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Letrozole Side Effects: Common, Severe, Long Term

While it is rare, people taking letrozole may develop a condition known as ovarian hyperstimulation syndrome (OHSS). It causes symptoms ranging from bloating and diarrhea to extreme shortness of breath and chest pains. Letrozole (Femara), when used for fertility, can stimulate ovulation in people with PCOS. Get the drug data and decision support you need, including TRUE Daily Updates™ including every day including weekends and holidays.

  • There were no effects on the reproductive performance of female offspring.
  • Also, androgens accumulation in the follicle may stimulate insulin-like growth factor 1 (IGF-1) and other endocrine and paracrine factors, which may synergize with FSH to promote folliculogenesis (19).
  • It’s important to discuss all your concerns with your doctor.
  • The effect of hepatic impairment on letrozole tablets exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.
  • However, in clinical studies the benefit of letrozole was not reduced when administered immediately after tamoxifen.

First and second-line treatment of advanced breast cancer

In the letrozole arm, 71% of the patients were treated for a least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment. After the unblinding of the study at a median follow-up of 28 months, approximately 60% of the selected patients in the placebo arm opted to switch to letrozole. Breast cancer patients with severe hepatic impairment are thus expected to be exposed to higher levels of letrozole than patients with normal liver function receiving similar doses of this drug see Dosage and Administration (2.5). Based on post-marketing reports, findings from animal studies and the mechanism of action, letrozole can cause fetal harm and is contraindicated for use in pregnant women.

In 2000, the first pilot study for the clinical use of letrozole for OI indicated a high rate of ovulation in polycystic ovary syndrome (PCOS) patients (4). In 2004, a study by Legro etal. in the New England Journal of Medicine showed that letrozole was a more effective medication for OI than clomiphene in women with PCOS. This suggested that letrozole may be a better choice as a first-line medication (5). From then on, the use of letrozole in infertility treatment has been greatly popularized, and the studies about its clinical effects and mechanisms of action continued.

Femara is usually taken once per day, or once every other day. Do not take this medicine in larger or smaller amounts or for longer than recommended. Tell your doctor about all other medicines you use, especially tamoxifen (Soltamox).

Letrozole dosing information

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during Femara therapy andfor at least 3 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy issuspected, during treatment with Femara see WARNINGS AND PRECAUTIONS and Use In Specific Populations. Selected baseline characteristics for thisstudy are shown in Table 11. In these instances, https://courses.iskconmangaluru.com/steroids-before-and-after-understanding-the-impact-31/ the highest single dose ingested was 62.5 mg or 25 tablets.While no serious adverse reactions were reported in these cases, because of the limited data available, no firm recommendations fortreatment can be made. In general, supportive care and frequent monitoring ofvital signs are also appropriate.

However, some of these phytoestrogens work to reduce estrogen levels and may be beneficial. Diana Gariglio-Clelland, RD, CDCES, is a registered dietitian and certified diabetes care and education specialist with expertise in medical nutrition therapy, diabetes management, and weight-neutral nutrition counseling. While using Femara, you may need frequent medical tests and your bone mineral density may also need to be checked.

Administration of 0.3 mg/kg/day resulted in AUC values that were similar to theAUC in adult patients receiving the recommended dose of 2.5 mg/day. Decreased fertility was accompanied by hypertrophy of thehypophysis and testicular changes that included degeneration of the seminiferous tubular epithelium and atrophy of the femalereproductive tract. Young rats in this study were allowed to recover following discontinuation of letrozole treatment for 42 days.Histopathological changes were not reversible at clinically relevant exposures. Administration of 0.3 mg/kg/day resulted in AUC values that were similar to the AUC in adult patients receiving the recommended dose of 2.5 mg/day. Decreased fertility was accompanied by hypertrophy of the hypophysis and testicular changes that included degeneration of the seminiferous tubular epithelium and atrophy of the female reproductive tract.