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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Premarin:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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; light-headedness; mild fluid retention; 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.

Seek medical attention right away if any of these SEVERE side effects occur when using Premarin Cream:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf pain or tenderness; 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; 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; 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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; hair loss; headache; leg cramps; mild fluid retention; mild nausea or vomiting; nervousness; spotting or breakthrough bleeding; stomach cramps or bloating; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Premarin Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal vaginal bleeding; breast lumps or pain; calf pain, swelling, or tenderness; chest pain; confusion; coughing up blood; fainting; mental or mood changes (eg, depression); migraine headache; new or worsening memory problems; one-sided weakness; severe or persistent dizziness or headache; severe or persistent stomach pain or tenderness; shortness of breath; slurred speech; sudden, severe, or persistent vomiting; swelling of the hands or feet; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); unusual vaginal discharge/itching/odor; vision loss or other vision changes; vomiting; weakness or numbness of an arm or leg.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Premarin Side Effects - for the Professional

Premarin

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials 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.

During the first year of a 2-year clinical trial with 2,333 postmenopausal women between 40 and 65 years of age (88 percent Caucasian), 1,012 women were treated with conjugated estrogens and 332 were treated with placebo. Table 6 summarizes adverse events that occurred at a rate of ≥ 5 percent.

TABLE 6. NUMBER (%) OF PATIENTS REPORTING ≥ 5 PERCENT TREATMENT EMERGENT ADVERSE EVENTS

	--Conjugated Estrogens Treatment Group--
Body System	0.625 mg	0.45 mg	0.3 mg	Placebo
Adverse event	(n = 348)	(n = 338)	(n = 326)	(n = 332)
Any adverse event	323 (93%)	305 (90%)	292 (90%)	281 (85%)
Body as a Whole
Abdominal pain    Accidental injury    Asthenia    Back pain    Flu syndrome    Headache    Infection    Pain	56 (16%) 21 (6%) 25 (7%) 49 (14%) 37 (11%) 90 (26%) 61 (18%) 58 (17%)	50 (15%) 41 (12%) 23 (7%) 43 (13%) 38 (11%) 109 (32%) 75 (22%) 61 (18%)	54 (17%) 20 (6%) 25 (8%) 43 (13%) 33 (10%) 96 (29%) 74 (23%) 66 (20%)	37 (11%) 29 (9%) 16 (5%) 39 (12%) 35 (11%) 93 (28%) 74 (22%) 61 (18%)
Digestive System
Diarrhea    Dyspepsia    Flatulence    Nausea	21 (6%) 33 (9%) 24 (7%) 32 (9%)	25 (7%) 32 (9%) 23 (7%) 21 (6%)	19 (6%) 36 (11%) 18 (6%) 21 (6%)	21 (6%) 46 (14%) 9 (3%) 30 (9%)
Musculoskeletal System
Arthralgia    Leg cramps    Myalgia	47 (14%) 19 (5%) 18 (5%)	42 (12%) 23 (7%) 18 (5%)	22 (7%) 11 (3%) 29 (9%)	39 (12%) 7 (2%) 25 (8%)
Nervous System
Depression    Dizziness    Insomnia    Nervousness	25 (7%) 19 (5%) 21 (6%) 12 (3%)	27 (8%) 20 (6%) 25 (7%) 17 (5%)	17 (5%) 12 (4%) 24 (7%) 6 (2%)	22 (7%) 17 (5%) 33 (10%) 7 (2%)
Respiratory System
Cough increased    Pharyngitis    Rhinitis    Sinusitis    Upper respiratory infection	13 (4%) 35 (10%) 21 (6%) 22 (6%) 42 (12%)	22 (7%) 35 (10%) 30 (9%) 36 (11%) 34 (10%)	14 (4%) 40 (12%) 31 (10%) 24 (7%) 28 (9%)	14 (4%) 38 (11%) 42 (13%) 24 (7%) 35 (11%)
Skin and Appendages
Pruritus	14 (4%)	17 (5%)	16 (5%)	7 (2%)
Urogenital System
Breast pain    Leukorrhea    Vaginal hemorrhage    Vaginal moniliasis    Vaginitis	38 (11%) 18 (5%) 47 (14%) 20 (6%) 24 (7%)	41 (12%) 22 (7%) 14 (4%) 18 (5%) 20 (6%)	24 (7%) 13 (4%) 7 (2%) 17 (5%) 16 (5%)	29 (9%) 9 (3%) 0 6 (2%) 4 (1%)

Postmarketing Experience

The following additional adverse reactions have been identified during post approval use of Premarin. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Abnormal uterine bleeding, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer, leukorrhea.

Breast

Tenderness, enlargement, pain, discharge, galactorrhea, fibrocystic breast changes, breast cancer, gynecomastia in males.

Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, enlargement of hepatic hemangiomas, ischemic colitis.

Skin

Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, loss of scalp hair, hirsutism, pruritus, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache, migraine, dizziness, mental depression, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia, possible growth potentiation of benign meningioma.

Miscellaneous

Increase or decrease in weight, glucose intolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, exacerbation of asthma, increased triglycerides, hypersensitivity.

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

Top

Side Effects by Body System - for Healthcare Professionals

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.

Top

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.