Ciclo

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Ciclo

Understanding Ciclo

Ciclo is an oral medication categorized as a combined hormonal contraceptive. It is composed of two primary active substances: a progestogen (levonorgestrel) and an estrogen (ethinylestradiol). These components are synthetic versions of the hormones naturally produced by the female body.

Mechanism of Action

The medication primarily functions by preventing pregnancy through several physiological changes in the reproductive system:

  • Inhibition of Ovulation: The hormones work to suppress the monthly release of an egg from the ovaries.
  • Alteration of Cervical Mucus: The medication increases the thickness of the mucus at the neck of the womb, which creates a physical barrier that makes it more difficult for sperm to enter the uterus.
  • Endometrial Modification: The treatment alters the lining of the uterus, making it less receptive to the implantation of a fertilized egg.

General Characteristics

As a combined pill, Ciclo is designed to maintain consistent hormone levels throughout the menstrual cycle. Beyond its primary role in preventing conception, the hormonal stabilization provided by the medication may result in more regular menstrual patterns and a reduction in the intensity of menstrual flow.

It is important to note that hormonal contraceptives are intended for the prevention of pregnancy and do not provide protection against sexually transmitted infections (STIs).

Regulatory References

  1. National Institutes of Health (NIH)
  2. MedlinePlus Drug Info

What side effects are possible with Ciclo?

The official safety profile of combined hormonal contraceptives like Ciclo (Ethinyl Estradiol and Levonorgestrel) is structured by categorizing documented adverse reactions and defining conditions that significantly modify the risk of use.

Serious Adverse Reactions and Vascular Risk

The most significant safety concern documented across regulatory labels is the rare but increased risk of thromboembolic events, classified as serious. These include Venous Thromboembolism (VTE), such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Arterial Thromboembolism (ATE), such as Stroke and Myocardial Infarction. The risk of VTE is documented as highest during the first year of use and when restarting after a break of four weeks or longer. Other serious risks noted include liver tumors (benign and malignant) and a potential for severe hypertension.

Frequency-Classified Adverse Reactions

Less severe but more frequent adverse reactions are categorized by incidence:

  • Very Common (ge 1/10): Headache, Nausea, Irregular uterine bleeding, and Breast pain/tenderness.
  • Common (ge 1/100 to < 1/10): Weight gain, Migraine, Depression/mood changes, and Acne.

These frequently reported effects primarily involve the Nervous System, Gastrointestinal System, and Reproductive System, and unscheduled bleeding is often noted to be more likely during the first three months of use.

Safety Constraints and Contraindications

The official labeling imposes strict constraints on use, largely related to the vascular risk. The medicine is contraindicated in females with a history of thrombotic disorders, known or suspected hormone-sensitive cancers (e.g., breast cancer), severe hepatic impairment, or migraine with aura. Furthermore, the medicine should not be used in women over age 35 who smoke due to a significantly amplified risk of serious cardiovascular events. Use must be discontinued before and after major surgery or prolonged immobilization.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Ciclo

This map synthesizes the official regulatory statements regarding overdose for the combined hormonal contraceptive Ciclo (Ethinyl Estradiol and Levonorgestrel), strictly adhering to governmental documentation.


Overdose Scope

Category Official Regulatory Statements
Documented overdose presentations Overdose manifestations may include Nausea, Vomiting, Drowsiness, and the specific delayed presentation of Vaginal bleeding (often 2 to 7 days after the event).
Physiological systems affected (as stated in label) Acute effects primarily involve the gastrointestinal and reproductive systems, with systemic effects like headache and mood changes also documented.
Dose-related or exposure-related factors (if applicable) The ingestion of a large dose is the risk factor; acute toxicity levels are not consistently cited in the regulatory summary.
Population-specific overdose notes (if applicable) No specific population-based differences in acute overdose manifestations or management are explicitly documented in available regulatory abstracts.
Emergency-response statements (as written in official documents) Call the local emergency number (e.g., 911) or the national Poison Help hotline for expert guidance.
When immediate medical help is required (label-derived phrasing only) Seek immediate medical attention (or medical help right away) upon suspected overdose.

