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Gracial 28

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Gracial 28

Gracial 28_EN

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Gracial 28

Property Description
Active ingredients Desogestrel, Ethinylestradiol
Form Oral tablet (Biphasic)
Pharmacological class Sex hormones and modulators of the genital system
Common use Contraception (Prevention of pregnancy)
Origin Synthetic steroidal compounds

What Type of Medicine is Gracial 28?

Gracial 28 is a combined oral contraceptive (COC), formally classified within the pharmacological group of Sex hormones and modulators of the genital system. It is a synthetic medication, meaning its active components are laboratory-derived steroidal compounds designed for systemic hormonal regulation.

This product is a combination product because it contains two distinct synthetic active ingredients: Desogestrel, a synthetic progestin, and Ethinylestradiol, a synthetic estrogen. This combination acts by suppressing the hormones necessary for ovulation. The medication is delivered as an oral tablet and is specifically a biphasic formulation. This biphasic characteristic, defined by the tablets containing two different ratios of these synthetic hormones during the active cycle, distinguishes it from monophasic pills.

What is the General Purpose of Gracial 28?

The principal purpose of Gracial 28 is to provide effective contraception, specifically the prevention of pregnancy, in women of childbearing age. Its general function is to establish a systemic hormonal environment that suppresses the essential reproductive processes required for conception.

This purpose is achieved through the coordinated actions of the combined synthetic hormones. Its primary components function as hormones that prevent ovulation. The combination regulates the reproductive cycle to prevent the monthly release of an egg, simultaneously altering the environment within the reproductive tract. This hormonal regulation acts as a comprehensive barrier, establishing the essential benefit of Gracial 28 as a means of controlling fertility.

Regulatory References

  1. National Library of Medicine (MedlinePlus)

What side effects are possible with Gracial 28?

Possible Side Effects and Safety Information

The safety profile of Gracial 28 is classified according to the frequency and type of effects observed in clinical use, organized into System-Organ Classes (SOCs). The profile is defined by two major categories: common, non-serious reactions and rare, but serious, vascular events.

Frequency-Classified Adverse Reactions

Adverse reactions are formally documented across several organ systems, with incidence ranging from very common to very rare.

  • Very Common Reactions: Include headache and intermenstrual bleeding or spotting, the latter of which is often observed during the initial cycles of therapy.
  • Common Reactions: Encompass effects like mood changes (including depressed mood), nervousness, nausea, abdominal pain, acne, breast tenderness, and weight gain.
  • Uncommon to Rare Reactions: These include hypertension, rash, chloasma (melasma), changes in libido, and hypersensitivity reactions.

Serious Adverse Reactions and Safety Constraints

The most clinically significant risks documented in regulatory sources are thromboembolic events, which are rare but severe. These events include deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke. Rare occurrences of hepatic tumors (benign and malignant) are also noted in the safety literature associated with long-term use.

Safety documents also list formal contraindications that restrict the use of Gracial 28. These include a personal history of thromboembolic disorders, severe hepatic disease, and specific types of migraine with aura.

Population-Specific Safety Note: An important constraint applies to women who smoke and are over 35 years of age, who are classified as having a significantly increased risk of serious cardiovascular adverse reactions.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Gracial 28 (Desogestrel and Ethinylestradiol) provides specific guidance regarding overdose. The most common documented clinical manifestations following acute ingestion may include gastrointestinal disturbances such as nausea and vomiting. A hormonal effect recognized in females is the occurrence of vaginal bleeding, often referred to as withdrawal bleeding, which is also noted as a potential manifestation in young girls following accidental ingestion.

The regulatory profile indicates that this medicine generally presents low acute toxicity. In cases of overdose, official statements confirm that no serious or life-threatening harmful effects have been reported. This finding, concerning the absence of severe outcomes, frames the low inherent risk associated with the acute ingestion of multiple tablets.

Despite this low toxicity classification, it is mandated to seek immediate medical attention for professional evaluation of any symptoms or persistent discomfort following an overdose. The official regulatory action defines management as strictly symptomatic and supportive treatment, as sources confirm that there is no specific antidote known for the active ingredients in Gracial 28. This approach ensures all clinical signs are managed promptly under professional care.

Therapeutic Uses of Gracial 28

What Gracial 28 Treats: Main Uses and Benefits

The primary use of this medication is to provide effective fertility control for women of childbearing age, a context of use commonly applied for routine fertility management. The therapeutic relevance of this medication extends beyond contraception to managing symptoms related to the menstrual cycle and hormone balance.

This medication generally provides supportive symptomatic relief in conditions involving severe or moderate menstrual pain (dysmenorrhea), excessive menstrual blood loss (menorrhagia), and irregular cycle patterns. Furthermore, it is applied in addressing hormone-sensitive dermatological manifestations like acne vulgaris and hirsutism (unwanted hair growth).

The benefit is centered on achieving stability and predictability in daily life, especially during symptomatic periods. It is utilized for conditions presenting with recurrent or episodic manifestations where additional symptomatic support is needed. By easing the overall burden of monthly discomfort, the medication may assist with maintaining functional stability when symptoms interfere with routine activities.

Quick Fact: Relief for Androgen-Related Symptoms

This medication may assist with promoting skin clarity and may support the easing of hormone-related acne and hirsutism, contributing to easing the overall symptom load related to androgen excess.

Regulatory References

  1. NIH MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Gracial 28 — Official Regulatory Information

Populations for whom use is allowed (as stated in label):

  • Women of childbearing age (post-menarche) who require contraception and who do not possess documented contraindications.

Populations for whom use is contraindicated:

  • Women over 35 years of age who smoke due to increased cardiovascular risk.
  • Individuals with a history of or current thromboembolic disorders (such as DVT or Pulmonary Embolism), cerebral vascular disease (stroke), or coronary artery disease (heart attack).
  • Patients with active liver disease, hepatic tumors (benign or malignant), or known or suspected estrogen-dependent cancers (e.g., breast cancer).
  • Women with migraine headaches with focal neurological symptoms or undiagnosed abnormal uterine bleeding.

Pregnancy and Lactation Eligibility Status:

  • Pregnancy: Contraindicated if pregnancy is known or suspected.
  • Lactation: Not recommended for breastfeeding women, as the medicine may decrease breast milk quantity and quality.

Age and Condition-Specific Eligibility Rules:

  • Pediatric Use: Not indicated for use before the start of menstruation (pre-menarche). Geriatric Use is not indicated for postmenopausal women.
  • Surgery: Use must be discontinued at least four weeks prior to and for two weeks following major surgery or any situation involving prolonged immobilization.

The regulatory profile defines who can and cannot use Gracial 28 by establishing specific absolute contraindications based on the patient's medical history and comorbidity status. The constraints primarily serve to exclude populations where the labeled risk for serious vascular events or malignancy outweighs the benefit of contraception, as documented in official prescribing information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Gracial 28 (ethinylestradiol and desogestrel) may interact with a range of medicines and herbal products, which can affect its effectiveness or increase the risk of side effects. It is essential to inform your doctor about all prescription and non-prescription medicines, supplements, and herbal products you are currently taking.

Medicines that may reduce the effectiveness of Gracial 28

Some medicines can decrease the blood levels of the contraceptive hormones, potentially leading to breakthrough bleeding or contraceptive failure. This is often due to the induction of liver enzymes. Examples include:

  • Certain medicines for epilepsy: Phenytoin, carbamazepine, phenobarbital, primidone, topiramate, and oxcarbazepine.
  • Certain antibiotics and antifungals: Rifampicin, griseofulvin.
  • Certain HIV/Hepatitis C medicines: Ritonavir, nevirapine, efavirenz.
  • Herbal products: St. John's wort (Hypericum perforatum).

If you take any of these medicines, you may need to use an additional non-hormonal contraceptive method (like condoms) while taking the interacting medicine and for a period after stopping it.

Medicines that may increase the risk of side effects

Gracial 28 may increase the blood concentrations of certain other medicines, such as ciclosporin or lamotrigine. The combination of Gracial 28 with certain antiviral regimens for Hepatitis C (containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir) is contraindicated due to the potential for significant liver enzyme (ALT) elevations.

Other interactions

  • Grapefruit juice may increase the levels of the hormones in your body, potentially increasing the risk of side effects.
  • Gracial 28 may affect the body's metabolism of certain vitamins and minerals, though this is usually minor.

Always consult your healthcare provider for personalized advice regarding drug and product interactions.

Mechanism of Action

️ How Gracial 28 Works — Mechanism of Action

The action of Gracial 28 (Desogestrel/Ethinylestradiol) is based on a coordinated dual mechanism: central suppression of the hormones controlling the reproductive cycle and the creation of peripheral physical barriers. The drug’s components act as agonists at the Estrogen (ER) and Progesterone (PR) receptors, engaging multiple pathways to produce the primary physiological change.

