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CombiPatch

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CombiPatch

CombiPatch

SIDE EFFECTS

See BOXED WARNINGS, 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 0.05/0.14 mg per day1 n = 113
CombiPatch 0.05/0.25 mg per day1 n = 112
Placebo n = 107
Body as a Whole
46%
48%
41%
Abdominal pain
7%
6%
4%
Accidental injury
4%
5%
8%
Asthenia
8%
12%
4%
Back pain
11%
9%
5%
Flu syndrome
9%
5%
7%
Headache
18%
20%
20%
Pain
6%
4%
9%
Digestive
19%
23%
24%
Diarrhea
4%
5%
7%
Dyspepsia
1%
5%
5%
Flatulence
4%
5%
4%
Nausea
11%
8%
7%
Nervous
16%
28%
28%
Depression
3%
5%
9%
Insomnia
3%
6%
7%
Nervousness
3%
5%
1%
Respiratory
24%
38%
26%
Pharyngitis
4%
10%
2%
Respiratory disorder
7%
12%
7%
Rhinitis
7%
13%
9%
Sinusitis
4%
9%
9%
Skin and Appendages
8%
17%
16%
Application site reaction
2%
6%
4%
Urogenital
54%
63%
28%
Breast pain
25%
31%
7%
Dysmenorrhea
20%
21%
5%
Leukorrhea
5%
5%
3%
Menstrual Disorder
6%
12%
2%
Papanicolaou Smear Suspicious
8%
4%
5%
Vaginitis
6%
13%
5%
1 Represents 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 0.05/0.14 mg per day1 n = 325
CombiPatch 0.05/0.25 mg per day1 n = 312
Vivelle 0.05 mg per day n = 318
Body as a Whole
61%
60%
59%
Abdominal pain
12%
14%
16%
Accidental injury
10%
11%
8%
Asthenia
10%
13%
11%
Back pain
15%
14%
13%
Flu syndrome
14%
10%
7%
Headache
25%
17%
21%
Infection
5%
3%
3%
Pain
19%
15%
13%
Digestive
42%
32%
31%
Constipation
2%
5%
3%
Diarrhea
14%
9%
7%
Dyspepsia
8%
6%
5%
Flatulence
7%
5%
6%
Nausea
8%
12%
11%
Tooth Disorder
6%
4%
1%
Metabolic and Nutritional Disorders
12%
13%
11%
Peripheral edema
6%
6%
5%
Musculoskeletal
17%
17%
15%
Arthralgia
6%
6%
5%
Nervous
33%
30%
28%
Depression
8%
9%
8%
Dizziness
6%
7%
5%
Insomnia
8%
6%
4%
Nervousness
5%
6%
3%
Respiratory
45%
43%
40%
Bronchitis
5%
3%
4%
Pharyngitis
9%
9%
8%
Respiratory disorder
13%
9%
13%
Rhinitis
19%
22%
17%
Sinusitis
10%
12%
12%
Skin and Appendages
38%
37%
31%
Acne
4%
5%
4%
Application site reaction
20%
23%
17%
Rash
6%
5%
3%
Urogenital
71%
79%
74%
Breast Enlargement
2%
7%
2%
Breast pain
34%
48%
40%
Dysmenorrhea
30%
31%
19%
Leukorrhea
10%
8%
9%
Menorrhagia
2%
5%
9%
Menstrual Disorder
17%
19%
14%
Vaginal hemorrhage
3%
6%
12%
Vaginitis
9%
13%
13%
1 Represents milligrams of estradiol/NETA delivered daily by each system

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

1. 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.

2. Breasts

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

3. Cardiovascular

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

4. Gastrointestinal

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

5. Skin

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

6. Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

7. Central nervous system

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

8. Miscellaneous

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

Read the CombiPatch (estradiol, norethindrone acetate transdermal system) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex; and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III; decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.

2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.

3. Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).

4. Increased plasma HDL and HDI2 subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.

5. Impaired glucose tolerance.

6. Reduced response to metyrapone test.

Last reviewed on RxList: 10/5/2006
This monograph has been modified to include the generic and brand name in many instances.

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CombiPatch - User Reviews

CombiPatch User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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