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Combipatch (Estradiol / Norethindrone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Combipatch (Estradiol / Norethindrone) 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 (24)
Life Threatening Events (1)

Reports by Reaction Type

Product Adhesion Issue (5)Hot Flush (4)Breast Mass (4)Breast Tenderness (4)Breast Cyst (3)Malaise (3)Breast Cancer (3)Incorrect Dose Administered (3)Pain (2)Headache (2)Fall (2)Application Site Pruritus (2)

Possible Combipatch side effects in female

Reported by a physician from South Africa on 2012-08-17

Patient: female

Reactions: Headache, Application Site Rash, Crying, Cryptococcosis

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in 63 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-06

Patient: 63 year old female

Reactions: Haemorrhage, Drug Intolerance, Product Adhesion Issue

Drug(s) suspected as cause:
Combipatch
    Dosage: 1 df, q96h
    Indication: Hormone Replacement Therapy

Combipatch
    Dosage: unk ukn, unk
    Start date: 2012-07-27

Systen Conti



Possible Combipatch side effects in female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-01

Patient: female

Reactions: Blood Pressure Increased, Syncope, Hypertensive Crisis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a physician from United States on 2012-07-09

Patient: female, weighing 63.0 kg (138.7 pounds)

Reactions: Mammogram Abnormal, Breast Mass, Hormone Level Abnormal

Drug(s) suspected as cause:
Combipatch
    Indication: Hormone Replacement Therapy

Combipatch
    Dosage: 1 df, 0.05/0.14 mg
    Indication: Osteoporosis
    Start date: 2009-03-01
    End date: 2012-05-01

Other drugs received by patient: Fish OIL; Multi-Vitamins; Vitamin D; Docusate Sodium; Calcium D3; Chlorthalidone; Probiotics; Losartan Potassium; Cozaar



Possible Combipatch side effects in female

Reported by a physician from United States on 2012-06-26

Patient: female, weighing 97.7 kg (214.9 pounds)

Reactions: Menstruation Irregular, Pain, Postmenopausal Haemorrhage, Product Adhesion Issue, Cervical Polyp

Drug(s) suspected as cause:
Combipatch
    Dosage: 1 df, qw2

Combipatch
    Dosage: 1 df, qw2
    Start date: 2011-09-23
    End date: 2012-03-06

Combipatch
    Dosage: 0.05/0.25 mg

Other drugs received by patient: Fish OIL; Calcium W / Magnesium; Multivitamin Preparations with OR W / O Mineral



Possible Combipatch side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: female

Reactions: Breast Tenderness

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in 53 year old female

Reported by a physician from Brazil on 2012-06-01

Patient: 53 year old female

Reactions: Blood Pressure Increased, Abdominal Pain, Malaise, Hot Flush, Incorrect Dose Administered, Constipation, Tension, Nervousness

Drug(s) suspected as cause:
Combipatch
    Dosage: 1 df, qw2
    Indication: Hormone Replacement Therapy

Combipatch
    Dosage: 1 df,every days



Possible Combipatch side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: female

Reactions: Breast Cyst, Breast Tenderness, Breast Mass

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female

Reactions: Breast Cyst, Breast Tenderness, Breast Mass

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in 50 year old female

Reported by a physician from United States on 2012-05-09

Patient: 50 year old female

Reactions: Alopecia, Uterine Haemorrhage

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a physician from United States on 2012-04-12

Patient: female

Reactions: Menorrhagia

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-24

Patient: female, weighing 97.7 kg (214.9 pounds)

Reactions: Menstruation Irregular, Postmenopausal Haemorrhage, Product Adhesion Issue, Cervical Polyp

Drug(s) suspected as cause:
Combipatch
    Dosage: 1 df, qw2

Combipatch
    Dosage: 1 df, qw2
    Start date: 2011-09-23
    End date: 2012-03-06

Combipatch
    Dosage: 0.05/0.25 mg

Other drugs received by patient: Calcium W / Magnesium; Fish OIL; Multivitamin Preparations with OR W / O Mineral



Possible Combipatch side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-19

Patient: female

Reactions: Chest Discomfort, Malaise, Hot Flush

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-08

Patient: female

Reactions: Malaise, Chest Discomfort, Hot Flush

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-24

Patient:

Reactions: Skin Irritation

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-23

Patient: female, weighing 90.7 kg (199.5 pounds)

Reactions: Night Sweats, Contusion, Seborrhoeic Dermatitis, Urticaria, Urinary Incontinence, Blepharitis, Vaginal Haemorrhage, Mammogram Abnormal, Colonic Polyp, Smear Cervix Abnormal, Hot Flush, Upper Respiratory Tract Infection, Vitamin B12 Deficiency, Dyspepsia, Nodule, Epistaxis, Back Pain, Breast Cancer, Ventricular Extrasystoles, Cardiac Murmur, Pain in Extremity, Autonomic Nervous System Imbalance, Nasal Congestion, Breast Calcifications, Paraesthesia, Hirsutism, Diverticulum, Post-Traumatic Stress Disorder, Sleep Disorder, Acute Sinusitis, Helicobacter Gastritis, Bunion, Folliculitis, Adverse Drug Reaction, Cervicitis, Constipation, Abdominal Pain Upper, Cystocele, Lymphadenitis, Conjunctivitis Allergic, Dyspnoea Exertional, Fatigue, Chest Pain, Cholecystitis, Exostosis, Vulvovaginal Mycotic Infection, Supraventricular Extrasystoles, Febrile Neutropenia, Rhinorrhoea, Rash, Biopsy Breast, Hyperlipidaemia, Anxiety, Atrophic Vulvovaginitis, Syncope, Arthralgia, Diarrhoea, Bronchitis, Hypertension, Arthritis

