Norethindrone Acetate
Norethindrone acetate (Aygestin) is a progestin, a man-made version of the hormone progesterone. It's used to balance out hormone levels to treat absent menstrual bleeding (periods) and abnormal vaginal bleeding in adults. Norethindrone acetate (Aygestin) can also help with endometriosis. The dosage can differ depending on what condition you have, but norethindrone acetate (Aygestin) is usually taken by mouth once a day. Side effects include breakthrough bleeding and headaches. Brand name Aygestin has been discontinued and norethindrone acetate is only available as a generic.
What is Norethindrone acetate (Aygestin)?
What is Norethindrone acetate (Aygestin) used for?
- Lack of menstrual periods due to hormonal imbalance (secondary amenorrhea)
- Abnormal vaginal bleeding due to hormonal imbalance
- Endometriosis
How Norethindrone acetate (Aygestin) works
Norethindrone acetate (Aygestin) is a progestin, which is a man-made form of the natural sex hormone progesterone. It regulates the lining of your uterus (endometrium), which then helps manage your period.
In endometriosis, abnormal endometrial tissue outside your uterus acts like the normal tissue inside your uterus. This causes pain as it grows and sheds during your menstrual cycle. Since norethindrone acetate (Aygestin) regulates your endometrium, it can help ease endometriosis-related pain.
Drug facts
Side effects of Norethindrone acetate (Aygestin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Breakthrough bleeding or spotting
- Change in menstrual flow
- Lack of periods
- Headache or migraine
- Breast enlargement
- Breast tenderness
- Nausea
- Vomiting
- Stomach cramps or bloating
- Patches of darkened skin (melasma or chloasma)
- Acne
- Hair loss
- Yellowing of the skin or whites of eyes (jaundice)
- Trouble sleeping (insomnia)
- Changes in vision
Less Common Side Effects
- Changes in vaginal discharge
- Mood swings
- Depression
- Swelling in the hands, feet, or ankles
- Changes in weight
Norethindrone acetate (Aygestin) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Heart attack: chest pain or tightness; pain that spreads along to your shoulder, arm, neck, or jaw
- Stroke: sudden trouble talking or walking; numbness on one side of your body or face; shortness of breath; sudden, severe headaches
- Deep vein thrombosis (blood clot in the leg): swelling, pain, muscle tightness, leg cramp
- Pulmonary embolism (blood clot in the lung): cough, chest pain, trouble breathing, racing heart
The following Norethindrone acetate (Aygestin) side effects have also been reported
Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.
The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.
Get emergency help immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
More common
Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods)
symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst)
Rare
For megestrol—During chronic treatment
Backache
dizziness
filling or rounding out of the face
irritability
mental depression
nausea or vomiting
unusual decrease in sexual desire or ability in men
unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abdominal pain or cramping
bloating or swelling of ankles or feet
blood pressure increase (mild)
dizziness
drowsiness (progesterone only)
headache (mild)
mood changes
nervousness
pain or irritation at place of injection site
swelling of face, ankles, or feet
unusual or rapid weight gain
Less common
breast pain or tenderness
brown spots on exposed skin, possibly long-lasting
loss or gain of body, facial, or scalp hair
loss of sexual desire
trouble in sleeping
Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.
After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:
Delayed return to fertility
stopping of menstrual periods
unusual menstrual bleeding (continuing)
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Norethindrone acetate (Aygestin)
Pros
- Taken by mouth
- Helps to regulate your period from hormonal imbalances
- Available as a lower-cost, generic medication
Cons
- Not recommended if you have liver problems
- Can cause breakthrough bleeding and other bothersome side effects
- Not for those who have reached menopause
Pharmacist tips for Norethindrone acetate (Aygestin)
- Take norethindrone acetate (Aygestin) exactly as instructed by your healthcare professional. Your dosing schedule can be different depending on the reason you're taking the medication.
- You can take norethindrone acetate (Aygestin) with or without food. If it causes you to feel nauseous, taking it with a small meal might help.
- You might see some breakthrough bleeding or spotting while taking norethindrone acetate (Aygestin). This is normal, but let your prescriber know if it becomes too bothersome to see if you should stop the medication.
- Since there are many side effects and long-term risks linked to using norethindrone acetate (Aygestin), talk to your prescriber regularly about how the medication is working for you. They'll make sure you're taking the lowest dose possible for the shortest amount of time.
- If you have conditions causing low thyroid hormone levels, norethindrone acetate (Aygestin) can affect the results of your thyroid blood tests. Your prescriber might raise your dose of your thyroid medication (e.g., levothyroxine) to make up for this effect.
