August 3, 2015
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Angeliq

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Angeliq




Angeliq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/7/2015

Angeliq (drospirenone and estradiol) is a combination of female hormones used to treat the symptoms of menopause such as hot flashes or vaginal changes (itching, burning, dryness, urination problems). Angeliq is also used to prevent thinning of the bones (osteoporosis), and also treats the symptoms of premenstrual dysphoric disorder (PMDD). Common side effects of Angeliq include dizziness, lightheadedness, headache, stomach upset or pain, diarrhea, bloating, irritability, mood changes, changes in sleep patterns, nausea, weight gain, increased/decreased interest in sex, change in vaginal discharge, vaginal itching, irregular vaginal bleeding or spotting, swelling in your hands or feet, or breast pain or 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; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using drospirenone and estradiol and call your doctor at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • confusion, unusual thoughts or behavior;
  • abnormal vaginal bleeding;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • severe pain in your upper stomach spreading to your back, vomiting;
  • itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • a breast lump.

Less serious side effects may include:

  • mild nausea or stomach pain, diarrhea;
  • mild headache;
  • irregular vaginal bleeding, spotting;
  • breast pain or tenderness;
  • weight gain, swelling in your hands or feet;
  • mood changes; or
  • vaginal itching or discharge.

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.

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

The following serious adverse reactions are discussed elsewhere in the labeling:

Cardiovascular Disorders [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]

Malignant Neoplasms [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

From clinical trials with different dose formulations of Angeliq containing E2 dose ranging from 0.5 mg to 1.0 mg combined with DRSP dose ranging from 0.25 mg to 3 mg:

  • The most common adverse reactions were gastrointestinal and abdominal pain, female genital bleeding, breast pain and headache. The frequencies of common adverse reactions, in general, were higher for the Angeliq dose formulation containing E2 1 mg compared to Angeliq containing E2 0.5 mg.
  • The most common adverse reactions leading to drug discontinuation in controlled clinical trials were abdominal pain, headache, postmenopausal bleeding, breast tenderness, and weight increased.
Placebo-Controlled Trial

In a placebo-controlled trial evaluating Angeliq 0.25 mg DRSP/0.5 mg E2, 183 postmenopausal women received at least one dose of DRSP 0.25 mg/0.5 mg E2 and 180 received placebo. Study subjects were treated for 3 cycles of 28 days each for a total of 12 weeks of treatment. The median age was 53 years (range: 40-77 years) and over 50% of subjects had a hysterectomy, 68% were Caucasian and 24% were Black. Table 1 summarizes adverse reactions reported in at least 2% of subjects receiving Angeliq 0.25 mg DRS/0.5 mg E2 and at a higher incidence than subjects receiving placebo.

Table 1: Adverse Reactions that Occurred at a Frequency of ≥ 2% with Angeliq 0.25 mg DRSP/0.5 mg E2 and at a higher incidence than placebo

Adverse Reaction Angeliq (0.25 mg DRSP/0.5 mg E2)
N=183 (100%)
n (%)
Placebo
N=180 (100%)
n (%)
Gastrointestinal and abdominal pains* 11 (6.0) 5 (2.8)
Headache 11 (6.0) 9 (5.0)
Vulvovaginal fungal infections 10 (5.5) 1 (0.6)
Breast pain** 6 (3.3) 1 (0.6)
Nausea 6 (3.3) 2 (1.1)
Diarrhea 4 (2.2) 1 (0.6)
Peripheral Edema 4 (2.2) 2 (1.1)
*Gastrointestinal and abdominal pain includes: abdominal pain (overall, lower, and upper), abdominal discomfort, abdominal tenderness
**Breast pain includes: breast pain, breast tenderness, nipple pain

Pooled Data Of Clinical Trials With Different Dose Formulations Of Angeliq

Data from 13 clinical trials in postmenopausal subjects treated with different dose formulations of Angeliq containing 1 mg E2 (1 mg E2 + 0.5 mg - 3.0 mg DRSP; N=2842) were pooled to provide an overall estimate of adverse reactions. Similarly, data from 2 clinical trials with Angeliq containing 0.5 mg E2 (0.5 mg E2 + DRSP 0.25 mg - 0.5 mg; N=853) were pooled for the same purpose. Table 2 shows adverse reactions reported in at least 1% of subjects treated with Angeliq.

Table 2: Adverse Reactions that Occurred at a Frequency of ≥ 1% in Clinical Trials

Adverse Reaction Angeliq containing 1 mg E2
N = 2842
n (%)
Angeliq containing 0.5 mg E2
N=853
n (%)
Breast pain or discomfort 508 (17.9) 53 (6.2)
Female genital tract bleeding 397 (14.0) 21 (2.5)
Gastrointestinal and abdominal pain 186 (6.5) 31 (3.6)
Cervical polyp 34 (1.2) 3 (0.4)
Emotional lability 35 (1.2) 11 (1.3)
Migraine 28 (1.0) 5 (0.6)

Adverse Reactions in clinical studies were coded using the MedDRA dictionary (version 13.0). Different MedDRA terms representing the same medical phenomenon have been grouped together as single adverse reactions to avoid diluting or obscuring the true effect.

Postmarketing Experience

The following additional adverse reactions have been reported during post approval use of Angeliq. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Immune System Disorders: Hypersensitivity reactions, including rash, pruritis, and urticaria

Reproductive system and breast disorders: Breast cancer

Vascular disorders: venous and arterial thromboembolic events (peripheral deep venous occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and stroke not specified as hemorrhagic)

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

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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