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 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 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 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
|
