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Premarin Vaginal Cream

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Premarin Vaginal Cream

Premarin Vaginal Cream Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Premarin Vaginal Cream (conjugated estrogens) is a mixture of estrogen hormones used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse. Estrogen is a female sex hormone produced by the ovaries. Common side effects include nausea/vomiting, bloating, breast tenderness, headache, or weight changes.

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. 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 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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Premarin Vaginal Cream in Detail - Patient Information: Side Effects

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 vaginal conjugated estrogens 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, confusion, problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • abnormal vaginal bleeding;
  • migraine headache;
  • pain, swelling, or tenderness in your stomach;
  • confusion, problems with memory or concentration;
  • jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet; or
  • a breast lump.

Less serious side effects may include:

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

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 Premarin Vaginal Cream (Conjugated Estrogens Vaginal Cream) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Premarin Vaginal Cream Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Premarin Vaginal Cream (Conjugated Estrogens Vaginal Cream)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Premarin Vaginal Cream FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Clinical Study 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-2x/wk treatment group (0.5 g PVC twice weekly), 68 women in the matching placebo treatment group. A 40-week, open-label 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 ≥ 5 percent are shown below (Table 1) [see Clinical Studies].

Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Events ≥ 5 Percent Only

Body Systema
Adverse Event
Treatment
PVC 21/7 21/7 (n=143) Placebo (n=72) PVC 2x/wk
(n=140)
Placebo 2x/wk
(n=68)
Number (%) of Patients with Adverse Event
Any Adverse Event 95 (66.4) 45 (62.5) 97 (69.3) 46 (67.6)
Body As A Whole
Abdominal Pain 11 (7.7) 2 (2.8) 9 (6.4) 6 (8.8)
Accidental Injury 4 (2.8) 5 (6.9) 9 (6.4) 3 (4.4)
Asthenia 8 (5.6) 0 2 (1.4) 1 (1.5)
Back Pain 7 (4.9) 3 (4.2) 13 (9.3) 5 (7.4)
Headache 16 (11.2) 9 (12.5) 25 (17.9) 12 (17.6)
Infection 7 (4.9) 5 (6.9) 16 (11.4) 5 (7.4)
Pain 10 (7.0) 3 (4.2) 4 (2.9) 4 (5.9)
Cardiovascular System
Vasodilatation 5 (3.5) 4 (5.6) 7 (5.0) 1 (1.5)
Digestive System
Diarrhea 4 (2.8) 2 (2.8) 10 (7.1) 1 (1.5)
Nausea 5 (3.5) 4 (5.6) 3 (2.1) 3 (4.4)
Musculoskeletal System
Arthralgia 5 (3.5) 5 (6.9) 6 (4.3) 4 (5.9)
Nervous System
Insomnia 6 (4.2) 3 (4.2) 4 (2.9) 4 (5.9)
Respiratory System
Cough Increased 0 1 (1.4) 7 (5.0) 3 (4.4)
Pharyngitis 3 (2.1) 2 (2.8) 7 (5.0) 3 (4.4)
Sinusitis 1 (0.7) 3 (4.2) 2 (1.4) 4 (5.9)
Skin And Appendages 12 (8.4) 7 (9.7) 16 (11.4) 3 (4.4)
Urogenital System
Breast Pain 8 (5.6) 1 (1.4) 4 (2.9) 0
Leukorrhea 3 (2.1) 2 (2.8) 4 (2.9) 6 (8.8)
Vaginitis 8 (5.6) 3 (4.2) 7 (5.0) 3 (4.4)
a Body system totals are not necessarily the sum of the individual adverse events, since a patient may report two or more different adverse events in the same body system.

Postmarketing Experience

The following adverse reactions have been reported with 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/spotting, dysmenorrhea/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

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, anaphylactic reactions, 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) »

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Premarin Vaginal Cream - User Reviews

Premarin Vaginal Cream User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Premarin Vaginal Cream sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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