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Angeliq: Uses, Side Effects and Dosage

Status:
Prescription (Rx) Boxed warning Facts
Strength:
1 mg, 0.5 mg, 0.5 mg, 0.25 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Angeliq

What is the most important information I should know about Angeliq (a combination of estrogen and progestogen)?

  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (declines of brain function).
  • Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with progestogen may increase your chance of getting dementia, based on a study of women 65 years of age and older
  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older

  • Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, and dementia. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia.

    Because other products and doses have not been studied in the same way, it is not known how the use of Angeliq will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq.

What is Angeliq?

Angeliq is a prescription medicine that contains two kinds of hormones, an estrogen and a progestogen.

  • Angeliq 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) and Angeliq 0.5 mg DRSP/1 mg E2 are both used after menopause to reduce moderate to severe hot flashes.

    Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause."

    When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq.

  • Angeliq 0.5 mg drospirenone (DRSP)/1 mg estradiol (E2) is used after menopause to treat menopausal changes in or around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq to control these problems. If you use Angeliq only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

Who should not use Angeliq?

Do not start using Angeliq if you:

  • have had your uterus (womb) removed (hysterectomy). Angeliq contains a progestogen to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestogen and you should not use Angeliq.
  • have unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Have been diagnosed with a bleeding disorder.
  • currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should use Angeliq.
  • currently have or have had blood clots.
  • Had a stroke or heart attack
  • have kidney disease, liver disease, or disease of your adrenal glands. Angeliq contains drospirenone which may increase the potassium level in your blood. Liver, kidney, or adrenal gland disease may also increase the potassium level in your blood.
  • are allergic to Angeliq or any of its ingredients. See the list of ingredients in Angeliq at the end of this leaflet.

Before you use Angeliq, tell your healthcare provider if you:

  • have or have had problems with your adrenal glands
  • have high levels of fat in your blood (triglycerides)

  • have any other medical conditions that may become worse while you are using Angeliq

    Your healthcare provider may need to check you more carefully if you have certain conditions, such as:

    • asthma (wheezing)
    • epilepsy (seizures)
    • diabetes
    • migraine
    • endometriosis
    • lupus
    • have high potassium levels in your blood
    • hypertension (high blood pressure)
    • problems with your heart, liver, thyroid or kidneys
    • benign breast disease
    • have high calcium in your blood
    • have low sodium levels in your blood

  • are pregnant or think you may be pregnant

    Angeliq is not for pregnant women.

  • are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop using Angeliq.

  • are breastfeeding

    The hormones in Angeliq can pass into your milk.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Angeliq works. Some other medicines and food products may increase or decrease the concentrations of the hormones in Angeliq in the blood. Angeliq may also affect how your other medicines work. Angeliq may increase the potassium level in your blood and some medicines may also increase potassium level. In some situations, your healthcare provider may recommend testing your blood for potassium level.

    Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I use Angeliq?

  • Take one Angeliq tablet at the same time each day.
  • Take Angeliq tablets whole. Do not break, crush, dissolve, or chew Angeliq tablets before swallowing. If you cannot swallow Angeliq tablets whole, tell your healthcare provider. You may need a different medicine.
  • If you miss a dose of Angeliq, take it as soon as possible.
  • If more than 24 hours have passed since you missed a dose of Angeliq, you should not take the missed dose.
  • Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with Angeliq.

What are the possible side effects of Angeliq?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious but less common side effects include:

  • Heart attack
  • Stroke
  • Blood clots
  • High potassium levels in your blood (hyperkalemia)
  • Cancer of the lining of the uterus (womb)
  • Breast cancer
  • Cancer of the ovary
  • Dementia
  • Enlargement of benign tumors of the uterus ("fibroids")
  • Gallbladder disease
  • High or low blood calcium
  • High blood pressure
  • High levels of fat (triglycerides) in your blood
  • Liver problems
  • Changes in your thyroid hormone levels
  • Fluid retention
  • Worsening of swelling of face and tongue (angioedema) in women with a history of angioedema

Call your healthcare provider right away if you have any of the following warning signs or any other unusual symptoms that concern you:

  • New breast lumps
  • Changes in vision or speech
  • Unusual vaginal bleeding
  • Sudden new severe headaches
  • Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Common side effects of Angeliq include:

  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach or abdominal pain
  • Nausea
  • Diarrhea
  • Vaginal yeast infection
  • Fluid Retention
  • Moodiness

These are not all the possible side effects of Angeliq. For more information, ask your healthcare provider or pharmacist about side effects.

You may report side effects to Bayer HealthCare Pharmaceuticals at 1-888-842-2937 or to FDA at 1-800-FDA-1088.

How should I store Angeliq?

Store Angeliq at room temperature between 68˚F to 77˚F (20˚C to 25˚C).

Keep Angeliq and all medicines out of the reach of children.

What can I do to lower my chances of a serious side effect with Angeliq?

  • Talk with your healthcare provider regularly about whether you should continue using Angeliq.
  • If you have a uterus, talk with your healthcare provider about whether Angeliq is right for you.
  • In general, the addition of a progestogen is recommended for a women with a uterus to reduce the chances of getting cancer of the uterus (womb).
  • See your healthcare provider right away if you get vaginal bleeding while using Angeliq.
  • Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Angeliq.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Angeliq for conditions for which it was not prescribed. Do not give Angeliq to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Angeliq that is written for health professionals.

For more information, go to www.angeliq-us.com by or calling our toll free number (1-888-842-2937).

What are the ingredients in Angeliq?

Active ingredients: drospirenone (a progestin) and estradiol.

Inactive ingredients 0.5 mg DRSP/1 mg E2 tablets: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and ferric oxide pigment NF.

Inactive ingredients in 0.25 mg DRSP/0.5 mg E2 tablets: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and yellow ferric oxide pigment NF.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.

Whippany, NJ 07981

©2015 Bayer HealthCare Pharmaceuticals Inc

All rights reserved.

October 2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021355 · View the label on DailyMed

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Drug information for Angeliq

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Estrogen, Progestin
Active ingredients Estradiol, Drospirenone
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) BAYER HLTHCARE
FDA approval NDA 021355New Drug Application (NDA) Approved September 28, 2005
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1 mg, 0.5 mg – 28 in 1 blister pack / 3 in 1 carton NDC 50419-483-01
1 mg, 0.5 mg – 14 in 1 blister pack / 1 in 1 carton NDC 50419-483-71
0.5 mg, 0.25 mg – 28 in 1 blister pack / 3 in 1 carton NDC 50419-482-01
0.5 mg, 0.25 mg – 14 in 1 blister pack / 1 in 1 carton NDC 50419-482-71

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.