Premarin Side Effects

Please note - some side effects for Premarin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Premarin - for the Consumer

Premarin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Premarin:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

Premarin Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Premarin Cream:

Back pain; bloating; breast pain or tenderness; diarrhea; dizziness; headache; increased cough; increased or decreased interest in sex; irregular vaginal bleeding or spotting; lightheadedness; mild hair loss; mild vaginal burning, itching, or irritation; muscle aches or cramps; nausea; sore throat; stomach pain or cramping; trouble sleeping; vomiting; weakness; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; changes in vision or speech; chest pain; confusion; dark urine; depression; fainting; fever, chills or persistent sore throat; mental or mood changes; one-sided weakness; pain or tenderness in the calves; persistent pain or tenderness in the upper abdomen; severe or persistent dizziness or headache; severe or persistent stomach or back pain with nausea or vomiting; sudden shortness of breath; swelling of the hands or feet; unusual vaginal bleeding or discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

Premarin Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Premarin Tablets:

Breast pain or tenderness; gas; headache; hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps or pain; calf pain, swelling, or tenderness; changes in vision or speech; chest pain; dizziness; fainting; mental or mood changes; pain in the calves; pain or tenderness in the upper abdomen; severe headache; severe stomach pain; slurred speech; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

Side Effects by Body System

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 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 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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