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Duavee

Last reviewed on RxList: 1/6/2020
Duavee Side Effects Center

Last reviewed on RxList 1/6/2020

What Is Duavee?

Duavee (conjugated estrogens/bazedoxifene) contains a form of the female hormone, estrogen, along with an estrogen agonist/antagonist used to treat moderate to severe vasomotor symptoms associated with menopause and to prevent postmenopausal osteoporosis in women who still have a uterus.

What Are Side Effects of Duavee?

Common side effects of Duavee include:

Dosage for Duavee

The recommended dosage is one Duavee tablet daily.

What Drugs, Substances, or Supplements Interact with Duavee?

Duavee may interact with St. John's Wort, phenobarbital, carbamazepine, rifampin, antibiotics, azole antifungals, ritonavir, grapefruit juice, and phenytoin. Tell your doctor all medications and supplements you use.

Duavee During Pregnancy and Breastfeeding

Duavee must not be used in women who are or may become pregnant. It is unknown if this drug is passes into breast milk. Estrogens can decrease the quantity and quality of the milk. Duavee is not recommended for use while breastfeeding.

Additional Information

Our Duavee (conjugated estrogens/bazedoxifene) 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.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Duavee Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Cardiovascular Disorders [see WARNINGS AND PRECAUTIONS]
  • Malignant Neoplasms [see WARNINGS AND PRECAUTIONS]
  • Gallbladder Disease [see WARNINGS AND PRECAUTIONS]
  • Hypertriglyceridemia [see 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 clinical practice.

The safety of conjugated estrogens/bazedoxifene was evaluated in four Phase 3 clinical trials ranging from 12 weeks to 24 months in duration and enrolling 6,210 postmenopausal women age 40 to 75 years (mean age 55 years). A total of 1,224 patients were treated with DUAVEE and 1,069 patients received placebo. Women enrolled in Studies 1 and 2 received calcium (600- 1200 mg) and vitamin D (200-400 IU) daily, while women in Studies 3 and 4 received no calcium and vitamin D supplementation as part of the protocol.

The incidence of all-cause mortality was 0.0% in the DUAVEE group and 0.2% in the placebo group. The incidence of serious adverse reactions was 3.5% in the DUAVEE group and 4.8% in the placebo group. The percentage of patients who withdrew from treatment due to adverse reactions was 7.5% in the DUAVEE group and 10.0% in the placebo group. The most common adverse reactions leading to discontinuation were hot flush, abdominal pain upper, and nausea.

The most commonly observed adverse reactions (incidence ≥ 5%) more frequently reported in women treated with DUAVEE than placebo are presented in Table 1.

Table 1: Adverse Reactions (Incidence ≥ 5%) More Common in the DUAVEE Treatment Group in Placebo-controlled Trials

DUAVEE
(N=1224)
n (%)
Placebo
(N=1069)
n (%)
Gastrointestinal disorders
Nausea100 (8)58 (5)
Diarrhea96 (8)57 (5)
Dyspepsia84 (7)59 (6)
Abdominal pain upper81 (7)58 (5)
Musculoskeletal and connective tissue disorders
Muscle spasms110 (9)63 (6)
Neck pain62 (5)46 (4)
Nervous system disorders
Dizziness65 (5)37 (3)
Respiratory, thoracic, and mediastinal disorders
Oropharyngeal pain80 (7)61 (6)

Venous Thromboembolism

In the clinical studies with DUAVEE, the reporting rates for venous thromboembolism (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis) were low in all treatment groups. Adverse reactions of venous thromboembolism were reported in 0.0% of patients treated with DUAVEE and 0.1% of patients treated with placebo. Due to the low rate of events in both groups, it is not possible to conclude that the risk of venous thromboembolism with DUAVEE is different from that seen with other estrogen therapies [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Duavee (Conjugated Estrogens and Bazedoxifene Tablets)

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Related Resources for Duavee

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

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