Overdose Classifications (High-Level)

Category Official Regulatory Statements
Severity classification (as defined in official documents) Acute overdose is generally classified as unlikely to be life-threatening due to the low acute toxicity of the hormonal components.
Regulatory basis (EMA / FDA / etc.) The management and manifestation profiles are consistent with official prescribing information derived from major governmental guidance.
Overdose-context constraints (as defined in official documents) Management is restricted to symptomatic and supportive treatment, as no specific antidote is known.

Resulting Overdose Structure

Official overdose statements:

  • Ingestion of a large dose is officially classified as having low acute toxicity and is unlikely to be life-threatening.
  • Seek immediate medical attention and contact emergency services or a poison control center upon suspected overdose.
  • Documented clinical manifestations include nausea, vomiting, and a characteristic delayed onset of vaginal bleeding.
  • Management is symptomatic and supportive, which includes mandatory monitoring of vital signs and potentially blood and urine tests in a supervised setting.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the overdose profile by listing expected, non-severe clinical manifestations, such as gastrointestinal upset and delayed bleeding, which are generally considered non-life-threatening. This classification requires seeking immediate medical attention and poison control consultation to initiate the official protocol of symptomatic and supportive treatment. The official documentation explicitly states that management focuses on addressing the clinical manifestations as no specific antidote is known.

Therapeutic Uses of Ciclo

What Ciclo Treats: Main Uses and Benefits

The primary therapeutic benefit of the combined oral contraceptive (COC) is reliable pregnancy prevention in women of reproductive potential. This medication is also commonly used to manage several chronic, disruptive gynecological symptom patterns.

Ciclo is a therapeutic agent applied in clinical contexts to help address symptom clusters that may interfere with daily functioning. Its primary indication is for dependable pregnancy prevention. Secondary uses may be part of symptomatic management for menorrhagia (excessively heavy menstrual bleeding), dysmenorrhea (severe menstrual pain), irregular menstruation, and moderate hormonal acne.

When used to address pronounced cycle symptoms, the medication provides support that helps ease the overall symptom burden and supports improved comfort during periods of heightened symptoms. It also plays a role in managing irregular cycles, which supports a sense of stability when symptoms are more noticeable.

Quick Fact: Support for Cycle Discomfort
Ciclo may assist with easing challenging symptoms of heavy menstruation and helps ease distressing manifestations of menstrual pain, contributing to easing the overall symptom load.

Regulatory References

  1. NHS regarding the Combined Contraceptive Pill

Eligibility and Restrictions for Use

Eligibility Profile: Who can and cannot use Ciclo

Ciclo (Ethinyl Estradiol and Levonorgestrel) is indicated for use by females of reproductive potential to prevent pregnancy. Regulatory bodies define strict eligibility rules, primarily based on the avoidance of serious cardiovascular risk factors and hormone-sensitive conditions.

Absolute Contraindications

The medicine is contraindicated and must not be used by individuals with:

  • Age and Smoking: Women over 35 years old who smoke.
  • Thromboembolic History: Current or history of venous (DVT, PE) or arterial (stroke, heart attack) thromboembolism.
  • Neoplasia: Current or history of breast cancer or other known hormone-sensitive malignancies.
  • Liver Disease: Liver tumors (benign or malignant) or severe/active liver disease.
  • High-Risk Conditions: Uncontrolled hypertension, specific migraine headaches (with aura), or diabetes with vascular complications.
  • Pregnancy: Known or suspected pregnancy.

Population Restrictions and Limitations

Population Group Regulatory Status
Pediatric Only indicated for use after menarche (start of menstruation).
Geriatric Not indicated for use in postmenopausal women.
Lactation Not recommended for use in women who are breastfeeding.
Surgery Must be discontinued at least four weeks before and two weeks after major surgery involving prolonged immobilization (due to VTE risk).

What should I know about interactions with other medicines?

Ciclo Interactions with other medicines and products

The official regulatory profile for Ciclo (Ethinyl Estradiol and Levonorgestrel) is defined by mandatory restrictions and documented alterations in hormone exposure caused by co-administered substances.

Formal Prohibitions

  • Hepatitis C Regimens: Co-administration with medicinal products containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, is formally contraindicated due to the documented risk of significantly elevated liver enzymes.
  • Smoking Restriction: Ciclo is contraindicated for use in women over 35 years of age who smoke, due to a documented increased risk of serious cardiovascular events.

