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; 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 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; 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; 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.

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

During the first year of a 2-year clinical trial with 2333 postmenopausal women between 40 and 65 years of age (88% Caucasian), 1012 women were treated with conjugated estrogens and 332 were treated with placebo. Table 6 summarizes adverse events that occurred at a rate of ≥ 5%.

The following additional adverse reactions have been reported with estrogen and/or progestin therapy:

1. Genitourinary system

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea
Increase in size of uterine leiomyomata
Vaginitis, including vaginal candidiasis
Change in amount of cervical secretion
Change in cervical ectropion
Ovarian cancer
Endometrial hyperplasia
Endometrial cancer

2. Breasts

Tenderness, enlargement, pain, discharge, galactorrhea
Fibrocystic breast changes
Breast cancer

3. Cardiovascular

Deep and superficial venous thrombosis
Pulmonary embolism
Thrombophlebitis
Myocardial infarction
Stroke
Increase in blood pressure

4. Gastrointestinal

Nausea, vomiting
Abdominal cramps, bloating
Cholestatic jaundice
Increased incidence of gallbladder disease
Pancreatitis
Enlargement of hepatic hemangiomas

5. Skin

Chloasma or melasma that may persist when drug is discontinued
Erythema multiforme
Erythema nodosum
Hemorrhagic eruption
Loss of scalp hair
Hirsutism
Pruritus, rash

6. Eyes

Retinal vascular thrombosis
Intolerance to contact lenses

7. Central Nervous System

Headache
Migraine
Dizziness
Mental depression
Chorea
Nervousness
Mood disturbances
Irritability
Exacerbation of epilepsy
Dementia

8. Miscellaneous

Increase or decrease in weight
Reduced carbohydrate tolerance
Aggravation of porphyria
Edema
Arthralgias
Leg cramps
Changes in libido
Urticaria, angioedema, anaphylactoid/anaphylactic reactions
Hypocalcemia
Exacerbation of asthma
Increased triglycerides

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