Note: This document contains side effect information about conjugated estrogens topical. Some dosage forms listed on this page may not apply to the brand name Premarin Vaginal.
Applies to conjugated estrogens topical: vaginal cream.
Warning
Vaginal route (Cream)
Endometrial Cancer, Cardiovascular Disorders, Breast Cancer and Probable DementiaEstrogen-Alone TherapyThere is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.Women's Health Initiative estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis.The Women’s Health Initiative Memory Study estrogen-alone ancillary study of Women’s Health Initiative reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.Estrogen Plus Progestin TherapyEstrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.The Women’s Health Initiative estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism, and myocardial infarction.The Women’s Health Initiative estrogen plus progestin substudy reported increased risks of invasive breast cancer.The Women’s Health Initiative Memory Study estrogen plus progestin ancillary study of Women’s Health Initiative reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.
Serious side effects of Premarin Vaginal
Along with its needed effects, conjugated estrogens topical (the active ingredient contained in Premarin Vaginal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking conjugated estrogens topical:
More common
- Breast pain
- change in vaginal discharge
- cough or hoarseness
- fever or chills
- increased clear or white vaginal discharge
- itching of the vagina or genital area
- lower back or side pain
- pain during sexual intercourse
- pain or feeling of pressure in the pelvis
- painful or difficult urination
- thick, white vaginal discharge with no odor or with a mild odor
- vaginal bleeding
Less common
- Feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- headache
- sweating
Incidence not known
- Abdominal or stomach bloating
- abnormal uterine bleeding or spotting
- acne
- anxiety
- bloody or cloudy urine
- breast tenderness, enlargement, pain, or discharge
- chest pain or discomfort
- decreased vision or other changes in vision
- difficulty with swallowing
- enlargement of the penis or testes
- fast heartbeat
- frequent urge to urinate
- growth of pubic hair
- hives
- itching
- itching of the vagina or outside genitals
- nausea
- pain during sexual intercourse
- pain or discomfort in the arms, jaw, back, or neck
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid increase in height
- shortness of breath
- stomach pain
- sudden shortness of breath or troubled breathing
- sweating
- tightness in the chest
- unusual tiredness or weakness
- vomiting
- wheezing
Other side effects of Premarin Vaginal
Some side effects of conjugated estrogens topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abdominal or stomach pain
- back pain
- diarrhea
- headache
- lack or loss of strength
Less common
- Body aches or pain
- congestion
- increased dryness or soreness of the throat
- runny nose
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
Incidence not known
- Abdominal or stomach cramps
- changes in weight
- decreased or increased interest in sexual intercourse
- depression
- difficulty with moving
- headache, severe and throbbing
- heavy bleeding
- inability to have or keep an erection
- increased hair growth, especially on the face
- irritability
- itching of the vagina or genitals
- leg cramps
- loss of scalp hair
- loss or increase in sexual ability, desire, drive, or performance
- mood changes
- muscle pain or stiffness
- nervousness
- pain
- pain in the joints
- patchy brown or dark brown discoloration of the skin
- poor insight and judgment
- problems with memory or speech
- swelling of the breasts or breast soreness in both females and males
- trouble recognizing objects
- trouble thinking and planning
- weakness
For Healthcare Professionals
Applies to conjugated estrogens topical: vaginal cream with applicator.
Genitourinary
Common (1% to 10%): Breast pain, leukorrhea, dysuria, vaginal hemorrhage, vaginal moniliasis, vaginitis, vulvovaginal disorder
Uncommon (0.1% to 1%): Breast enlargement, urinary urgency
Postmarketing reports: Abnormal uterine bleeding or spotting, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, 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, breast tenderness, breast discharge, fibrocystic breast changes, breast cancer, gynecomastia in males[Ref]
Cardiovascular
Common (1% to 10%): Vasodilation
Postmarketing reports: Deep vein thrombosis, myocardial infarction, increase in blood pressure[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Postmarketing reports: Stroke, migraine, dementia[Ref]
Gastrointestinal
Postmarketing reports: Nausea, vomiting, abdominal cramps, bloating[Ref]
Dermatologic
Common (1% to 10%): Acne, pruritus
Postmarketing reports: Chloasma that may persist when drug is discontinued, loss of scalp hair, hirsutism, rash[Ref]
Other
Common (1% to 10%): Moniliasis, pain
Postmarketing reports: Increase or decrease in weight, edema[Ref]
Psychiatric
Postmarketing reports: Mental depression, mood disturbances, nervousness, irritability, changes in libido[Ref]
Respiratory
Postmarketing reports: Pulmonary embolism, exacerbation of asthma[Ref]
Musculoskeletal
Common (1% to 10%): Muscle cramp
Postmarketing reports: Arthralgias, leg cramps[Ref]
Hypersensitivity
Postmarketing reports: Hypersensitivity[Ref]
Hepatic
Postmarketing reports: Increased incidence of gallbladder disease[Ref]
Metabolic
Postmarketing reports: Glucose intolerance, increased triglycerides[Ref]
Ocular
Postmarketing reports: Retinal vascular thrombosis, intolerance to contact lenses[Ref]
