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Combipatch (Estradiol / Norethindrone Acetate) - 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.

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
CombiPatch ®
0.05/0.14
mg per day1
CombiPatch ®
0.05/0.25
mg per day1
Placebo
n=113 n=112 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%
1Represents milligrams of estradiol/NETA delivered daily by each system.

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

Postmarketing Experience

The following additional adverse reactions have been identified during postapproval 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, paraesthesia.

Miscellaneous

Angioedema, hypersensitivity, weight increased.

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.



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: 2014-08-04

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