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
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) |
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.
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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
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