Combipatch Side Effects
Please note - some side effects for Combipatch may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Combipatch - for the consumer
CombiPatch Patch (Bi-weekly)
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using CombiPatch Patch (Bi-weekly):
Seek medical attention right away if any of these SEVERE side effects occur when using CombiPatch Patch (Bi-weekly):Back pain; diarrhea; headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; runny or stuffy nose; stomach pain, cramps, or bloating; vomiting; weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf pain or tenderness; changes in vision or speech (eg, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent breast pain; severe or unusual vaginal bleeding; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.
For the professional
CombiPatch
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.
| 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 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.
| 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 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.
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.
TopMore resources:
Activella - Includes detailed dosage instructions.
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