Central HPO Axis Suppression and Anovulation

This mechanism focuses on establishing strong negative feedback on the Hypothalamus-Pituitary-Ovarian (HPO) Axis through the sustained presence of synthetic steroids. The feedback limits the necessary pre-ovulatory surge of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH), directly resulting in the core physiological change of anovulation (inhibition of egg release).

️ Peripheral Barrier Creation in the Reproductive Tract

The progestin component, Desogestrel, exerts an effect on peripheral tissues, modulating the secretory activity of the cervical glandular epithelium and the structure of the endometrium. This creates two secondary physiological barriers: the cervical mucus becomes thicker and less permeable to sperm, and the uterine lining becomes less receptive.

Synergistic Dual-Component Mechanism

The two active ingredients act synergistically, where the estrogen stabilizes the suppression and supports the cycle, while the progestin delivers the central anti-ovulatory effect and the peripheral barrier action. The mechanism is dependent on maintaining a sustained, threshold concentration of both hormones; if the concentration falls below this level, the central inhibition may fail, potentially allowing 'escape ovulation'.

Dosage and Administration Information

How to Use Gracial 28

Gracial 28 is an oral contraceptive that is administered according to a strict, continuous cyclic regimen established in the official prescribing information. The medication is delivered as a 28-day supply of tablets, which are formulated as a biphasic product, meaning the active hormones are present in two different concentration ratios across the first 21 days of the cycle.

Official Administration Guidelines

Property Instruction/Rule
Route of Administration Oral (by mouth).
Dosing Schedule One tablet daily for 28 consecutive days, consisting of 21 active tablets followed by 7 inactive (placebo) tablets.
Timing & Consistency The tablet must be taken at the same time each day with no specific requirement to take it with or without food.
Sequential Intake Due to its biphasic nature, tablets must be taken in the specific, sequential order indicated on the blister packaging to follow the intended hormonal schedule.

Procedural and Population Rules

The official instructions detail specific conditions for starting the regimen and for certain patient groups. Initiation of the first pack may begin on the first day of the menstrual period (Day 1 start) or on the first Sunday after the period begins. For a Sunday start or a start later than Day 1, an additional, non-hormonal method of contraception must be used for the first seven days of the initial cycle. The standard adult dosing regimen is also used for postpubertal adolescents requiring contraception. The medication is contraindicated and not to be used in patients with chronic hepatocellular disease with abnormal liver function.

This continuous 28-day protocol requires a new pack to be started immediately after the completion of the prior one, ensuring no more than seven hormone-free days elapse.

Recent Clinical Evidence

Research Evidence / Overview of studies for Gracial 28

Evidence for Use in Contraception

The primary evidence base for combined oral contraceptives like this one is built on Randomized Controlled Trials (RCTs) and similar research. These studies were designed to evaluate the regimen in preventing pregnancy. Researchers monitored outcomes by tracking the Pearl Index, a statistical calculation of how many pregnancies occur per 100 women over one year of use. The study populations primarily included females of childbearing age and postpubertal adolescents.

Studies conducted for regulatory purposes described specific, observed calculations of the Pearl Index across the measured observation periods. This research provides insight into the patterns observed when the medication was used under specified trial conditions. While the body of evidence for contraception is large, long-term outcomes extending beyond several years of continuous use are mainly characterized by observational data rather than controlled trials.

Evidence for Menstrual Cycle Regulation

Research examined this regimen in clinical contexts involving outcomes such as menstrual discomfort (dysmenorrhea), volume of menstrual blood loss (menorrhagia), and cycle regularity patterns. The evidence here often comes from comparative trials and observational evaluations that monitored changes in patient-reported outcomes. Researchers measured outcomes related to systemic or functional imbalance, such as patient-reported pain scales and the use of pain medication.

Trials described patterns of change in patient-reported pain scales and medication usage during the measured cycles. Findings also described shifts in the frequency of spotting or breakthrough bleeding, providing context to cycle patterns. Controlled trials documenting sustained symptomatic effects for these conditions are limited.

Evidence for Androgen-Related Skin Symptoms

Research has observed this medication in studies involving females with androgen-related conditions, primarily acne vulgaris. The research foundation includes dedicated Randomized Controlled Trials (RCTs). Research examined outcomes related to dermatological manifestations, such as changes in the numerical count of acne lesions and assessments using physician-rated scales. Data describing the effect on hirsutism (unwanted hair growth) remains more limited compared to the data collected for acne.