- If you've been sexually active and you miss your period or have other signs of pregnancy while taking norethindrone acetate (Aygestin), take a pregnancy test or call your prescriber. This medication shouldn't be used during pregnancy because it can potentially cause harm to unborn babies.
Common questions about Norethindrone acetate (Aygestin)
People taking norethindrone acetate (Aygestin) have reported both weight gain and weight loss, but it's unclear whether the changes in body weight are caused by norethindrone acetate (Aygestin) or other factors. If you do gain weight while taking this medication, it's likely due to water weight because this medication might cause your body to hold on to more water. Talk to your primary care provider if you're concerned about how norethindrone acetate (Aygestin) might affect your weight.
If you're taking norethindrone acetate (Aygestin) to treat secondary amenorrhea or abnormal vaginal bleeding, your healthcare team will ask you to take norethindrone acetate (Aygestin) daily for 5 to 10 days, then stop. Withdrawal bleeding typically happens within 3 to 7 days after stopping norethindrone acetate (Aygestin).
Depending on what medical condition you're taking norethindrone acetate (Aygestin) to treat, your healthcare team might instruct you to continue taking it during your period. For example, norethindrone acetate (Aygestin) is taken daily for endometriosis, but only for 5 to 10 days at a time for secondary amenorrhea or abnormal vaginal bleeding. Follow your prescriber's instructions carefully regarding when to take norethindrone acetate (Aygestin).
Acne is a potential side effect of progestins, including norethindrone acetate (Aygestin). This is because it has properties similar to sex hormones called androgens that can lead to oily skin and acne. If you notice skin changes like acne, let your prescriber know.
For irregular periods, you'll need to take norethindrone acetate (Aygestin) for 5 to 10 days to raise the activity in your uterine lining. For endometriosis, you'll need to take norethindrone acetate (Aygestin) for up to 6 to 9 months. Discuss how long you should take this medication with your prescriber.
Norethindrone acetate (Aygestin) on its own isn't FDA-approved to treat fibroids, or noncancerous growths in the uterus. But, there are combination medications that contain norethindrone acetate that are approved to treat fibroids, such as Myfembree and Oriahnn.
Norethindrone acetate (Aygestin) and medroxyprogesterone (Provera) are two progestins taken by mouth to treat irregular menstrual periods, but they have some differences. One difference is that norethindrone acetate (Aygestin) is FDA-approved to treat endometriosis, while medroxyprogesterone (Provera) isn't. On the other hand, medroxyprogesterone (Provera) is FDA-approved to protect the uterus in postmenopausal women who are taking estrogen medications, but norethindrone acetate (Aygestin) isn't approved for this use. Follow up with your healthcare professional to learn about more differences between these two medications.
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Risks and warnings for Norethindrone acetate (Aygestin)
Norethindrone acetate (Aygestin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of blood clots, heart attack, and stroke
- Risk factors: Personal or family history of blood clots | High blood pressure | Diabetes | High cholesterol | Smoking | Identified as obese | Lupus
Norethindrone acetate (Aygestin) can raise your risk of blood clots, which can be very dangerous. These blood clots can travel anywhere in your body and block blood flow, including your legs or arms (deep vein thrombosis, DVT) and your lungs (pulmonary embolism, PE). They can also travel to your heart, which can lead to a heart attack, or your brain, which can lead to a stroke. You're more likely to develop blood clots if you smoke tobacco, have a large body size, have certain medical conditions (e.g., high blood pressure, diabetes), or if you or your family have had blood clots in the past.
Let your prescriber know if you have pain or swelling in your legs or arms, as this can be a sign of a blood clot. Call 911 and get medical help right away if you have trouble breathing, chest or arm pain, facial drooping, weakness on one side of the body, severe headaches, or sudden changes in your speech or vision, since these can be signs of life-threatening complications of blood clots.
Abnormal changes in vision
Norethindrone acetate (Aygestin) can cause sudden changes in vision, including double vision and partial or complete vision loss. If you experience any of these vision changes, tell your prescriber or eye specialist right away. You'll need to get your eyes checked to see if you need to stop the medication.
Fluid build-up (edema)
- Risk factors: History of seizures | History of migraines | Heart problems | Kidney problems
Norethindrone acetate (Aygestin) can cause your body to hold onto more fluids. This can lead to stretched skin or swelling of your hands, feet, ankles, or stomach. If you have a seizure condition, migraines, or heart or kidney problems, fluid build-up can worsen your health condition. Contact your prescriber if you notice any swelling or puffiness in your extremities or worsening of your health conditions.
