Hailey FE 1/20 Tablets
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy.It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Oral Contraceptive; Iron Supplement
Pharmacologic Class
Estrogen/Progestin Combination; Iron Salt
Pregnancy Category
Category X
FDA Approved
Feb 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hailey FE 1/20 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), and also includes iron pills. It works by preventing your body from releasing an egg (ovulation) and by changing your cervical mucus and uterine lining to make it harder for sperm to reach an egg or for a fertilized egg to implant. The iron pills help prevent or treat iron deficiency that can occur with menstrual bleeding.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from this medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take this medication at the same time every day.
You can take it with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication.
Important Information for Women Taking This Medication for Birth Control
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's instructions regarding the use of non-hormonal birth control methods.
Do not skip any doses, even if you do not have sexual intercourse frequently.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and contact your doctor for guidance. If you are unsure what to do, call your doctor.
What to Do If You Miss a Period
If you miss two consecutive periods, take a pregnancy test before starting a new cycle of this medication.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from light and moisture. Do not store it in a bathroom.
* Keep the medication in a dry place.
Missing a Dose
If you miss a dose, refer to the package insert for instructions or contact your doctor to determine the best course of action. If you are taking this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a certain period to prevent pregnancy.
To get the most benefit from this medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take this medication at the same time every day.
You can take it with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication.
Important Information for Women Taking This Medication for Birth Control
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's instructions regarding the use of non-hormonal birth control methods.
Do not skip any doses, even if you do not have sexual intercourse frequently.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and contact your doctor for guidance. If you are unsure what to do, call your doctor.
What to Do If You Miss a Period
If you miss two consecutive periods, take a pregnancy test before starting a new cycle of this medication.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from light and moisture. Do not store it in a bathroom.
* Keep the medication in a dry place.
Missing a Dose
If you miss a dose, refer to the package insert for instructions or contact your doctor to determine the best course of action. If you are taking this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a certain period to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
- Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
- Use a backup method of birth control (like condoms) if you miss pills, start a new pack late, or are taking medications that can reduce the effectiveness of birth control.
- Be aware that this medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
- Discuss any planned surgeries with your doctor, as you may need to stop the pill temporarily to reduce the risk of blood clots.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily at the same time each day for 28 consecutive days. The first 21 tablets contain active hormones (Ethinyl Estradiol 0.02 mg, Norethindrone 1 mg), and the last 7 tablets contain Ferrous Fumarate 75 mg (equivalent to 24.6 mg elemental iron).
Condition-Specific Dosing:
missedDose:
Refer to package insert for specific instructions based on number of missed pills and week in cycle. Generally, take missed pill as soon as remembered, then continue daily. May need backup contraception.
postpartum:
Initiate no earlier than 4 weeks postpartum in non-breastfeeding women due to increased risk of thromboembolism. In breastfeeding women, not recommended until weaning or at least 6 months postpartum.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Dosing is the same as adults once menstruation has begun and contraception is desired.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor for fluid retention and electrolyte imbalance. No specific dose adjustment guidelines.
Dialysis:
Considerations: Not specifically studied, but generally not recommended due to potential for fluid retention and cardiovascular risk.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Contraindicated due to impaired steroid metabolism.
Severe:
Contraindicated due to impaired steroid metabolism.
Pharmacology
Mechanism of Action
Hailey FE 1/20 works primarily by suppressing gonadotropins (Follicle-Stimulating Hormone and Luteinizing Hormone), which in turn inhibits ovulation. Additional contraceptive effects include changes in the cervical mucus (making it less permeable to sperm) and alterations in the endometrium (reducing the likelihood of implantation). The ferrous fumarate component provides iron supplementation to prevent or treat iron deficiency anemia, which can be associated with menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-90%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect:
Food may slightly decrease Cmax for norethindrone but does not significantly affect bioavailability. Ferrous fumarate absorption is enhanced by vitamin C and inhibited by certain foods (e.g., dairy, tea, coffee).
