Letrozole
Ovulation induction (commonly first-line for PCOS)
Sold as Femara (generic letrozole)
An aromatase inhibitor taken as a short oral course early in the cycle to induce ovulation. Widely used off-label in fertility care and often preferred over clomiphene for ovulation induction in PCOS.
When it is given
A short course of tablets early in the menstrual cycle, on its own for timed intercourse or before an IUI, and sometimes alongside injectables in a low-stimulation IVF protocol.
What it actually costs
The national average price a US pharmacy pays to acquire this drug, published by CMS for every priced package. A wholesale floor, not a retail quote.
- Letrozole 2.5 MG TabletNDC 62135049190 · effective Aug 19, 2026$0.15/ ea
- Letrozole 2.5 MG TabletNDC 62135049130 · effective Aug 19, 2026$0.15/ ea
- Letrozole 2.5 MG TabletNDC 59651018030 · effective Aug 19, 2026$0.15/ ea
- Letrozole 2.5 MG TabletNDC 51991075990 · effective Aug 19, 2026$0.15/ ea
- Letrozole 2.5 MG TabletNDC 51991075933 · effective Aug 19, 2026$0.15/ ea
- Letrozole 2.5 MG TabletNDC 51991075910 · effective Aug 19, 2026$0.15/ ea
- Letrozole 2.5 MG TabletNDC 50268047615 · effective Aug 19, 2026$0.15/ ea
- Letrozole 2.5 MG TabletNDC 50268047611 · effective Aug 19, 2026$0.15/ ea
Source: CMS National Average Drug Acquisition Cost (NADAC) · as of Aug 19, 2026
Across a whole stimulation cycle, medication typically totals $3,000–$7,000, which is the number that matters for a budget. See the full cycle breakdown or how families pay for it.
What the prescribing information says
The current FDA structured product label, as published through openFDA and DailyMed. Excerpted verbatim, not summarised.
What the FDA label approves it for
1 INDICATIONS AND USAGE Letrozole tablet is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer ( 1.1 ) Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy ( 1.2 ) First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer ( 1.3 ) 1.1 Adjuvant Treatment of Early Breast Cancer Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. 1.2 Extended Adjuvant Treatment of Early Breast Cancer Letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival (DFS) in patients treated with letrozole tablets for a median of 60 months [see Clinical Studies ( 14.2 , 14.3 )] . 1.3 First and Second-Line Treatment of Advanced Breast Cancer Letrozole tab
Dosage and administration
2 DOSAGE AND ADMINISTRATION Letrozole tablets are taken orally without regard to meals ( 2 ): Recommended dose: 2.5.mg once daily ( 2.1 ) Patients with cirrhosis or severe hepatic impairment: 2.5 mg every other day ( 2.5 , 5.3 ) 2.1 Recommended Dose The recommended dose of letrozole tablet is one 2.5 mg tablet administered once a day, without regard to meals. 2.2 Use in Adjuvant Treatment of Early Breast Cancer In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. In both the adjuvant study and the post approval adjuvant study, median treatment duration was 5 years. Treatment should be discontinued at relapse [see Clinical Studies ( 14.1 )]. 2.3 Use in Extended Adjuvant Treatment of Early Breast Cancer In the extended adjuvant setting, the optimal treatment duration with letrozole tablet is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration for letrozole tablets was 60 months. Seventy-one percent (71%) of patients were treated for at least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment
Warnings and cautions
5 WARNINGS AND PRECAUTIONS Decreases in bone mineral density may occur. Consider bone mineral density monitoring ( 5.1 ) Increases in total cholesterol may occur. Consider cholesterol monitoring. ( 5.2 ) Fatigue, dizziness and somnolence may occur. Exercise caution when operating machinery ( 5.4 ) Embryo-Fetal Toxicity: Can cause fetal harm when administered to pregnant women. Obtain a pregnancy test in females of reproductive potential. Advise females of reproductive potential to use effective contraception ( 5.6 , 8.1 , 8.3 ) 5.1 Bone Effects Use of letrozole may cause decreases in bone mineral density (BMD). Consideration should be given to monitoring BMD. Results of a safety study to evaluate safety in the adjuvant setting comparing the effect on lumbar spine (L2-L4) BMD of adjuvant treatment with letrozole to that with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4.1% in the letrozole arm compared to a median increase of 0.3% in the tamoxifen arm (difference = 4.4%) ( P <0.0001) [see Adverse Reactions ( 6 )] . Updated results from the BMD substudy (MA-17B) in the extended adjuvant setting demonstrated that at 2 years patients receiving letrozole had a
Contraindications
4 CONTRAINDICATIONS Pregnancy: Letrozole can cause fetal harm [see Use in Specific Populations ( 8.1 )] . Pregnancy: Letrozole can cause fetal harm [see Use in Specific Populations ( 8.1 )] . Known hypersensitivity to the active substance, or to any of the excipients [see Adverse Reactions ( 6 )] . Known hypersensitivity to the active substance, or to any of the excipients [see Adverse Reactions ( 6 )] . Pregnancy ( 4 ) Known hypersensitivity to the active substance, or to any of the excipients ( 4 )
Label for Letrozole, source: openFDA structured product labels · as of Sep 5, 2026
What has been reported to the FDA
FAERS is a voluntary reporting system. A high count reflects how widely a drug is used and how often people report, not how dangerous it is, and a report is not proof the drug caused the event.
- fatigue 7,463
- nausea 5,528
- neutropenia 5,170
- diarrhoea 4,698
- malignant neoplasm progression 4,509
- arthralgia 3,968
Source: openFDA FAERS (drug adverse events) · as of Sep 5, 2026
About Letrozole
What is Letrozole used for in fertility treatment?
An aromatase inhibitor taken as a short oral course early in the cycle to induce ovulation. Widely used off-label in fertility care and often preferred over clomiphene for ovulation induction in PCOS. A short course of tablets early in the menstrual cycle, on its own for timed intercourse or before an IUI, and sometimes alongside injectables in a low-stimulation IVF protocol.
How is Letrozole given?
Oral. A short course of tablets early in the menstrual cycle, on its own for timed intercourse or before an IUI, and sometimes alongside injectables in a low-stimulation IVF protocol.
How much does Letrozole cost?
The national average price a US pharmacy pays to acquire it (CMS NADAC) is $0.15 per ea, effective Aug 19, 2026. That is a wholesale floor, not the cash price you are charged. Across a whole IVF cycle, stimulation medication typically totals $3,000 to $7,000.
Is Letrozole FDA-approved for fertility use?
Letrozole is FDA-approved for hormone-receptor-positive breast cancer, so the label below describes that use. Its fertility use is off-label and long-established: prescribing a drug off-label is legal and routine in reproductive medicine.
Other medications in a cycle
- Clomiphene citrateOvulation inductionOvulation induction
- Follitropin (FSH)Controlled ovarian stimulation for IVFOvarian stimulation
- Menotropins (hMG)Combined FSH and LH activity during stimulationOvarian stimulation
- Ganirelix acetateGnRH antagonist that blocks a premature LH surgePreventing early ovulation