Depression
- Risk factors: History of depression
Norethindrone acetate (Aygestin) can worsen symptoms of depression if you have a history of depression. Symptoms include feeling sad or hopeless, losing interest in activities that once made you happy, changes in appetite, fatigue, trouble sleeping, and feeling worthless. Let your prescriber know if you've had depression in the past before starting norethindrone acetate (Aygestin). Contact your care team if you or anyone around you notice any changes in your thoughts or behavior.
Changes in blood sugar and cholesterol levels
- Risk factors: Diabetes | High cholesterol
Norethindrone acetate (Aygestin) can affect blood sugar levels. Let your prescriber know if you have diabetes before you start norethindrone acetate (Aygestin). They might have you monitor your blood sugar levels more often, or they might make changes to your diabetes medications.
Norethindrone acetate (Aygestin) can also raise your cholesterol levels, especially if you already have or are taking medications for high cholesterol. Your prescriber might have you do blood tests more often while taking norethindrone acetate (Aygestin).
Harm to unborn baby
Norethindrone acetate (Aygestin) can cause harm to your unborn baby if it's taken during pregnancy. Don't take this medication if you're currently pregnant or think that you might be pregnant. Taking this medication during the first four months of pregnancy can raise your unborn baby's risk of birth defects. If you become pregnant while taking norethindrone acetate (Aygestin), let your prescriber know right away.
Norethindrone acetate (Aygestin) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 5mg | 30 tablets | $18.52 | $0.62 |
Typical dosage for Norethindrone acetate (Aygestin)
- Lack of menstrual periods or abnormal vaginal bleeding: The typical dose is 2.5 mg to 10 mg by mouth once daily for 5 to 10 days.
- Endometriosis: The typical starting dose is 5 mg by mouth once daily for 2 weeks. Your healthcare team might raise your daily dose by 2.5 mg every 2 weeks until you reach a maintenance dose of 15 mg per day. Treatment might last for 6 to 9 months.
Interactions between Norethindrone acetate (Aygestin) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
- Boceprevir
- Dofetilide
- Tranexamic Acid
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Amobarbital
- Amoxicillin
- Ampicillin
- Amprenavir
- Apalutamide
- Aprepitant
- Aprobarbital
- Armodafinil
- Artemether
- Bacampicillin
- Betamethasone
- Bexarotene
- Bosentan
- Brigatinib
- Butabarbital
- Butalbital
- Carbamazepine
- Carbenicillin
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Clavulanic Acid
- Clobazam
- Cloxacillin
- Colesevelam
- Conivaptan
- Cyclacillin
- Cyclosporine
- Dabrafenib
- Darunavir
- Dexamethasone
- Dicloxacillin
- Doxycycline
- Efavirenz
- Elagolix
- Elvitegravir
- Encorafenib
- Enzalutamide
- Eslicarbazepine Acetate
- Eterobarb
- Etravirine
- Felbamate
- Fosamprenavir
- Fosaprepitant
- Fosnetupitant
- Fosphenytoin
- Griseofulvin
- Guar Gum
- Heptabarbital
- Hexobarbital
- Isotretinoin
- Ivosidenib
- Lesinurad
- Lixisenatide
- Lorlatinib
- Lumacaftor
- Mephobarbital
- Methohexital
- Minocycline
- Mitotane
- Modafinil
- Mycophenolate Mofetil
- Mycophenolic Acid
- Nafcillin
- Nelfinavir
- Netupitant
- Nevirapine
- Octreotide
- Oxacillin
- Oxcarbazepine
- Oxytetracycline
- Penicillin G
- Penicillin G Procaine
- Penicillin V
- Pentobarbital
- Phenobarbital
- Phenylbutazone
- Phenytoin
- Pitolisant
- Prednisone
- Primidone
- Red Clover
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Rufinamide
- Secobarbital
- St John's Wort
- Sugammadex
- Sultamicillin
- Tazemetostat
- Telaprevir
- Tetracycline
- Theophylline
- Thiopental
- Ticarcillin
- Tigecycline
- Tizanidine
- Topiramate
- Troglitazone
- Ulipristal
- Warfarin
How much does Norethindrone acetate (Aygestin) cost?
Norethindrone acetate (Aygestin) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Norethindrone acetate (Aygestin) will not be safe for you to take.
- Currently pregnant or think that you might be pregnant
- Undiagnosed vaginal bleeding
- Known, suspected, or history of breast cancer
- Active or history of blood clots
- Active or recent stroke or heart attack
- Liver damage or disease
- Using norethindrone acetate (Aygestin) to diagnose pregnancy
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