Menopause

Overview 
Theory 
Diagnosis 
Management 
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Resources 

Evidence last reviewed: 21 Feb 2026

Topic last updated: 18 Mar 2026

18 Mar 2026

Food and Drug Administration (FDA) approves labeling changes to menopausal hormone therapies

The FDA has approved the removal of black box warnings for six hormone therapies, to clarify the risks of cardiovascular disease, breast cancer, and probable dementia, following a comprehensive review of the scientific literature.

Randomized studies show women who initiate hormone therapy within 10 years of the beginning of menopause, particularly before age 60 years have a reduction in all-cause mortality and fractures.

The FDA is recommending these labeling changes so that women and healthcare professionals have access to updated information on the benefits and risks of these therapies and can make better informed decisions about using them.

The updated labeling includes drugs in all four categories of hormone therapy:

Systemic combination therapy (estrogen and progestogen)
Systemic estrogen-only therapy
Systemic progestogen-only therapy (for women with a uterus using systemic estrogen)
Topical vaginal estrogen therapy

See Management: approach

Original source of update

The diagnosis of menopause is clinical, based on the absence of menses for 12 months, and does not require further testing for appropriately presenting patients.

Estrogen therapy is an effective treatment for the management of menopausal symptoms including hot flashes, night sweats, and urogenital symptoms.

For women with an intact uterus, a progestin must be co-administered with an estrogen to protect against endometrial hyperplasia and cancer.

Arbitrary limits should not be placed on the duration of use of hormone therapy (HT); all patients require individualized decision-making. Reassessment should occur at least annually. Transdermal administration of estradiol is associated with a lower risk of stroke and venous thromboembolism than oral administration of estradiol and is unlikely to increase the risk of stroke and venous thrombosis above that of non-users.

Nonhormonal interventions may help women who have a contraindication to, or cannot tolerate, HT. However, they are less effective than HT in controlling menopausal symptoms.

Definition

Onset of menopause is heralded by the cessation of menses for at least 12 consecutive months, without some other reason for amenorrhea (such as pregnancy, hormone therapy, or other medical condition). No further testing is indicated for amenorrhea in an appropriate clinical context or symptoms of menopause in a woman without a uterus.[1]

Permanent cessation of ovarian function may occur surgically by removal of both ovaries (surgical menopause) or medically, usually due to chemotherapy or radiation therapy (treatment-induced menopause).

The perimenopause includes the years before and after the cessation of menses in an ovulating woman and is marked by irregular menses and menopausal symptoms. Management of menopause symptoms requires individualization based on each woman’s clinical circumstance.

History and exam

Key diagnostic factors

amenorrhea
irregular menstrual cycle
hot flashes and night sweats
vaginal symptoms
mood changes

Full details

Other diagnostic factors

sleep disturbance
mild memory impairment
heavy menstrual bleeding

Full details

Risk factors

age 40 to 60 years
cancer treatment
smoking
ovarian surgery
mother's age at menopause

Full details

Diagnostic tests

1st tests to order

pregnancy test

Full details

Tests to consider

follicle-stimulating hormone (FSH)
serum estradiol

Full details

Treatment algorithm

ACUTE

initial presentation with mild vasomotor symptoms

ONGOING

women with a uterus, moderate to severe hot flashes, with/without reduced libido

women without a uterus or with levonorgestrel-releasing intrauterine device fitted in the last 5 years, moderate to severe hot flashes, with/without reduced libido

urogenital atrophy only

urinary stress incontinence only

Contributors

Authors

Heather Currie, MB BS, FRCOG, DRCOG, MRCGP

Clinical Director Women and Sexual Health

NHS Dumfries and Galloway

Dumfries and Galloway Royal Infirmary

Scotland

Disclosures

HC declares that she has no competing interests.

Haitham Hamoda, MBChB, MD, FRCO

Consultant Gynaecologist

Clinical Lead for Menopause Service

King's College Hospital NHS Trust

London

Disclosures

HH declares that he has no competing interests.

Bradford W. Fenton, MD, PhD, FACOG

Independence Park Medical Services

Anchorage

Disclosures

BWF declares that he has no competing interests.

Acknowledgements

Dr Heather Currie, Dr Haitham Hamoda, and Dr Bradford W. Fenton would like to gratefully acknowledge Dr Rebekah Wang-Cheng, a previous contributor to this topic.

Disclosures

RWC declares that she has no competing interests.

Peer reviewers

Nan Gillespie O’Connell, MD

Assistant Professor

Department of Obstetrics and Gynecology

Virginia Commonwealth University

Richmond

Disclosures

NGOC declares that she has no competing interests.

Carolyn Simpkins, MD, PhD

Internist

Daniel Island

Disclosures

CS declares that she has no competing interests.

Edward Morris, MD

Consultant

Honorary Senior Lecturer and Clinical Director

Department of Obstetrics and Gynaecology

Norfolk and Norwich University Hospital

Norwich

Disclosures

EM declares that he has no competing interests.

Michelle Warren, MD

Professor of Medicine and Obstetrics & Gynecology

Obstetrics and Gynecology

Columbia University in New York Medical Center

New York

Disclosures

MW has received research funding from Ferring and Pfizer Wyeth; has acted as an advisory board consultant for Pfizer Wyeth, QuatRx, and Yoplait; and is on the speakers' bureau of Amgen, Upsher Smith, and Warner Chilcott. MW is also an author of a reference cited in this topic.

Peer reviewer acknowledgements

BMJ Best Practice topics are updated on a rolling basis in line with developments in evidence and guidance. The peer reviewers listed here have reviewed the content at least once during the history of the topic.

Disclosures

Peer reviewer affiliations and disclosures pertain to the time of the review.

References

Our in-house evidence and editorial teams collaborate with international expert contributors and peer reviewers to ensure that we provide access to the most clinically relevant information possible.

Key articles

Barnabei VM, Cochrane BB, Aragaki AK, et al. Menopausal symptoms and treatment-related effects of estrogen and progestin in the Women's Health Initiative. Obstet Gynecol. 2005 May;105(5 Pt 1):1063-73. Abstract

Avis NE, Crawford SL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr;175(4):531-9.Full text Abstract

North American Menopause Society. Management of osteoporosis in postmenopausal women: the 2021 position statement of The North American Menopause Society. Menopause. 2021 Sep 1;28(9):973-97. Abstract

The North American Menopause Society Advisory Panel. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022 Jul 1;29(7):767-94. Abstract

Bofill Rodriguez M, Yong LN, Mirkov S, et al. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2025 Nov 27;11(11):CD004143. Abstract

Manson JE, Aragaki AK, Rossouw JE, et al. Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the women's health initiative randomized trials. JAMA. 2017 Sep 12;318(10):927-38. Abstract

Reference articles

A full list of sources referenced in this topic is available to users with access to all of BMJ Best Practice.

Differentials
- Pregnancy
- Polycystic ovary syndrome
- Hyperthyroidism
More Differentials
Guidelines
- Genitourinary syndrome of menopause
- Recommendations on hormone replacement therapy in menopausal women
More Guidelines
Patient information
Menopause: what is it?
Menopausal symptoms: what are the treatment options?
More Patient information
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Menopause

Food and Drug Administration (FDA) approves labeling changes to menopausal hormone therapies

Summary

Definition

History and exam

Key diagnostic factors

Other diagnostic factors

Risk factors

Diagnostic tests

1st tests to order

Tests to consider

Treatment algorithm

initial presentation with mild vasomotor symptoms

women with a uterus, moderate to severe hot flashes, with/without reduced libido

women without a uterus or with levonorgestrel-releasing intrauterine device fitted in the last 5 years, moderate to severe hot flashes, with/without reduced libido

urogenital atrophy only

urinary stress incontinence only

Contributors

Authors

Heather Currie, MB BS, FRCOG, DRCOG, MRCGP

Disclosures

Haitham Hamoda, MBChB, MD, FRCO

Disclosures

Bradford W. Fenton, MD, PhD, FACOG

Disclosures

Acknowledgements

Disclosures

Peer reviewers

Nan Gillespie O’Connell, MD

Disclosures

Carolyn Simpkins, MD, PhD

Disclosures

Edward Morris, MD

Disclosures

Michelle Warren, MD

Disclosures

Peer reviewer acknowledgements

Disclosures

References

Key articles

Reference articles

A full list of sources referenced in this topic is available to users with access to all of BMJ Best Practice.

Differentials

Guidelines

Patient information

Log in or subscribe to access all of BMJ Best Practice

Log in or subscribe to access all of BMJ Best Practice

Log in to access all of BMJ Best Practice