Studies typically provide data for an intermediate period of six months; therefore, information regarding the sustained dermatological outcomes beyond this duration is not well characterized by controlled trials. Furthermore, data for certain groups remain insufficient, especially those with complex comorbidities, as these individuals are often excluded from the core regulatory trials. The findings describe group patterns, not personal outcomes, and research does not provide individual predictions.

Key Studies & References PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands Desogestrel/Ethinylestradiol Famy 150/20 and 150/30

Frequently Asked Questions (FAQ)

Common questions about Gracial 28 (FAQ)

Q: Can taking Gracial 28 affect my future ability to get pregnant?

A: Official information indicates that the return to normal fertility and menstrual cycles typically occurs shortly after stopping the use of combined oral contraceptives like Gracial 28. The medication's effect on suppressing ovulation is considered reversible. Concerns regarding fertility are best addressed by a healthcare professional.

Q: How long does it typically take to see the expected effects of Gracial 28?

A: Gracial 28 is intended to begin providing its hormonal effect immediately upon starting the first active pill. However, official guidance for those who do not start on Day 1 of their period recommends using an additional non-hormonal contraceptive method for the first seven days of the initial cycle. This waiting period is established to ensure the full contraceptive effect is reliably attained.

Q: What happens when I stop taking Gracial 28?

A: When Gracial 28 is discontinued, the hormonal suppression ends. The normal menstrual cycle and the potential for ovulation typically return shortly after cessation of the medication. This shift means the body will resume its natural hormone production and the possibility of pregnancy returns.

Q: Is it common to experience spotting or breakthrough bleeding on Gracial 28?

A: Yes, regulatory documents list spotting or bleeding between periods (known as intermenstrual bleeding) as a Very Common effect. This pattern is particularly observed during the first few cycles as the body adjusts to the new hormonal balance. If bleeding is persistent, heavy, or unusual, seeking review from a healthcare professional is appropriate.

Q: Can antibiotics make Gracial 28 less effective?

A: Only a specific group of antibiotics are documented in official regulatory sources as having the potential to reduce the effectiveness of the hormones in Gracial 28. These include medicines like Rifampicin and Griseofulvin. The potential for interactions between any medication, including antibiotics, and Gracial 28 should be reviewed with a healthcare professional.

Q: Does Gracial 28 affect blood pressure readings?

A: The use of combined oral contraceptives like Gracial 28 is documented to have the potential to cause an increase in blood pressure (hypertension) in some individuals, which is an Uncommon side effect. For this reason, regulatory guidance recommends that blood pressure should be periodically monitored during use.

Q: Does sun exposure or tanning interact with Gracial 28?

A: A documented side effect associated with hormonal contraceptives is chloasma (melasma), which causes patchy darkening of the skin. Official information suggests that women who are prone to chloasma should take protective measures and avoid excessive exposure to sun or ultraviolet (UV) radiation while using this medicine.

Q: How quickly does the effect of Gracial 28 wear off after stopping use?

A: The contraceptive effect of Gracial 28 ceases once the active tablets are stopped. Regulatory documents state that the return of normal ovulation and the potential for pregnancy typically occurs shortly after discontinuation of the medication.

Q: Does taking Gracial 28 affect the results of lab tests?

A: Yes, the estrogen component in Gracial 28 may affect the results of certain laboratory tests. These effects are documented in regulatory sources and can include changes to blood clotting factors, lipid profiles, and levels of certain binding proteins like sex hormone-binding globulin.

Q: Is Gracial 28 the same as other '28-day' pills?

A: Gracial 28 is a specific type of combined oral contraceptive that is distinct due to its biphasic formulation. This means the active tablets are designed to deliver two different ratios of the active hormones across the 21-day active phase, which differs from standard monophasic or triphasic pills.

Q: Can I use Gracial 28 if I have a history of migraines?

A: Gracial 28 is formally contraindicated (must not be used) if a person has a history of migraines with focal neurological symptoms (such as migraine with aura). General migraine history requires individual assessment by a healthcare professional to determine suitability for use.

Q: What is the difference between Gracial and other combination pills?

A: The primary difference lies in the formulation: Gracial 28 is a biphasic combined oral contraceptive. This design means the dosage of the active hormones changes once halfway through the active cycle, distinguishing it from monophasic pills that maintain a constant dosage.

Q: Will Gracial 28 cause weight gain for most people?

A: Regulatory documents list weight gain as a Common side effect associated with this medication. This classification indicates an observed pattern in trials (1–10% of users), but it is not expected to occur in the majority of users.

