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Femhrt (Norethindrone / Ethinyl Estradiol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Femhrt (Norethindrone / Ethinyl Estradiol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (6)
Disability (2)

Reports by Reaction Type

Hypertension (5)Contusion (3)Fall (3)Femur Fracture (2)Drug Interaction (2)Cyst (2)Limb Crushing Injury (2)Speech Disorder (2)Balance Disorder (2)Palpitations (2)DRY Mouth (2)Hallucination (2)

Possible Femhrt side effects in 59 year old female

Reported by a physician from United States on 2012-03-02

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

Reactions: Contusion, Femur Fracture, Joint Hyperextension, Hand Fracture, Cyst, Loss of Consciousness, Breast Cyst, Tongue Disorder, DRY Mouth, Muscle Injury, Cervical Spinal Stenosis, LOW Turnover Osteopathy, Muscle Spasms, Pain in Extremity, Laceration, Bursitis, Stress, Seasonal Allergy, Stress Fracture, Osteoporosis, Haemorrhage, Drug Interaction, Fracture Nonunion, Fall, Periodontitis, 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, Tooth Disorder, Hypertension

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Estrace

Femhrt

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

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

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

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



Possible Femhrt side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-01-29

Patient: 62 year old female

Reactions: Hypertension

Drug(s) suspected as cause:
Femhrt
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01

Other drugs received by patient: Lipitor; Methotrexate



Possible Femhrt side effects 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

Drug(s) suspected as cause:
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



Possible Femhrt side effects 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

Drug(s) suspected as cause:
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 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

Drug(s) suspected as cause:
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 in female

Reported by a consumer/non-health professional from United States on 2011-10-24

Patient: female

Reactions: Contusion, Oropharyngeal Pain, Transferrin Saturation Decreased, Fall, Gastric Ulcer, Weight Increased, Arthropathy, Incontinence, Fatigue, Fibromyalgia, Onychoclasis, Irritable Bowel Syndrome, Adrenal Insufficiency, Dizziness, Bone Disorder, Adhesion, Nasal Disorder, Gastrooesophageal Reflux Disease, Abdominal Pain Lower, Breast Discharge, Anaemia, Iron Deficiency, Pyloric Stenosis, Thermal Burn, Sleep Disorder, Presyncope, Vitamin D Decreased, Impaired Gastric Emptying, Inflammatory Bowel Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Celexa

Entocort EC
    Dosage: daily
    Administration route: Oral

Femhrt

Flector
    Dosage: as needed

Iron

Multi-Vitamin

Nexium
    Dosage: two times a day
    Administration route: Oral

Tramadol HCL

Valtrex

Vitamin D
    Dosage: as needed

Xanax

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