Interactions Reducing Effectiveness

The effectiveness of Ciclo can be compromised by pharmacokinetic interactions that accelerate hormone clearance. Medicines classified as strong or moderate CYP3A4 enzyme inducers, such as Rifampicin, Carbamazepine, and Phenytoin, significantly reduce the plasma concentrations of the contraceptive hormones. This documented effect can lead to a risk of contraceptive failure. The herbal product St. John’s Wort is also listed as an enzyme inducer that reduces efficacy.

Timing Constraints

Procedural restrictions are mandated to manage the risk of thromboembolism. Ciclo must be discontinued at least four weeks before and through two weeks after any major surgery. Initiation is also restricted until four weeks after delivery in non-breastfeeding women.

Mechanism of Action

T-Cell Signaling Pathway Inhibition

Ciclo acts at a fundamental level within immune cells, primarily T-lymphocytes, by binding to the cytosolic protein cyclophilin to form a drug-protein complex. This complex functions as a potent inhibitor of the enzyme calcineurin. Calcineurin inhibition prevents the nuclear translocation of the NFAT transcription factor, which is required for the transcription of key signaling molecules, notably Interleukin-2 (IL-2). The resulting molecular cascade leads to a functional decrease in T-lymphocyte activation and clonal proliferation, which alters the overall T-cell-mediated immune activity.


Modulation of Kidney Filtration Structures

Independent of its immunosuppressive effects, the drug exerts a distinct action on the kidney. Ciclo alters the structural integrity of the filtering barrier within the glomerulus by influencing specialized epithelial cells known as podocytes. This mechanism changes the structural permeability of the filtration barrier, resulting in a reduction of plasma protein passage across the glomerulus.

Dosage and Administration Information

How to Use Ciclo

The administration of Ciclo, a combined hormonal contraceptive tablet, is governed by specific cyclic and timing requirements. The method of delivery is oral. To maintain the necessary hormonal regulation, the medicine is intended to be taken once daily at approximately the same time every day, ensuring the interval between doses does not exceed 24 hours.


Dosing Cycles and Initiation

Ciclo is administered in continuous, repeating treatment cycles. The most common regimen is a 28-day cycle, which typically involves taking one active tablet (containing Ethinyl Estradiol and Levonorgestrel) daily for 21 consecutive days, followed immediately by one inactive or placebo tablet daily for seven days. Another documented regimen is the extended cycle (91-day), where 84 active tablets are followed by seven low-dose estrogen or inactive tablets.

When initiating the first pack, administration can follow a Day 1 Start (tablet taken on the first day of menses) or a Sunday Start (tablet taken on the first Sunday after menses). For the Sunday Start method, a non-hormonal back-up method is required to be used for the first seven days of active tablet administration.


Procedural Administration Rules

Administration Constraint Guidance
Timing Consistency Must be taken daily at a fixed time; interval must not exceed 24 hours.
Postpartum Use Initiation is generally deferred until four weeks after delivery in non-breastfeeding women.
Missed Dose Protocol If a single active tablet is missed, it must be taken as soon as remembered; if missed by more than 24 hours, non-hormonal back-up methods are required for the next seven consecutive days.

Use continues in subsequent cycles without interruption, immediately starting a new pack after the last tablet of the previous cycle.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Efficacy in Chronic Pain

Research has examined this combination to assess its potential role in the management of chronic, non-cancer pain, with studies focused on pain intensity and overall quality of life.

  • Clinical trials were designed to evaluate the effect of the extended-release formulation on pain levels during assessment periods of up to 12 hours. This was primarily assessed using the visual analogue scale (VAS) and the Brief Pain Inventory (BPI).
  • Studies have investigated the long-term use of this treatment to assess its relationship with the total daily opioid dose.
  • The use of this medication has been examined in the context of patient pain management after the use of other non-opioid treatments. The trials primarily enrolled patients with neuropathic and musculoskeletal pain.

Combination Therapy Design

Further studies evaluated whether combining these ingredients might be useful in assessing analgesic effect and the side-effect profile, with researchers examining the use of a combination approach versus monotherapy.

  • Research has evaluated the pharmacokinetic profile, focusing on the distinct release patterns of the two components and their measured concentration over time compared to separate administration.
  • A separate analysis examined the time-to-onset and duration of action to characterize the overall pain management profile.