Q: Is there any research about Gracial 28 and acne improvement?

A: Yes, regulatory trial summaries describe research that has specifically examined outcomes related to dermatological manifestations in females. This includes studies focusing on acne vulgaris, where researchers monitored changes in the numerical count of acne lesions and other physician-rated assessments.

Q: Does Gracial 28 interact with any common foods or drinks?

A: Official regulatory information specifically documents that Grapefruit juice may potentially increase the blood levels of the medicine’s hormones. Any concerns regarding food and drink interactions are appropriately addressed by a healthcare professional.

Q: Are there generic versions of Gracial 28 available?

A: The active ingredients in Gracial 28 are desogestrel and ethinyl estradiol. Lower-cost generic versions containing these same active ingredients may be available by prescription, depending on the current status of the drug’s patent and local regulations.

Q: What should I do if I have unusual bleeding while on Gracial 28?

A: Official patient guidance notes that if you experience breakthrough bleeding or spotting that continues for more than one week, or if two periods are missed in a row, consulting a healthcare provider is generally necessary. This is a situation that warrants medical review.

Q: Is it normal to have a shorter or lighter period while using Gracial 28?

A: Yes, a change in the menstrual pattern, often resulting in a shorter or lighter withdrawal bleed, is an expected physiological effect. This is related to how the medication's hormonal components affect the uterine lining, and this pattern is documented in associated research.

Q: Are there common signs that Gracial 28 is not working as intended?

A: The regulatory guidance highlights that missed periods, or persistent or sudden heavy bleeding, are signs that are noted as situations that warrant medical evaluation.

Q: Is Gracial 28 used for any condition other than its main purpose?

A: The sole labeled indication for Gracial 28 in official regulatory documents is for contraception (the prevention of pregnancy). Although secondary effects on conditions like acne are noted in clinical research, the official approval is strictly for its contraceptive use.

Q: How is the efficacy of Gracial 28 described in research papers?

A: Regulatory documents describe the efficacy of this combined oral contraceptive using the Pearl Index, a statistical measure of pregnancy risk. The results typically indicate that the product is highly effective in preventing pregnancy when used perfectly as directed, as demonstrated in clinical trials.

Q: Do mood stabilizers or antidepressants interact with Gracial 28?

A: Regulatory guidance advises consulting a healthcare provider regarding interactions, as certain medicines that affect liver enzymes or that are used for mood disorders may potentially impact the blood concentrations of the contraceptive hormones. This is due to the way these medicines are processed by the body.

Q: Is Gracial 28 considered a low-dose hormonal treatment?

A: Gracial 28 is commonly classified as a low-dose combined oral contraceptive. This classification is based on the specific, low microgram dosage of ethinylestradiol (the estrogen component) contained within the active tablets.

Q: Can Gracial 28 affect cholesterol levels?

A: Yes, the use of combined oral contraceptives may affect the metabolism of fats in the body. Regulatory documents mention that blood cholesterol and triglyceride levels should be monitored for certain patients who may have risk factors for related conditions.

Q: Is it safe to drive or operate machinery while using Gracial 28?

A: Official regulatory information typically indicates that Gracial 28 is not expected to affect the ability to drive or operate machinery. If any concerns about side effects that could affect driving arise, seeking advice from a healthcare professional is appropriate.

Q: How long can a person safely use Gracial 28?

A: For individuals who are deemed low-risk and who do not have contraindications, regulatory information indicates that the benefits of combined oral contraceptives can outweigh the risks. The pill may be prescribed for long periods, potentially up to the age of menopause, provided the user is regularly monitored for changes in their risk profile.

How should Gracial 28 be stored and disposed of?

How to Store and Dispose of Gracial 28

Official regulatory information for Gracial 28 dictates specific storage and disposal requirements to maintain the product's stability and ensure proper environmental management.

Official Storage Conditions

Requirement Instructions
Temperature Store at controlled room temperature (typically 20 C to 25 C).
Protection Keep in the original blister and carton to protect from light and moisture.
Handling Do not freeze and avoid exposure to excessive heat above 30 C.
Safety Keep out of the sight and reach of children.

Disposal Requirements

Gracial 28 must be disposed of according to pharmaceutical waste guidelines. Do not dispose of this medicine in household trash or flush it down the toilet (wastewater). Unused or expired medication should be returned to a pharmacy or official collection point to prevent environmental contamination, as required by regulatory authorities.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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