Europe — EMA
Gracial (Desogestrel, Ethinylestradiol)
Gracial is a combined oral contraceptive tablet containing desogestrel and ethinylestradiol, used for reliable hormonal birth control.
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What is Desogestrel, Ethinylestradiol?
Gracial is a combined oral contraceptive tablet containing the synthetic hormones desogestrel and ethinylestradiol. Marketed in the European Union, it is available by prescription only. Each tablet provides a fixed dose of the two active ingredients to deliver hormonal contraception. Gracial belongs to the drug class of combined oral contraceptives and is taken orally once daily by women of reproductive age and is intended for reliable birth control.
What is Desogestrel, Ethinylestradiol used for?
Gracial is prescribed for hormonal contraception and is used to prevent unintended pregnancy.
- Taken as a single tablet each day for three weeks followed by a one‑week hormone‑free interval. - Provides continuous suppression of ovulation by inhibiting the luteinizing hormone (LH) and follicle‑stimulating hormone (FSH) surge. - Improves cycle regularity and can reduce menstrual‑related symptoms such as heavy bleeding. - May be used to manage moderate acne that improves with combined estrogen‑progestin therapy. - Can be part of a broader contraceptive plan that includes counseling on correct use and backup methods.
What are the side effects of Desogestrel, Ethinylestradiol?
The safety profile of Gracial includes both common, usually mild, side effects and rare, potentially serious adverse events.
Common: - Nausea or mild gastrointestinal upset, especially during the first cycles. - Breast tenderness or swelling that usually resolves within a few weeks. - Headache ranging from mild to moderate intensity. - Weight fluctuations, often due to water retention. - Mood changes, including irritability or mild depressive symptoms. - Irregular spotting or breakthrough bleeding, particularly in the initial months.
Serious: - Deep vein thrombosis (DVT) presenting as leg pain, swelling, or redness. - Pulmonary embolism, which may cause sudden shortness of breath and chest pain. - Ischemic stroke, characterized by sudden neurological deficits such as weakness or speech difficulty. - Myocardial infarction (heart attack) with chest discomfort, radiating arm pain, or nausea. - Severe allergic reaction (anaphylaxis) including hives, swelling of the face, and difficulty breathing.
What precautions apply to Desogestrel, Ethinylestradiol?
Before prescribing Gracial, clinicians should evaluate individual risk factors and counsel patients on safe use.
- History of thromboembolic disorders, cardiovascular disease, or uncontrolled hypertension. - Current or recent pregnancy, as combined oral contraceptives are contraindicated. - Smoking, especially in women over 35 years of age. - Migraine with aura or other neurologic conditions that increase stroke risk. - Liver disease, including severe hepatic impairment. - Breast cancer or other estrogen‑sensitive malignancies. - Use of medications that may reduce contraceptive efficacy (e.g., certain antibiotics, anticonvulsants).
What does Desogestrel, Ethinylestradiol interact with?
Gracial can interact with other medicines, affecting its effectiveness or increasing the risk of adverse events.
Avoid: - Selective serotonin reuptake inhibitors (SSRIs) that increase bleeding risk when combined with estrogen. - Antifungal agents such as ketoconazole that can raise hormone levels. - Strong enzyme inducers like rifampin, carbamazepine, phenytoin, and St. John’s wort, which may lower contraceptive efficacy.
Use with caution: - Antibiotics (e.g., tetracyclines, macrolides) that may slightly reduce hormone levels. - Antiretroviral drugs used in HIV therapy, which can affect hormone metabolism. - Herbal supplements, especially those containing phytoestrogens, that could alter contraceptive action.