Drug(s) suspected as cause:
Climara

Combipatch
    Indication: Menopause

Estraderm
    Dosage: 0.1 mg, unk
    Indication: Menopause
    Start date: 1987-01-01
    End date: 2004-08-01

Medroxyprogesterone
    Dosage: unk ukn, unk

Provera
    Dosage: 2.5 mg, unk
    Indication: Menopause
    Start date: 1995-01-01
    End date: 1997-01-01

Other drugs received by patient: Femara; Paxil; Estrogens; Wellbutrin; Zithromax; Zoloft; Metronidazole; Percocet; Valtrex; Tussi-Organidin DM NR; Cyanocobalamin



Possible Combipatch side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-01-13

Patient: 62 year old female

Reactions: Incorrect Dose Administered, Rotator Cuff Syndrome

Drug(s) suspected as cause:
Combipatch

Other drugs received by patient: Glucosamine W / Chondroitin / MSM; Lipitor; Aspirin; Vitamin D; Omega; Calcium



Possible Combipatch side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-01-09

Patient: 62 year old female

Reactions: Incorrect Dose Administered, Rotator Cuff Syndrome

Drug(s) suspected as cause:
Combipatch

Other drugs received by patient: Vitamin D; Omega; Aspirin; Calcium Acetate; Glucosamine W / Chondroitin / MSM; Lipitor



Possible Combipatch side effects in 56 year old female

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

Patient: 56 year old female, weighing 107.5 kg (236.5 pounds)

Reactions: Scratch, Product Quality Issue, Pruritus, Application Site Burn, Product Adhesion Issue, Application Site Pruritus

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a physician from United States on 2011-12-02

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Lymphadenopathy, Uterine Leiomyoma, Oedema Peripheral, Arteriosclerosis, Breast Pain, Breast Cancer, Cellulitis, Cardiac Murmur, Osteopenia, Hirsutism, Cerebral Small Vessel Ischaemic Disease, Metastases To Spine, Uterine Disorder, Scar, Bone Pain, Fall, Metastases To Lymph Nodes, Intervertebral Disc Disorder, Dizziness, Oedema, Abdominal Distension, Metastases To Peritoneum, Lymphoedema, Lymph Node Fibrosis, Breast Disorder, Musculoskeletal Pain, Cerebral Atrophy, Osteoarthritis, Anxiety, Mitral Valve Incompetence, Metastases To Bone, Deep Vein Thrombosis

Drug(s) suspected as cause:
Combipatch
    Dosage: 50/140mcg
    Indication: Menopause
    Start date: 1998-12-19

Estradiol
    Dosage: 1 mg, unk

Estradiol
    Dosage: 0.5mg
    Indication: Menopause
    Start date: 1999-03-12

Gynodiol
    Dosage: 1 mg, unk

Gynodiol
    Dosage: 0.5 mg, unk
    Indication: Hormone Replacement Therapy

Prempro
    Dosage: 2.5mg
    Indication: Menopause
    Start date: 1998-03-13

Prometrium
    Dosage: 100mg
    Indication: Hormone Replacement Therapy
    Start date: 1998-12-30

Vagifem
    Dosage: 25 ug, unk

Vivelle
    Dosage: 0.05mg
    Indication: Hormone Replacement Therapy
    Start date: 1998-12-30

Vivelle
    Dosage: 0.025mg
    Administration route: Topical

Vivelle
    Dosage: .075 mg, unk

Other drugs received by patient: Aldactone; Wellbutrin; Femara; Remeron; Paxil; Dyazide; Spironolactone; Nolvadex; Prozac; Zyban; Xenical; Miacalcin; Aromasin; Alprazolam; Hydrochlorothiazide; Proventil; Zyrtec; Buspar



Possible Combipatch side effects in 47 year old female

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

Patient: 47 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Impaired Healing, Application Site Inflammation, Product Adhesion Issue, Application Site Pain, Application Site Irritation, Application Site Pruritus

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-20

Patient: female, weighing 95.2 kg (209.5 pounds)

Reactions: Osteoporosis, Perivascular Dermatitis, Radiation Skin Injury, Headache, Fall, Fibrocystic Breast Disease, Breast Cyst, Skin Lesion, Breast Cancer, Breast Pain, Breast Disorder, Post Herpetic Neuralgia, Breast Mass, Osteopenia, Rash, Breast Calcifications, Paraesthesia, Hyperlipidaemia, Burning Sensation, Breast Haemorrhage, Arthralgia, Nuclear Magnetic Resonance Imaging Abnormal, Breast Inflammation, Breast Fibrosis, Influenza Like Illness

Drug(s) suspected as cause:
Combipatch
    Dosage: 0.5 mg, unk
    Indication: Menopause
    Start date: 2001-01-24
    End date: 2005-01-03

Premarin
    Administration route: Oral
    Indication: Menopause
    Start date: 1995-01-01
    End date: 1997-12-01

Prempro
    Administration route: Oral
    Indication: Menopause
    Start date: 1998-01-01
    End date: 2000-12-01

Provera
    Administration route: Oral
    Indication: Menopause
    Start date: 1995-01-01
    End date: 1997-12-01

Other drugs received by patient: Lipitor; Atenolol



Possible Combipatch side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2011-10-20

Patient: 50 year old female, weighing 81.2 kg (178.6 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Combipatch



Possible Combipatch side effects in female

Reported by a individual with unspecified qualification from United States on 2011-10-11

Patient: female

Reactions: Polyp, Pain, Stress, Vaginal Haemorrhage, Breast Swelling, Breast Tenderness, Hypertension, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combipatch

Other drugs received by patient: Claritin; Atenolol; Avalide; Paxil; Ambien; Tylenol-500; Nexium; Lipitor; Xanax

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