Distribution:
Vd:
Ethinyl Estradiol: ~2-4 L/kg; Norethindrone: ~4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin); Norethindrone: ~96-98% (to albumin and sex hormone-binding globulin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: 6-20 hours; Norethindrone: 5-14 hours
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4 L/hr/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50-80%) and Fecal (20-50%); Ferrous Fumarate: Primarily fecal (unabsorbed iron)
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive effect begins after 7 consecutive days of active pill use. Full protection typically achieved after the first full cycle.
PeakEffect:
Not applicable for contraceptive effect; refers to steady-state hormone levels.
DurationOfAction:
Daily dosing maintains contraceptive effect.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder, or between the shoulder blades
+ Yellow skin or eyes (jaundice)
+ Fever with chills
+ Bloating or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Depression or other mood changes
Breast changes, such as:
+ A lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Fluid retention, characterized by swelling, weight gain, or difficulty breathing
If you experience any of these symptoms, contact your doctor immediately.
Additional Side Effects:
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (avoid sun exposure and use sunscreen)
Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects:
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder, or between the shoulder blades
+ Yellow skin or eyes (jaundice)
+ Fever with chills
+ Bloating or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Depression or other mood changes
Breast changes, such as:
+ A lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Fluid retention, characterized by swelling, weight gain, or difficulty breathing
If you experience any of these symptoms, contact your doctor immediately.
Additional Side Effects:
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (avoid sun exposure and use sunscreen)
Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects:
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- ACHES: Abdominal pain (severe)
- ACHES: Chest pain (severe), shortness of breath, coughing up blood
- ACHES: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- ACHES: Eye problems (blurred vision, loss of vision)
- ACHES: Severe leg pain, swelling, or redness in calf or thigh
- Yellowing of skin or eyes (jaundice)
- Dark urine or light-colored stools
- Depressed mood or severe mood changes
- Lump in the breast
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
+ Chloasma (dark skin patches) or increased sensitivity to sunlight or radiation
Recent or current use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure safe treatment.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
+ Chloasma (dark skin patches) or increased sensitivity to sunlight or radiation
Recent or current use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure safe treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor. Additionally, this drug may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests, so inform all your healthcare providers and lab workers that you are taking this drug.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the need for additional non-hormonal birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity, and consult your doctor if you have questions.
Taking this medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use and when restarting hormone-based birth control after a break of 4 weeks or more.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. Additionally, there is conflicting evidence regarding the risk of breast cancer associated with long-term use of this medication. If you have questions or concerns, discuss them with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not yet had their first menstrual period.
If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor. Additionally, this drug may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests, so inform all your healthcare providers and lab workers that you are taking this drug.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the need for additional non-hormonal birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity, and consult your doctor if you have questions.
Taking this medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use and when restarting hormone-based birth control after a break of 4 weeks or more.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. Additionally, there is conflicting evidence regarding the risk of breast cancer associated with long-term use of this medication. If you have questions or concerns, discuss them with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not yet had their first menstrual period.
If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Dizziness
- Abdominal pain (especially with iron overdose)
- Drowsiness
- Withdrawal bleeding (in females)
What to Do:
Seek immediate medical attention. For iron overdose, specific treatments may be needed. For hormonal overdose, treatment is generally supportive. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir (used for Hepatitis C) - risk of ALT elevations
- Tranexamic acid (increased risk of thrombosis)
Major Interactions
- CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Barbiturates, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin, Modafinil, St. John's Wort) - may decrease contraceptive efficacy
- Certain HIV protease inhibitors (e.g., Nelfinavir, Ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine, Efavirenz) - may decrease or increase hormone levels
- Bosentan (may decrease contraceptive efficacy)
- Colesevelam (may decrease absorption of hormones)
- Lamotrigine (oral contraceptives may decrease lamotrigine levels, leading to loss of seizure control)
Moderate Interactions
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels
- Acetaminophen - may increase ethinyl estradiol levels
- Atorvastatin - may increase ethinyl estradiol levels
- Thyroid hormones (e.g., Levothyroxine) - oral contraceptives may increase thyroid-binding globulin, requiring increased thyroid hormone dose
- Cyclosporine - oral contraceptives may increase cyclosporine levels
- Theophylline - oral contraceptives may increase theophylline levels
- Prednisolone - oral contraceptives may increase prednisolone levels
- Warfarin/Coumarins - may alter anticoagulant effect (monitor INR)
- Iron absorption inhibitors (e.g., antacids, calcium supplements, proton pump inhibitors, H2 blockers, tetracyclines, fluoroquinolones, cholestyramine) - for ferrous fumarate component
Minor Interactions
- Antibiotics (e.g., Penicillins, Tetracyclines) - theoretical risk of reduced efficacy due to altered gut flora, but clinical significance is debated; backup method often advised.
