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Angeliq

Last reviewed on RxList: 7/13/2015
Angeliq Side Effects Center

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.

Angeliq Consumer Information

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)

Angeliq Professional Information

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)

Related Resources for Angeliq

Read the Angeliq User Reviews »

© Angeliq Patient Information is supplied by Cerner Multum, Inc. and Angeliq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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