FEMHRT SIDE EFFECTS
- Generic Name: norethindrone acetate, ethinyl estradiol
- Brand Name: Femhrt
- Drug Class: Contraceptives, Oral, Estrogens/Progestins
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders.
- Malignant Neoplasms.
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 System *
| BODY SYSTEM/ Adverse Reaction | Number (Percent) of Subjects | ||
| Placebo N = 247 |
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) |
| * The 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.
SRC: NLM .