Premarin

• Overview
• Consumer Information
• Professional Information

 

Premarin Side Effects Center

What Is Premarin?

Premarin (conjugated estrogens) is a female hormone used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Premarin is also used to prevent osteoporosis in postmenopausal women, and replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Conjugated estrogens such as Premarin are sometimes used as part of cancer treatment in women and men.

What Are Side Effects of Premarin?

Common side effects of Premarin include:

• stomach upset or cramps,
• nausea,
• vomiting,
• bloating,
• breast tenderness or swelling,
• headache,
• weight or appetite changes,
• freckles or darkening of facial skin,
• increased hair growth,
• loss of scalp hair,
• problems with contact lenses,
• vaginal itching or discharge,
• changes in your menstrual periods,
• decreased sex drive,
• nervousness,
• dizziness, or
• tired feeling.

Tell your doctor if you have serious side effects of Premarin including:

• mental/mood changes (such as depression, memory loss),
• breast lumps,
• unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged or recurrent bleeding),
• increased or new vaginal irritation/itching/odor/discharge,
• severe stomach or abdominal pain,
• persistent nausea or vomiting,
• yellowing eyes or skin,
• dark urine,
• swelling hands/ankles/feet, or
• increased thirst or
• urination.

Dosage for Premarin

Women should be started at 0.3 mg Premarin daily. Dosage adjustment may be made based on patient response. Dose may vary depending on the condition being treated.

What Drugs, Substances, or Supplements Interact with Premarin?

Premarin may interact with blood thinners, thyroid medications, insulin or oral diabetes medicine, rifampin, ketoconazole or itraconazole, seizure medicines, barbiturates, or antidepressants. Tell your doctor all medications you use.

Premarin During Pregnancy and Breastfeeding

Premarin must not be used during pregnancy. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Additional Information

Our Premarin (conjugated estrogens) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Premarin Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, sweating;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, coughing up blood, pain or warmth in one or both legs;
• swelling, rapid weight gain;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood--vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• swelling;
• hair loss;
• numbness, tingling, burning pain;
• back pain, leg cramps, pain;
• bloating, gas, indigestion, nausea, vomiting, stomach pain;
• dizziness, headache;
• breast pain; or
• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Premarin (Conjugated Estrogens)

 

Premarin Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in labeling:

• Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
• Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS]

Clinical Study Experience

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 clinical practice.

During the first year of a 2-year clinical trial with 2,333 postmenopausal women with a uterus 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 1 summarizes treatment-related adverse reactions that occurred at a rate of ≥ 1 percent in any treatment group.

Table 1: TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY ≥ 1 PERCENT

	PREMARIN0.625 mg (n=348)	PREMARIN0.45 mg (n=338)	PREMARIN0.3 mg (n=326)	Placebo (n=332)
Body as a whole
Abdominal pain	38 (11)	28 (8)	30 (9)	21 (6)
Asthenia	16 (5)	8 (2)	14 (4)	3 (1)
Back pain	18 (5)	11 (3)	13 (4)	4 (1)
Chest pain	2 (1)	3 (1)	4 (1)	2 (1)
Generalized edema	7 (2)	6 (2)	4 (1)	8 (2)
Headache	45 (13)	47 (14)	44 (13)	46 (14)
Moniliasis	5 (1)	4 (1)	4 (1)	1 (0)
Pain	17 (5)	10 (3)	12 (4)	14 (4)
Pelvic pain	10 (3)	9 (3)	8 (2)	4 (1)
Cardiovascular system
Hypertension	4 (1)	4 (1)	7 (2)	5 (2)
Migraine	7 (2)	1 (0)	0	3 (1)
Palpitation	3 (1)	3 (1)	3 (1)	4 (1)
Vasodilatation	2 (1)	2 (1)	3 (1)	5 (2)
Digestive system
Constipation	7 (2)	6 (2)	4 (1)	3 (1)
Diarrhea	4 (1)	5 (1)	5 (2)	8 (2)
Dyspepsia	7 (2)	5 (1)	6 (2)	14 (4)
Eructation	1 (0)	1 (0)	4 (1)	1 (0)
Flatulence	22 (6)	18 (5)	13 (4)	8 (2)
Increased appetite	4 (1)	1 (0)	1 (0)	2 (1)
Nausea	16 (5)	10 (3)	15 (5)	16 (5)
Metabolic and nutritional
Hyperlipidemia	2 (1)	4 (1)	3 (1)	2 (1)
Peripheral edema	5 (1)	2 (1)	4 (1)	3 (1)
Weight gain	11 (3)	10 (3)	8 (2)	14 (4)
Musculoskeletal system
Arthralgia	6 (2)	3 (1)	2 (1)	5 (2)
Leg cramps	10 (3)	5 (1)	9 (3)	4 (1)
Myalgia	2 (1)	1 (0)	4 (1)	1 (0)
Nervous system
Anxiety	6 (2)	4 (1)	2 (1)	4 (1)
Depression	17 (5)	15 (4)	10 (3)	17 (5)
Dizziness	9 (3)	7 (2)	4 (1)	5 (2)
Emotional lability	3 (1)	4 (1)	5 (2)	8 (2)
Hypertonia	1 (0)	1 (0)	5 (2)	3 (1)
Insomnia	16 (5)	10 (3)	13 (4)	14 (4)
Nervousness	9 (3)	12 (4)	2 (1)	6 (2)
Skin and appendages
Acne	3 (1)	1 (0)	8 (2)	3 (1)
Alopecia	6 (2)	6 (2)	5 (2)	2 (1)
Hirsutism	4 (1)	2 (1)	1 (0)	0
Pruritus	11 (3)	11 (3)	10 (3)	3 (1)
Rash	6 (2)	3 (1)	1 (0)	2 (1)
Skin discoloration	4 (1)	2 (1)	0	1 (0)
Sweating	4 (1)	1 (0)	3 (1)	4 (1)
Urogenital system
Breast disorder	6 (2)	3 (1)	3 (1)	6 (2)
Breast enlargement	3 (1)	4 (1)	7 (2)	3 (1)
Breast neoplasm	4 (1)	4 (1)	7 (2)	7 (2)
Breast pain	37 (11)	39 (12)	24 (7)	26 (8)
Cervix disorder	8 (2)	4 (1)	5 (2)	0
Dysmenorrhea	12 (3)	10 (3)	4 (1)	2 (1)
Endometrial disorder	4 (1)	2 (1)	2 (1)	0
Endometrial hyperplasia	16 (5)	8 (2)	1 (0)	0
Leukorrhea	17 (5)	17 (5)	12 (4)	6 (2)
Metrorrhagia	11 (3)	4 (1)	3 (1)	1 (0)
Urinary tract infection	1 (0)	2 (1)	1 (0)	4 (1)
Uterine fibroids enlarged	6 (2)	1 (0)	2 (1)	2 (1)
Uterine spasm	11 (3)	5 (1)	3 (1)	2 (1)
Vaginal dryness	1 (0)	2 (1)	1 (0)	6 (2)
Vaginal hemorrhage	46 (13)	13 (4)	6 (2)	0
Vaginal moniliasis	14 (4)	10 (3)	12 (4)	5 (2)
Vaginitis	18 (5)	7 (2)	9 (3)	1 (0)

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 always to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary system

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

Breasts

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.

Read the entire FDA prescribing information for Premarin (Conjugated Estrogens)

&Copy; Premarin Patient Information is supplied by Cerner Multum, Inc. and Premarin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.