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Combipatch (Estradiol / Norethindrone Acetate Transdermal) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

See BOXED WARNING, WARNINGS and PRECAUTIONS.

      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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Table IV. All Treatment Emergent Study Events Regardless of Relationship Reported at a Frequency of ≥5% with CombiPatch®
VASOMOTOR SYMPTOM STUDIES
CombiPatch ® CombiPatch ® Placebo
0.05/0.14
mg per day1
n=113
0.05/0.25
mg per day1
n=112
n=107
Body as a Whole 46%48%41%
      Abdominal Pain7%6%4%
      Accidental Injury4%5%8%
      Asthenia8%12%4%
      Back Pain11%9%5%
      Flu Syndrome9%5%7%
      Headache18%20%20%
      Pain6%4%9%
Digestive 19%23%24%
      Diarrhea4%5%7%
      Dyspepsia1%5%5%
      Flatulence4%5%4%
      Nausea11%8%7%
Nervous 16%28%28%
      Depression3%5%9%
      Insomnia3%6%7%
      Nervousness3%5%1%
Respiratory 24%38%26%
      Pharyngitis4%10%2%
      Respiratory Disorder7%12%7%
      Rhinitis7%13%9%
      Sinusitis4%9%9%
Skin and Appendages 8%17%16%
      Application Site Reaction2%6%4%
Urogenital 54%63%28%
      Breast Pain25%31%7%
      Dysmenorrhea20%21%5%
      Leukorrhea5%5%3%
      Menstrual Disorder6%12%2%
      Papanicolaou Smear Suspicious8%4%5%
      Vaginitis6%13%5%

     1Represents milligrams of estradiol/NETA delivered daily by each system.

Table V. All Treatment Emergent Study Events Regardless of Relationship Reported at a Frequency of ≥5% with CombiPatch®
ENDOMETRIAL HYPERPLASIA STUDIES
CombiPatch® CombiPatch® Vivelle®
0.05/0.14
mg per day1
n=325
0.05/0.25
mg per day1
n=312
0.05
mg per day
n=318
Body as a Whole 61%60%59%
      Abdominal Pain12%14%16%
      Accidental Injury10%11%8%
      Asthenia10%13%11%
      Back Pain15%14%13%
      Flu Syndrome14%10%7%
      Headache25%17%21%
      Infection 5%3%3%
      Pain19%15%13%
Digestive 42%32%31%
      Constipation2%5%3%
      Diarrhea14%9%7%
      Dyspepsia8%6%5%
      Flatulence7%5%6%
      Nausea8%12%11%
      Tooth Disorder6%4%1%
Metabolic and Nutritional Disorders 12%13%11%
      Peripheral Edema6%6%5%
Musculoskeletal 17%17%15%
      Arthralgia6%6%5%
Nervous 33%30%28%
      Depression8%9%8%
      Dizziness6%7%5%
      Insomnia8%6%4%
      Nervousness5%6%3%
Respiratory 45%43%40%
      Bronchitis5%3%4%
      Pharyngitis9%9%8%
      Respiratory Disorder13%9%13%
      Rhinitis19%22%17%
      Sinusitis10%12%12%
Skin and Appendages 38%37%31%
      Acne4%5%4%
      Application Site Reaction20%23%17%
      Rash6%5%3%
Urogenital 71%79%74%
      Breast Enlargement2%7%2%
      Breast Pain34%48%40%
      Dysmenorrhea30%31%19%
      Leukorrhea10%8%9%
      Menorrhagia2%5%9%
      Menstrual Disorder17%19%14%
      Vaginal Hemorrhage3%6%12%
      Vaginitis9%13%13%

     1Represents milligrams of estradiol/NETA delivered daily by each system.

      The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

Genitourinary System

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, 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.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.



REPORTS OF SUSPECTED COMBIPATCH SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Combipatch side effects / adverse reactions 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

Suspect drug(s):
Combipatch



Possible Combipatch side effects / adverse reactions 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

Suspect drug(s):
Combipatch



Possible Combipatch side effects / adverse reactions 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

Suspect drug(s):
Combipatch



See index of all Combipatch side effect reports >>

Drug label data at the top of this Page last updated: 2006-10-13

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