |
| Nefazodone | drug interactions | … ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) increase the steady-state concentration in serum and … |
| Nelfinavir | drug interactions | … ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) increase the steady-state concentration in serum and … |
| Ofloxacin | drug interactions | … amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron). |
| Ondansetron | drug interactions | … clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron). |
| Phenobarbital | drug interactions | Inducers on Toremifene Strong CYP3A4 enzyme inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital, St. … |
| Phenytoin | drug interactions | … CYP2C9 substrates with a narrow therapeutic index such as warfarin or phenytoin with FARESTON should be used with caution and require careful monitoring. |
| Procainamide | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; … |
| Quinidine | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; … |
| Rifabutin | drug interactions | Inducers on Toremifene Strong CYP3A4 enzyme inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital, St. … |
| Rifampin | drug interactions | Inducers on Toremifene Strong CYP3A4 enzyme inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital, St. … |
| Ritonavir | drug interactions | … itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) increase the steady-state concentration in serum and should be … |
| Sotalol | drug interactions | Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; … |
| Thioridazine | drug interactions | … ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); … |
| Venlafaxine | drug interactions | … (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); … |
| Voriconazole | drug interactions | … nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) increase the steady-state concentration in serum and should be avoided. |
| Warfarin | drug interactions | … ( 7.4 ) CYP2C9 substrates with a narrow therapeutic index such as warfarin or phenytoin with FARESTON should be used with caution and require careful monitoring. |
Source: FDA drug label (Fareston), Kyowa Kirin, Inc., effective November 13, 2024 (SPL set 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5), via openFDA; the full label on DailyMed
What do FAERS reports show for toremifene?
The FDA Adverse Event Reporting System holds 429 reports that list toremifene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 157 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as toremifene?
18 other medicines are given the same way (oral) and in the same FDA class as toremifene or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Raloxifene | Breast cancer | 17 labelers | $0.223 per tablet 60 mg tablet | No current entry |
| Tamoxifen | Breast cancer | 10 labelers | $0.277 per tablet 20 mg tablet | No current entry |
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
| Exemestane | Breast cancer | 10 labelers | $0.748 per tablet 25 mg tablet | No current entry |
| Talazoparib | Breast cancer | none listed | n/a | No current entry |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as toremifene
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to toremifene
- 18 medicines for the same use
- Other estrogen agonist/antagonists
- the pharmacologic class, with prices and generics
- Toremifene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other