August 1, 2015
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CombiPatch

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CombiPatch




Side Effects
Interactions

SIDE EFFECTS

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.

Table 9: All Adverse Reactions Regardless of Relationship Reported at a Frequency of Greater than or Equal to 5 Percent with CombiPatch

  VASOMOTOR SYMPTOM STUDIES Placebo
n=107
CombiPatch 0.05/0.14 mg per day†
n=113
CombiPatch 0.05/0.25 mg per day†
n=112
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%
†Represents milligrams of estradiol/NETA delivered daily by each system.
*Application site reactions includes localized bleeding, bruising, burning, discomfort, dryness, eczema, edema, erythema, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, skin discoloration, skin pigmentation, swelling, urticaria, and vesicles.

Table 10: All Adverse Reactions Regardless of Relationship Reported at a Frequency of Greater than or Equal to 5 Percent with CombiPatch

  ENDOMETRIAL HYPERPLASIA STUDIES Vivelle 0.05 mg per day
n=318
CombiPatch 0.05/0.14 mg per day†
n=325
CombiPatch 0.05/0.25 mg per day†
n=312
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%
†Represents milligrams of estradiol/NETA delivered daily by each system.
*Application site reactions includes localized bleeding, bruising, burning, discomfort, dryness, eczema, edema, erythema, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, skin discoloration, skin pigmentation, swelling, urticaria, and vesicles.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of CombiPatch. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Endometrial hyperplasia, endocervical polyp, uterine leiomyomata, fallopian tube cyst, uterine spasms.

Breast

Breast cancer.

Cardiovascular

Hypertension, varicose veins.

Gastrointestinal

Jaundice cholestatic, cholelithiasis, gall bladder disorder, transaminases increased.

Skin

Skin discoloration.

Central Nervous System

Affect lability, libido disorder, migraine, vertigo, paresthesia.

Miscellaneous

Angioedema, hypersensitivity, weight increased.

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

DRUG INTERACTIONS

Drug-Laboratory Test 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 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. Women 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], SHBG), leading to increased circulating corticosteroids and sex steroids, respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
  4. Increased plasma high density lipoprotein (HDL) and HDL-2 subfraction concentrations, reduced low density lipoprotein (LDL) cholesterol concentration, increased triglycerides levels.
  5. Impaired glucose tolerance.

Last reviewed on RxList: 5/27/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions

CombiPatch - User Reviews

CombiPatch User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication CombiPatch sorted by most helpful. Patient Discussions FAQs

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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