Premarin Side Effects

Generic name: conjugated estrogens

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

Some side effects of Premarin 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: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking conjugated estrogens (the active ingredient contained in Premarin) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using 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 of conjugated estrogens 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

• mild 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.

For Healthcare Professionals

Applies to conjugated estrogens: injectable powder for injection, oral tablet, vaginal cream

Oncologic

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

Cardiovascular

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

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

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.

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

Cases of oral pigmentation and ischemic colitis have been reported rarely.

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, pancreatitis, ischemic colitis, and increased incidence of gallbladder disease.

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 also included many reports of hepatic tumors in women taking long-term oral contraceptives. However, some tumors have been reported in women taking isolated estrogen therapy.

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.

Nervous system

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

Other

Other side effects have included breast tenderness, pain, enlargement, secretion, and fibrocystic breast changes.

Psychiatric

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

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 (the active ingredient contained in Premarin) 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, rash, erythema multiforme, erythema nodosum, and hemorrhagic eruptions.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid/anaphylaxis reactions including urticaria and angioedema.

Endocrine

Endocrine side effects have included reports of 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 remained unchanged. Other endocrine effects have included decreased fasting plasma glucose.

Ocular

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

Local

Local side effects have included phlebitis at the injection site and injection site pain and edema.

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