What the label lists and what reports show
Bazedoxifene and estrogens conjugated side effects
Bazedoxifene and estrogens conjugated's FDA label: “The most common adverse reactions leading to discontinuation were hot flush, abdominal pain upper, and nausea.” FAERS holds 932 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hot flush (78 reports).
- No generic listed
- Boxed warning
Check it at the source: the bazedoxifene and estrogens conjugated FDA label on DailyMed (effective April 28, 2026, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What is the most important information I should know about DUAVEE?Do not take additional estrogen products while you are taking DUAVEE. • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). • Report any unusual vaginal bleeding right away while you are taking DUAVEE. 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. • Do not use estrogens 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 chances of getting dementia, based on a study of women 65 years of age or older. • The risks listed above are based on a study of an estrogen-alone oral product. Since other products and doses have not been studied in the same way, it is not known how the use of DUAVEE will affect your chances of getting these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.
Source: FDA drug label, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective April 28, 2026 (SPL set e1b75458-2e5b-46b9-92c6-fa6daba3770f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions leading to discontinuation were hot flush, abdominal pain upper, and nausea.
Table 1: Adverse Reactions (Incidence ≥ 5%) More Common in the DUAVEE Treatment Group in Placebo-controlled Trials
| Reaction | DUAVEE (N=1224) n (%) | Placebo (N=1069) n (%) |
|---|---|---|
| Nausea | 100 (8) | 58 (5) |
| Diarrhea | 96 (8) | 57 (5) |
| Dyspepsia | 84 (7) | 59 (6) |
| Abdominal pain upper | 81 (7) | 58 (5) |
| Muscle spasms | 110 (9) | 63 (6) |
| Neck pain | 62 (5) | 46 (4) |
| Dizziness | 65 (5) | 37 (3) |
| Oropharyngeal pain | 80 (7) | 61 (6) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the label: • Cardiovascular Disorders [see Warnings and Precautions (5.2) ] • Malignant Neoplasms [see Warnings and Precautions (5.3) ] • Gallbladder Disease [see Warnings and Precautions (5.5) ] • Hypertriglyceridemia [see Warnings and Precautions (5.8) ] In four prospective, randomized, placebo-controlled trials the common adverse reactions (incidence ≥ 5%) were muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. …
Source: FDA drug label, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective April 28, 2026 (SPL set e1b75458-2e5b-46b9-92c6-fa6daba3770f), via openFDA; the full label on DailyMed
What do FAERS reports show?
932 reports list bazedoxifene and estrogens conjugated among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 34 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bazedoxifene and estrogens conjugated: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions