Premarin Vaginal Cream Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Premarin Vaginal Cream?

Premarin Vaginal Cream (conjugated estrogens) is a mixture of estrogen hormones, a female sex hormone produced by the ovaries, used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse.

What Are Side Effects of Premarin Vaginal Cream?

Common side effects of Premarin Vaginal Cream include:

nausea,
vomiting,
bloating,
stomach cramps,
breast pain/tenderness/swelling,
headache,
weight changes,
changes in appetite,
freckles or darkening of facial skin,
increased hair growth,
loss of scalp hair,
problems with contact lenses,
vaginal itching or discharge,
changes in your menstrual periods,
decreased sex drive,
nervousness,
dizziness, or
tired feeling.

Dosage for Premarin Vaginal Cream

Premarin Vaginal Cream is administered intravaginally in a cyclic regimen (daily for 21 days and then off for 7 days). The usual starting dosage strength is 0.5 g. Adjustments may be made based on individual response.

What Drugs, Substances, or Supplements Interact with Premarin Vaginal Cream?

Premarin Vaginal Cream may interact with blood thinners, thyroid medications, insulin or diabetes medicine taken by mouth, rifampin, ketoconazole or itraconazole, seizure medicines, barbiturates, or antidepressants. Tell your doctor all medications you are taking.

Premarin Vaginal Cream During Pregnancy and Breastfeeding

Premarin Vaginal Cream must not be used during pregnancy. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Additional Information

Our Premarin Vaginal Cream (conjugated estrogens) 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

Premarin Vaginal Cream Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
swelling or tenderness in your stomach;
jaundice (yellowing of the skin or eyes);
memory problems, confusion, unusual behavior;
unusual vaginal bleeding, pelvic pain;
a lump in your breast; or
high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

headache;
pelvic pain;
flushing (warmth, redness, or tingly feeling);
breast pain; or
vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

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.

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Premarin Vaginal Cream Professional Information

SIDE EFFECTS

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

Cardiovascular Disorders [see BOX WARNING, WARNINGS AND PRECAUTIONS]
Malignant Neoplasms [see BOX WARNING, WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial 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.

In a 12-week, randomized, double-blind, placebo-controlled trial of PREMARIN Vaginal Cream (PVC), a total of 423 postmenopausal women received at least 1 dose of study medication and were included in all safety analyses: 143 women in the PVC-21/7 treatment group (0.5 g PVC daily for 21 days, then 7 days off), 72 women in the matching placebo treatment group; 140 women in the PVC-2×/wk treatment group (0.5 g PVC twice weekly), 68 women in the matching placebo treatment group. A 40-week, openlabel extension followed, in which a total of 394 women received treatment with PVC, including those subjects randomized at baseline to placebo. In this study, the most common adverse reactions ≥ 1 percent in the double blind phase are shown below (Table 1) [see Clinical Studies].

Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Reactions ≥ 1 Percent

Body System* /Adverse Reaction	Treatment
	PVC 21/7 N=143	Placebo 21/7 N=72	PVC 2×/week N=140	Placebo 2×/week N=68
	Number (%) of Patients with Adverse Reaction
Body As A Whole
Abdominal Pain	1 (0.7)	1 (1.4)	0	1 (1.5)
Headache	5 (3.5)	1 (1.4)	3 (2.1)	1 (1.5)
Moniliasis	2 (1.4)	1 (1.4)	1 (0.7)	0
Pain	2 (1.4)	0	1 (0.7)	0
Pelvic Pain	4 (2.8)	2 (2.8)	4 (2.9)	0
Cardiovascular System
Migraine	0	0	0	1 (1.5)
Vasodilation	3 (2.1)	2 (2.8)	2 (1.4)	0
Musculoskeletal System
Muscle Cramp	2 (1.4)	0	0	0
Nervous Sys tem
Dizziness	1 (0.7)	0	0	1 (1.5)
Skin and Appendages
Acne	0	0	2 (1.4)	0
Erythema	0	1 (1.4)	0	0
Pruritus	2 (1.4)	1 (1.4)	1 (0.7)	0
Urogenital System
Breast Enlargement	1 (0.7)	1 (1.4)	0	0
Breast Pain	7 (4.9)	0	3 (2.1)	0
Dysuria	2 (1.4)	0	0	0
Leukorrhea	3 (2.1)	1 (1.4)	4 (2.9)	5 (7.4)
Metrorrhagia	0	0	0	2 (2.9)
Urinary Frequency	0	1 (1.4)	0	0
Urinary Tract Infection	0	1 (1.4)	0	0
Urinary Urgency	1 (0.7)	1 (1.4)	0	0
Vaginal Hemorrhage	2 (1.4)	0	1 (0.7)	1 (1.5)
Vaginal Moniliasis	2 (1.4)	0	0	0
Vaginitis	2 (1.4)	1 (1.4)	3 (2.1)	3 (4.4)
Vulvovaginal Disorder	4 (2.8)	0	3 (2.1)	2 (2.9)
*Body system totals are not necessarily the sum of individual adverse events, since a patient may report two or more different adverse reactions in the same body system.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PREMARIN Vaginal Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Abnormal uterine bleeding or spotting, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis (including vaginal candidiasis), change in cervical secretion, cystitis-like syndrome, application site reactions of vulvovaginal discomfort, (including burning, irritation, and genital pruritus), endometrial hyperplasia, endometrial cancer, precocious puberty, leukorrhea.

Breasts

Tenderness, enlargement, pain, discharge, fibrocystic breast changes, breast cancer, gynecomastia in males.

Cardiovascular

Body system totals are not necessarily the sum of individual adverse events, since a patient may report two or more different adverse reactions in the same body system.

Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal cramps, bloating, increased incidence of gallbladder disease.

Skin

Chloasma that may persist when drug is discontinued, loss of scalp hair, hirsutism, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache, migraine, dizziness, mental depression, nervousness, mood disturbances, irritability, dementia.

Miscellaneous

Increase or decrease in weight, glucose intolerance, edema, arthralgias, leg cramps, changes in libido, urticaria, exacerbation of asthma, increased triglycerides, hypersensitivity.

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

Read the entire FDA prescribing information for Premarin Vaginal Cream (Conjugated Estrogens Vaginal Cream)