Premarin Vaginal Side Effects

Generic Name: conjugated estrogens topical

Note: This document contains side effect information about conjugated estrogens topical. Some of the dosage forms listed on this page may not apply to the brand name Premarin Vaginal.

Some side effects of Premarin Vaginal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to conjugated estrogens topical: vaginal cream

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

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

Oncologic

Oncologic side effects have included an increased risks of endometrial carcinoma, ovarian cancer, and breast cancer.

Cardiovascular

Cardiovascular side effects have included deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, increase in blood pressure, and myocardial infarction.

The manufacturer recommends close observation if conjugated estrogens must be used in patients who may be particularly sensitive to fluid retention because of underlying asthma, epilepsy, migraine, heart disease, and renal dysfunction.

Genitourinary

Genitourinary side effects have included breakthrough bleeding, spotting, changes in vaginal bleeding pattern, abnormal withdrawal bleeding or flow, dysmenorrhea, increase the size of preexisting uterine leiomyomata, vaginitis, including vaginal candidiasis, change in cervical erosion and in degree of cervical secretion, cystitis like syndrome, application site reactions of vulvovaginal discomfort including burning and irritation, genital pruritus, ovarian cancer, endometrial hyperplasia, and precocious puberty. Additional side effects have included breast enlargement, breast pain, dysuria, leukorrhea, metrorrhagia, urinary frequency, urinary tract infection, urinary urgency, vaginal hemorrhage, vaginal moniliasis, vaginitis, and vulvovaginal disorder.

Metabolic

Metabolic side effects have included increased serum triglyceride levels and reduced carbohydrate tolerance. Aggravation of porphyria has been reported.

General

General side effects have included reports of fluid retention, and increase or decrease in weight.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, pancreatitis, and increased incidence of gallbladder disease. Ischemic colitis has also been reported.

Hematologic

Hematologic side effects have included hypercoagulability. Several cases of the hemolytic uremic syndrome have also been associated with conjugated estrogen therapy.

Hepatic

Hepatic side effects have included enlargement of hepatic hemangiomas and rare cases of focal nodular hyperplasia, liver cell adenomas, hepatic hemangiomas and well differentiated hepatocellular carcinomas.

Many of the reports of hepatic tumors have occurred in women taking long-term oral contraceptives. However, some tumors have been reported in women taking isolated estrogen therapy.

Nervous system

Nervous system side effects have included migraine, dizziness, nervousness, mood disturbances, irritability, chorea, exacerbation of epilepsy, dementia, and mental depression. Possible growth potentiation of benign meningioma has also been reported.

Other

Other side effects have included breast tenderness, pain, enlargement, secretion, and fibrocystic breast changes. Postmarketing experience has included reports of gynecomastia in males.

Psychiatric

Psychiatric side effects have included reports of rapid mood cycling in patients with severe depression.

Hypersensitivity

Hypersensitivity side effects have been reported in postmarketing experience.

Respiratory

Respiratory side effects have included pulmonary embolism, exacerbation of asthma, and rare cases of exacerbations of pulmonary lymphangioleiomyomatosis. In addition, combinations of high-dose conjugated estrogens and progestin have been reported to increase ventilation and increase the hypoxic ventilatory response.

Dermatologic

Dermatologic side effects have included chloasma or melasma, which did not always resolve following discontinuation of estrogen therapy, scalp hair loss, hirsutism, erythema multiforme, erythema nodosum, rash, pruritus, and hemorrhagic eruptions. Acne and erythema have also been reported.

Endocrine

Endocrine side effects have included increased levels of thyroxin-binding globulin, leading to an increase in total thyroid serum levels and a decrease in resin uptake of T3. Free thyroid hormone levels remain unchanged. Other endocrine effects include decreased fasting plasma glucose.

Ocular

Ocular side effects have included retinal vascular thrombosis and intolerance to contact lenses.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Learn about treatments for OA knee pain to help you stay active. Watch Video

Close
Hide
(web1)