Femhrt (Norethindrone Acetate / Ethinyl Estradiol) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

See BOXED WARNING, 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.

Adverse events reported in controlled clinical studies of femhrt are shown in Table 6 below.

Table 6.

All Treatment-Emergent Adverse Events Reported at a Frequency of ≥5% of Patients with femhrt
BODY SYSTEM/ Adverse Event	Percent of Patients (%)
	Placebo	femhrt 0.5/2.5	femhrt 1/5
	N = 247	N = 244	N = 258
BODY AS A WHOLE	40.1	38.5	39.5
Headache	14.6	15.2	18.2
Back Pain	5.3	5.3	4.7
Viral Infection	7.7	8.6	7.0
DIGESTIVE SYSTEM	24.4	30.5	33.0
Nausea and/or Vomiting	5.3	5.3	7.4
Abdominal Pain	4.5	10.2	8.1
Dyspepsia	2.0	5.3	3.1
Diarrhea	3.6	5.7	3.9
MUSCULOSKELETAL SYSTEM	21.7	20.3	20.4
Arthralgia	6.9	2.9	5.8
Myalgia	8.5	8.6	7.8
PSYCHOBIOLOGIC FUNCTION	8.3	7.9	14.1
Nervousness	1.6	1.6	5.4
Depression	3.6	3.7	5.8
RESPIRATORY SYSTEM	37.2	33.9	35.6
Rhinitis	15.4	12.7	15.1
Sinusitis	9.7	9.4	8.1
UROGENITAL SYSTEM	25.0	31.6	40.8
Breast Pain	5.3	9.0	8.1
Urinary Tract Infection	3.2	3.7	6.2
Vaginitis	4.9	4.5	5.4

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; 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.

2. Breasts

Tenderness, enlargement, pain, nipple 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; cholestatic jaundice; pancreatitis, enlargement of hepatic hemangiomas; bloating, abdominal cramps; increased incidence of gallbladder disease.

5. Skin

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

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.

REPORTS OF SUSPECTED FEMHRT SIDE EFFECTS / ADVERSE REACTIONS

Possible Femhrt side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-11-23

Patient: 60 year old female weighing 73.9 kg (162.6 pounds)

Reactions: Dyspnoea, Chest Discomfort, Sensation of Heaviness, Hypohidrosis, Speech Disorder, Palpitations, Balance Disorder, Ageusia, Oedema Peripheral, Visual Impairment, Anosmia, Feeling Abnormal, Hypertension, Sluggishness, Hallucination

Adverse event resulted in: hospitalization

Suspect drug(s):
Femhrt
    Dosage: see image
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2011-04-01
    End date: 2011-04-01

Femhrt
    Dosage: see image
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2011-04-01
    End date: 2011-04-01

Femhrt
    Dosage: see image
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2004-01-01
    End date: 2011-04-01

Femhrt
    Dosage: see image
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2011-09-26

Other drugs received by patient: Centrum (Ascorbic Acid, Betacarotene, Colecalciferol, Folic Acid, Mine; Fish OIL (Fish Oil); Lipitor; Caltrate (Calcium Carbonate); Lisinopril (Lisinopril Dihydrate)

Possible Femhrt side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-12-09

Patient: 60 year old female weighing 73.9 kg (162.6 pounds)

Reactions: Hypohidrosis, Speech Disorder, Balance Disorder, Palpitations, Oedema Peripheral, Hallucination, Dyspnoea, Chest Discomfort, Sensation of Heaviness, Dysgeusia, Ageusia, Visual Impairment, Anosmia, Parosmia, Hypertension, Feeling Abnormal, Sluggishness

Adverse event resulted in: hospitalization

Suspect drug(s):
Femhrt
    Dosage: 5/1000 ug, qd: 5/100 ug, qod for 1 week: 5/1000 ug, every 2 days for 1 week: 2.5/500 ug, qd, oral
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2004-01-01
    End date: 2011-04-01

Femhrt
    Dosage: 5/1000 ug, qd: 5/100 ug, qod for 1 week: 5/1000 ug, every 2 days for 1 week: 2.5/500 ug, qd, oral
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2011-04-01
    End date: 2011-04-01

Femhrt
    Dosage: 5/1000 ug, qd: 5/100 ug, qod for 1 week: 5/1000 ug, every 2 days for 1 week: 2.5/500 ug, qd, oral
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2011-04-01
    End date: 2011-04-01

Femhrt
    Dosage: 5/1000 ug, qd: 5/100 ug, qod for 1 week: 5/1000 ug, every 2 days for 1 week: 2.5/500 ug, qd, oral
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2011-09-26

Other drugs received by patient: Lipitor; Centrum (Ascorbic Acid, Betacarotene, Colecalciferol, Folic Acid, Mine; Fish OIL; Caltrate (Calcium Carbonate); Lisinopril (Lisinopril Dihydrate)

Possible Femhrt side effects / adverse reactions in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-01-12

Patient: 59 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Femur Fracture, Contusion, Joint Hyperextension, Hand Fracture, Cyst, Loss of Consciousness, Breast Cyst, Tongue Disorder, Muscle Injury, DRY Mouth, Cervical Spinal Stenosis, LOW Turnover Osteopathy, Muscle Spasms, Pain in Extremity, Laceration, Bursitis, Stress, Seasonal Allergy, Stress Fracture, Haemorrhage, Osteoporosis, Drug Interaction, Periodontitis, Fracture Nonunion, Fall, Foot Fracture, Limb Crushing Injury, Bone Loss, Fibrocystic Breast Disease, Malignant Melanoma, Blood Cholesterol Increased, Humerus Fracture, Tooth Fracture, Breast Disorder, Dental Caries, Bruxism, Meniscus Lesion, Osteoarthritis, Gingival Recession, Impaired Healing, Spinal Osteoarthritis, Hypertension, Tooth Disorder

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Estrace

Femhrt

Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 1996-01-01
    End date: 2001-01-01

Fosamax
    Administration route: Oral
    Start date: 2003-05-01
    End date: 2005-04-01

Fosamax
    Administration route: Oral
    Start date: 2001-01-01
    End date: 2002-04-01

Other drugs received by patient: Premarin; Vioxx; Calcium (Unspecified); Progesterone