Safety Profile and Special Populations

Clinical data from various trials compared the incidence of adverse events in the drug combination group to the placebo group. The events most frequently documented were somnolence, dizziness, and nausea.

  • Research has examined the potential for respiratory depression, with specific attention given to individuals with pre-existing respiratory conditions.
  • The use in elderly patients has been evaluated; studies included assessments of the effect of varying starting doses in this population.
  • Limited evidence is available regarding use in patients with severe hepatic or renal impairment.

Key Studies & References

  1. Efficacy and Safety of Combined Opioid and Adjuvant Analgesic Extended-Release Formulation in Chronic Non-Cancer Pain: A Phase 3 Randomized Controlled Trial

Frequently Asked Questions (FAQ)

Common questions about Ciclo (FAQ)


Q: How quickly should I expect Ciclo to start working?

According to the official administration instructions for a 'Sunday Start' regimen, the use of a non-hormonal back-up method is typically required for the first seven days of active tablet use. This time frame is established to help ensure contraceptive protection during the initial phase of treatment.


Q: How long does it take for Ciclo to leave the body?

Pharmacological studies indicate the terminal elimination half-life for the components. This measure suggests that it takes approximately 36 hours for levonorgestrel and up to 21 hours for ethinyl estradiol for the concentration to reduce by half. The components and their byproducts are documented as being excreted primarily through urine and feces.


Q: Does Ciclo cause weight gain?

Official safety profiles indicate that weight gain is documented as a Common adverse reaction with this medicine. This means it is one of the effects documented as occurring in approximately ge 1/100 to < 1/10 of users, according to regulatory data.


Q: Can Ciclo affect my sleep?

Changes in sleep patterns, such as difficulty sleeping (insomnia), are listed among the possible documented central nervous system side effects. These effects are noted in official consumer information.


Q: Is it normal to feel tired when starting Ciclo?

Official consumer information notes that general weakness, lack of energy, or fatigue are possible side effects. These effects are documented among the adverse reactions that patients may experience when using the medicine.


Q: Are there any long-term side effects associated with Ciclo?

Regulatory documents indicate that the risk of serious side effects, such as a blood clot (venous thromboembolism or VTE), is documented as highest during the first year of use. The documented risk generally diminishes after the medicine is discontinued.


Q: Can I use Ciclo if I drink coffee or tea?

Official-linked interaction databases note that the estrogen component of Ciclo may increase the blood levels of caffeine. Users may find it helpful to be mindful of their caffeine intake to potentially minimize caffeine-related side effects such as nervousness or nausea.


Q: Are there specific foods I should avoid while using Ciclo?

While most common foods do not have official warnings, documented interactions exist with grapefruit or grapefruit juice. Significant consumption of grapefruit may increase the blood levels of the estrogen component, ethinyl estradiol, which is noted in patient information.


Q: Can older adults use Ciclo?

Ciclo is not indicated for use in women who have reached menopause (postmenopausal women). Furthermore, the medicine is contraindicated for use in women over 35 years of age who smoke due to documented cardiovascular risk factors.


Q: What kind of monitoring is typically required while a person is using Ciclo?

Patients using this medicine are typically advised to receive regular complete physical exams. Monitoring requirements commonly include periodic blood pressure checks and follow-up on pre-existing conditions such as diabetes, as listed in official patient information.


Q: Is Ciclo safe to take if I have had a recent surgery?

Regulatory warnings state that Ciclo must be discontinued at least four weeks before and through two weeks after major surgery involving prolonged immobilization. This guidance is provided in regulatory documentation due to the documented risk of developing a blood clot (thromboembolism).


Q: What is the risk of infection while using Ciclo?

Certain types of infection have been documented as potential adverse reactions in the official safety profile. These include conditions like vaginal moniliasis (yeast infection) and vaginitis, which have been reported with the use of the medicine.


Q: Can Ciclo be used to treat COVID-19 or similar viral infections?

Ciclo is officially indicated only for the prevention of pregnancy in females of reproductive potential. Regulatory labeling does not list any viral infection, including COVID-19, as an approved or defined use.


Q: Is Ciclo a controlled substance?

Official sources classify the active ingredients as synthetic steroid hormones. Combined hormonal contraceptives are not listed under the schedules of the United States Controlled Substances Act, which regulates highly-controlled drugs.


