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The following serious adverse reactions are discussed elsewhere in the labeling:

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

Clinical Trials 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 practice.

Adverse reactions reported by ≥ 5 percent of subjects in controlled clinical studies of femhrt are shown in Table 1.

Table 1: Associated Adverse Reactions Reported by ≥ 5 Percent of Subjects by Body Systema

BODY SYSTEM/Adverse Reaction Placebo
N = 247
Number (Percent) of Subjects
femhrt 0.5/2.5
N = 244
femhrt 1/5
N = 258
BODY AS A WHOLE 23 (12.8) 30 (16.9) 30 (15.7)
  Edema - Generalized 10 (4.0) 12 (4.9) 11 (4.3)
  Headache 12 (4.9) 14 (5.7) 16 (6.2)
DIGESTIVE SYSTEM 8 (4.4) 17 (9.6) 25 (13.1)
  Abdominal Pain 3 (1.2) 13 (5.3) 14 (6.8)
UROGENITAL SYSTEM 20 (11.1) 34 (19.2) 45 (23.6)
  Breast Pain 9 (3.6) 22 (9.0) 20 (7.8)
aThe total number of subjects for each body system may be less than the number of subjects with AEs in that body system because a subject may have had more than one AE per body system

Postmarketing Experience

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

Genitourinary System

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; 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; uterine cancer; vaginal hemorrhage; ovarian cyst; irregular menstruation; metrorrhagia; menorrhagia; dysmenorrhea; uterine enlargement.

Breasts

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

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; thrombosis; chest pain; myocardial infarction; cerebrovascular accident (stroke); transient ischemic attack; hemiparesis; increase in blood pressure; irregular heart rate; palpitations; dyspnea.

Gastrointestinal

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

Skin

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

Eyes

Retinal vascular thrombosis; visual impairment; intolerance to contact lenses.

Central Nervous System (CNS)

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

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; back pain; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; blood glucose abnormal; fatigue; myalgia; hypersensitivity.