- Grapefruit juice - may increase ethinyl estradiol levels
Monitoring
Baseline Monitoring
Complete medical history (including family history of VTE, stroke, MI)
Rationale: To identify contraindications and risk factors for cardiovascular events, especially thromboembolism.
Timing: Prior to initiation of therapy.
Blood pressure measurement
Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor.
Timing: Prior to initiation of therapy.
Physical examination (including breast and pelvic exam, Pap test)
Rationale: To rule out pregnancy, assess general health, and screen for gynecological conditions.
Timing: Prior to initiation of therapy (as per clinical guidelines).
Pregnancy test
Rationale: To ensure patient is not pregnant, as the drug is contraindicated in pregnancy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure measurement
Frequency: Annually, or more frequently if clinically indicated.
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate discontinuation or change in contraceptive method.
Weight
Frequency: Annually
Target: Maintain healthy weight
Action Threshold: Significant weight gain may increase cardiovascular risk.
Annual physical examination (including breast and pelvic exam, Pap test)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptom Monitoring
- Severe abdominal pain (ACHES: A)
- Severe chest pain, shortness of breath, coughing up blood (ACHES: C)
- Severe headaches, dizziness, weakness, numbness (ACHES: H)
- Eye problems (blurred vision, loss of vision) (ACHES: E)
- Severe leg pain, swelling, redness in calf or thigh (ACHES: S)
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- Lump in breast
- Unusual vaginal bleeding or spotting
Special Patient Groups
Pregnancy
Hailey FE 1/20 is contraindicated during pregnancy. There is no indication for use of oral contraceptives in pregnancy, and there is evidence of fetal harm (Category X).
Trimester-Specific Risks:
First Trimester:
Contraindicated. Exposure during early pregnancy has not been shown to increase the risk of birth defects.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Not recommended during breastfeeding. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant.
Infant Risk:
L4 (Potentially Hazardous). Small amounts of hormones pass into breast milk. Potential for adverse effects on infant (e.g., jaundice, breast enlargement) and reduction in milk supply. Non-hormonal methods or progestin-only methods are generally preferred during lactation.
Pediatric Use
Not indicated for use before menarche. Once menstruation has begun, dosing is the same as for adults. Safety and efficacy have been established in females of reproductive age.
Geriatric Use
Not indicated for use in postmenopausal women. Efficacy and safety have not been established in this population. Oral contraceptives are generally discontinued at menopause.
Clinical Information
Clinical Pearls
- Breakthrough bleeding and spotting are common, especially during the first few cycles, and usually decrease over time. If persistent or heavy, consult a healthcare provider.
- Missing pills, especially early or late in the cycle, increases the risk of pregnancy. Always refer to the package insert for specific missed pill instructions.
- Vomiting or severe diarrhea within 3-4 hours of taking an active pill may reduce its effectiveness; use backup contraception.
- The iron pills (ferrous fumarate) are taken during the last 7 days of the cycle (inactive pills) to help replenish iron stores and manage menstrual blood loss-related iron deficiency.
- Some medications (e.g., certain antibiotics, anticonvulsants, St. John's Wort) can reduce the effectiveness of oral contraceptives. Always inform your doctor and pharmacist about all medications and supplements you are taking.
Alternative Therapies
- Other combined oral contraceptives (different estrogen/progestin types or doses)
- Progestin-only pills (mini-pill)
- Contraceptive patch (Xulane)
- Vaginal ring (NuvaRing, Annovera)
- Contraceptive injection (Depo-Provera)
- Contraceptive implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Permanent contraception (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans, especially generics)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.