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Angeliq

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Angeliq

Angeliq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Angeliq (drospirenone and estradiol) is used to treat the symptoms of menopause such as hot flashes or vaginal changes (itching, burning, dryness, urination problems). It is also used to prevent thinning of the bones (osteoporosis), and also treats the symptoms of premenstrual dysphoric disorder (PMDD). This medication is a combination of female hormones. Common side effects include dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, nausea, weight changes, increased/decreased interest in sex, change in vaginal discharge, or breast tenderness.

The dosage of Angeliq is one tablet daily. Angeliq may interact with insulin or oral diabetes medicines, or blood thinners. Tell your doctor all medications and supplements you use. Angeliq must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. Small amounts of this medication pass into breast milk, and may reduce the quality and amount of breast milk. Consult your doctor before breastfeeding.

Our Angeliq (drospirenone and estradiol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Angeliq in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • shortness of breath;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • unusual vaginal bleeding;
  • stomach pain, swelling, or tenderness;
  • jaundice (yellowing of the skin or eyes); or
  • breast lump.

Continue using drospirenone and estradiol and talk with your doctor if you have any of these less serious side effects:

  • nausea and vomiting;
  • breast tenderness or enlargement;
  • swelling of your hands or feet;
  • darkened skin, especially on your face;
  • changes in your menstrual periods;
  • headache, migraine, dizziness, or fainting;
  • problems with contact lenses;
  • depression;
  • vaginal yeast infections; or
  • enlargement of uterine fibroids.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Angeliq (Drospirenone and Estradiol) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Angeliq Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, nausea, weight changes, increased/decreased interest in sex, change in vaginal discharge, or breast tenderness may occur. If any of these persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, memory loss), breast lumps, nipple discharge, swelling of the hands/feet, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/returning bleeding), yellowing eyes/skin, stomach/abdominal pain, worsening of a seizure condition, muscle weakness, signs of worsening diabetes control (e.g., increased thirst and urination), symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, pulmonary embolism, stroke, heart attack). Get medical help right away if you experience: pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden shortness of breath, coughing up blood, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, confusion, slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness), unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Angeliq (Drospirenone and Estradiol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Angeliq FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS, AND PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The following are adverse events reported with ANGELIQ (drospirenone and estradiol) occurring in > 5% of subjects:

Table 4: Adverse Events Regardless of Drug Relationship Reported at a Frequency of > 5% in a 1-year Double-blind Clinical Trial

ADVERSE EVENT E2 1 MG
(N=226)
n (%)
ANGELIQ (drospirenone and estradiol)
(N=227)
n (%)
BODY AS A WHOLE
   Abdominal pain 29 (12.8) 25 (11)
   Pain in extremity 15 (6.6) 19 8 ( .4)
   Back pain 11 (4.9) 16 (7)
   Flu syndrome 15 (6.6) 16 (7)
   Accidental injury 15 (6.6) 13 (5 .7)
   Abdomen enlarged 17 (7.5) 16 (7)
   Surgery 6 (2.7) 12 (5.3)
METABOLIC & NUTRITIONAL DISORDERS
   Peripheral edema 12 (5.3) 4 (1 .8)
NERVOUS SYSTEM
   Headache 26 (11.5) 22 (9.7)
RESPIR ATORY SYSTEM
   Upper respiratory infection 40 (17.7) 43 (18.9)
   Sinusitis 8 (3.5) 12 (5.3)
SKIN AND APPENDAGES
   Breast pain 34 (15) 43 (18.9)
UROGENITAL
   Vaginal hemorrhage 43 (19) 21 (9.3 )
   Endometrial disorder 22 (9.7) 4 (1.8)
   Leukorrhea 14 (6.2) 3 (1.3)

The following additional adverse reactions have been reported with estrogen and or estrogen/progestin therapy:

Genitourinary system

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma, which may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central nervous system

Headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia.

Miscellaneous

Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, anaphylactoid/anaphylactic reactions including urticaria and angioedema, hypocalcemia, exacerbation of asthma, increased triglycerides.

Read the entire FDA prescribing information for Angeliq (Drospirenone and Estradiol) »

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Angeliq - User Reviews

Angeliq User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Angeliq sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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