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Prefest

Last reviewed on RxList: 11/20/2017
Prefest Side Effects Center

Last reviewed on RxList 11/20/2017

Prefest (estradiol/norgestimate) Tablets are a combination of female sex hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Prefest is also used to prevent osteoporosis. Prefest is available in generic form. Common side effects of Prefest include:

Prefest regimen consists of the daily dose of a single tablet containing 1 mg estradiol (pink color) for three days followed by a single tablet of 1 mg estradiol combined with 0.09 mg norgestimate (white color) for three days. This regimen is repeated continuously without interruption. Prefest may interact with St. John's wort, antibiotics, antidepressants, antifungals, barbiturates, heart or blood pressure medications, HIV/AIDS medicines, or seizure medications. Tell your doctor all medications and supplements you use. Prefest 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.

Our Prefest (estradiol/norgestimate) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Prefest Consumer Information

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • unusual vaginal bleeding (especially if you are past menopause);
  • 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;
  • stabbing chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;
  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet; or
  • a lump in your breast.

Less serious side effects may include:

  • mild stomach pain, bloating;
  • back pain, joint pain;
  • flu symptoms;
  • headache;
  • breast pain;
  • loss of scalp hair;
  • vaginal itching or discharge; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Prefest (Estradiol, Norgestimate)

Prefest Professional Information

SIDE EFFECTS

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.

Table 7: ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF DRUG RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH PREFEST

FOUR 12-MONTH CLINICAL TRIALS
  PREFEST (Estradiol and Norgestimate)
(N = 579) N (%)
Body as a Whole
Back pain 69 (12%)
Fatigue 32 (6%)
Influenza-like symptoms 64 (11%)
Pain 37 (6%)
Digestive System
Abdominal pain 70 (12%)
Flatulence 29 (5%)
Nausea 34 (6%)
Tooth disorder 27 (5%)
Musculoskeletal System
Arthralgia 51 (9%)
Myalgia 30 (5%)
Nervous System
Dizziness 27 (5%)
Headache 132 (23%)
Psychiatric Disorders
Depression 27 (5%)
Reproductive System
Breast pain 92 (16%)
Dysmenorrhea 48 (8%)
Vaginal bleeding (all) 52 (9%)
Vaginitis 42 (7%)
Resistance Mechanism Disorders
Viral infection 35 (6%)
Respiratory System
Coughing 28 (5%)
Pharyngitis 38 (7%)
Sinusitis 44 (8%)
Upper respiratory-tract infection 121 (21%)

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

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; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

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

Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.

Skin

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

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Read the entire FDA prescribing information for Prefest (Estradiol, Norgestimate)

Related Resources for Prefest

Read the Prefest User Reviews »

© Prefest Patient Information is supplied by Cerner Multum, Inc. and Prefest Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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