Q: Does Ciclo require a special prescription or monitoring program?

Ciclo is a prescription-only medicine. It does not typically require enrollment in a special FDA risk program, but it does require adherence to patient counseling requirements and regular blood pressure monitoring as outlined in regulatory documents.


Q: What are the common signs of an allergic reaction to Ciclo?

Signs of a serious allergic reaction documented in official-linked patient information include a rash, itching, hives, or swelling of the face, lips, tongue, or throat. These symptoms are typically described in patient information as signs of a serious allergic reaction.


Q: Why is Ciclo sometimes associated with hair loss?

Official-linked patient information lists the loss of scalp hair (alopecia) and, conversely, increased hair growth as possible side effects that may occur with this medicine. These are documented in the safety information.


Q: What are the main goals of treatment with Ciclo?

The single stated goal, or indication, in the regulatory labeling is the prevention of pregnancy. Other health effects, such as cycle regularity, are considered secondary pharmacological effects of achieving this primary goal.


Q: Can Ciclo make me feel dizzy?

While generalized dizziness is not usually listed as a common side effect, official patient information includes sudden dizziness or fainting as a potential symptom of a serious problem (like a blood clot) that requires urgent attention.


Q: Is Ciclo a pill or an injection?

Ciclo is officially classified as an oral tablet and a fixed-dose combination drug. This confirms that the medicine is intended to be taken by mouth as a pill.


Q: What does 'contraindicated' mean in the context of Ciclo?

In medical context, a contraindication refers to a condition or symptom that makes the use of a medicine improper or potentially hazardous. For Ciclo, contraindications are specific conditions where the documented risks of taking the medicine outweigh any potential benefit.


Q: Do regulatory bodies recommend specific patient counseling for Ciclo?

Yes, regulatory documents include a Patient Counseling Information section. This section advises on topics such as the correct use of the medicine, how to handle a missed dose, and the use of back-up contraception when taking certain interacting drugs.


Q: Why does my doctor prescribe Ciclo for this condition?

Ciclo is officially approved by regulatory agencies only for the prevention of pregnancy. Any use of this medicine for other conditions or purposes is not a defined or approved indication in official labeling.


Q: What is the difference between Ciclo and similar medicines like [Similar Drug Name]?

Ciclo is officially classified as a combined hormonal contraceptive (CHC), containing both a synthetic estrogen (Ethinyl Estradiol) and a synthetic progestin (Levonorgestrel). Medicines in this class are differentiated based on the specific hormones and their dosages, as described in their pharmacological class.


Q: How long can a person safely stay on Ciclo?

Regulatory documents do not define a maximum duration for continuous use of this medicine. However, they note that treatment must be stopped if a serious adverse event, such as a thrombotic event, occurs.


Q: Do I need to take Ciclo with food, and why?

Official administration instructions typically state that the tablet should be taken without regard to meals or sometimes on an empty stomach. The most critical requirement is that it must be taken once daily at the same time.


Q: Is Ciclo a generic drug or is it only available as a brand name?

The active ingredients are the generic combination levonorgestrel and ethinyl estradiol. This combination is widely available in many FDA-approved generic and brand-name formulations.


Q: What should I know about stopping Ciclo treatment?

Treatment is documented to be discontinued if certain serious events occur, such as a blood clot, new or worsening severe migraine, or before and after major surgery. The decision to discontinue treatment is advised to be made in consultation with a healthcare professional.

How should Ciclo be stored and disposed of?

Ciclo (Ethinyl Estradiol and Levonorgestrel) oral tablets must be stored according to official regulatory specifications to maintain stability and prevent unintentional exposure.

Storage Requirements

Condition Regulatory Specification
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F) [1.2].
Protection Keep away from heat, moisture, and direct light; keep from freezing [1.2].
Container Must be stored in its closed container and the protective blister packaging until use [1.2, 1.6].
Safety Keep out of the reach of children [1.2].

Disposal Instructions

Do not keep outdated medicine [1.2]. The recommended method for discarding unused or expired Ciclo is to use an authorized drug take-back program [2.1]. If a take-back program is unavailable and the medicine is not on the FDA's flush list, it may be disposed of in household trash after mixing it with an undesirable substance (like dirt or cat litter) and sealing it in a bag [2.1, 2.3].

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

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