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

 
 



ADVERSE REACTIONS

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 System 1  

BODY SYSTEM/
Adverse Reaction 

 Number (Percent) of Subjects
 Placebo  femhrt 0.5/2.5  femhrt 1/5 
 N = 247  N = 244  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)

1 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.



REPORTS OF SUSPECTED FEMHRT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Femhrt. The information is not vetted and should not be considered as verified clinical evidence.

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



See index of all Femhrt side effect reports >>

Drug label data at the top of this Page last updated: 2014-02-04

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