Product image of Grystella (Desogestrel) supplied by GNH India

Grystella

Active Ingredient:
Desogestrel
Origin:
EU

Grystella (Desogestrel)

Grystella is a prescription oral tablet containing the progestogen desogestrel as its sole active ingredient. Marketed in the European Union, it provides systemic hormonal contraception without estrogen. The tablet is taken by mouth once daily and is classified under ATC code G03AC09 as a hormonal contraceptive for preventing pregnancy. It is intended for women of reproductive age seeking an estrogen‑free and reliable birth‑control option throughout.

Manufacturer / TM Owner

Laboratorios León Farma, S.A.

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Indications & Clinical Uses

Grystella is indicated for the prevention of pregnancy in women of childbearing potential.

  • Primary use as a progestin‑only oral contraceptive taken daily to prevent ovulation and achieve reliable birth control.
  • Suitable for women who have contraindications to estrogen, such as a history of thromboembolic disorders or migraine with aura.
  • Can be incorporated into a standard 28‑day cycle schedule, with a tablet taken each day without a hormone‑free interval.
  • May be prescribed to help regulate menstrual bleeding patterns when hormonal contraception is otherwise indicated.
  • Provides a reversible, user‑controlled method of contraception that does not require injection or device placement.

Side Effects

Like other hormonal contraceptives, Grystella may cause side effects that vary in frequency and severity.

Common

  • Irregular vaginal bleeding or spotting, especially during the first few months.
  • Headache or mild migraine.
  • Nausea or mild gastrointestinal discomfort.
  • Breast tenderness or mild enlargement.

Serious

  • Deep vein thrombosis or pulmonary embolism (rare but serious).
  • Severe allergic reaction such as rash, swelling, or difficulty breathing.
  • Liver dysfunction indicated by jaundice or abnormal liver tests.

Precautions & Warnings

Before prescribing Grystella, healthcare providers assess several precautionary factors to ensure safe use.

  • History of thromboembolic disease, stroke, or myocardial infarction.
  • Known or suspected pregnancy, as the medication is not intended for use during pregnancy.
  • Unexplained vaginal bleeding or active liver disease.
  • Severe hypertension or uncontrolled high blood pressure.
  • Smoking in women over 35 years of age.
  • Breast cancer or estrogen‑sensitive tumors.
  • Use of certain medications that may reduce contraceptive effectiveness.

Avoid Interactions

Grystella can interact with other medicines, affecting its efficacy or safety profile.

Avoid

  • Concurrent use with strong enzyme inducers such as rifampicin, carbamazepine, phenytoin, or St. John’s wort, which may markedly reduce contraceptive effectiveness.
  • Use with medications known to increase the risk of thrombosis, such as hormonal replacement therapy containing estrogen.

Use with caution

  • Antifungal agents like ketoconazole that may increase desogestrel levels.
  • Certain antiretroviral drugs (e.g., protease inhibitors) that can alter hormone metabolism.
  • Herbal supplements that affect liver enzymes, including ginseng or green tea extracts.
  • Medications that cause nausea or vomiting, which may impair absorption of the tablet.

Frequently Asked Questions

Desogestrel, the active ingredient in Grystella, prevents pregnancy by inhibiting ovulation, thickening cervical mucus to block sperm entry, and altering the endometrial lining to reduce the likelihood of implantation.

Grystella is taken orally once daily at the same time each day, without a hormone‑free interval, to maintain consistent hormone levels and ensure contraceptive efficacy.

Smoking, especially in women over 35 years of age, increases the risk of cardiovascular events with hormonal contraceptives. Healthcare providers usually advise against using Grystella in this population.

Common side effects include irregular vaginal bleeding or spotting, headache, nausea, mild gastrointestinal discomfort, and breast tenderness.

Serious but rare risks include blood clots such as deep vein thrombosis or pulmonary embolism, severe allergic reactions, and liver dysfunction.

Rifampicin is a strong enzyme inducer that can lower desogestrel levels, potentially reducing contraceptive effectiveness. Additional non‑hormonal contraception is recommended during concurrent use.

Desogestrel is excreted in small amounts in breast milk. While many guidelines consider progestin‑only pills compatible with breastfeeding, a healthcare professional should evaluate individual circumstances.

Weight changes are not a typical side effect of desogestrel‑only pills, and most users do not experience significant weight gain while taking Grystella.

If a dose is missed, take it as soon as remembered unless it is close to the time of the next scheduled dose. In that case, skip the missed tablet and continue with the regular schedule; additional contraception may be needed for the next 7 days.

Fertility typically returns quickly after discontinuation, often within one to two menstrual cycles, though individual timing can vary.

No, Grystella provides contraception only and does not protect against sexually transmitted infections. Barrier methods such as condoms should be used for STI prevention.

Using multiple hormonal contraceptives is generally unnecessary and may increase side‑effect risk. Discuss any combination therapy with a healthcare provider before starting.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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