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Estradiol / norethindrone topical Side Effects

Applies to estradiol/norethindrone topical: topical film extended release


Genitourinary side effects including breast pain (25% to 31%), dysmenorrhea (20% to 21%), vaginitis (6% to 13%), menstrual disorder (6% to 12%), suspicious Papanicolaou smear (4% to 8%), and leukorrhea (5%). Postmarketing side effects include endometrial hyperplasia, endocervical polyp, uterine leiomyomata, fallopian tube cyst, uterine spasms, and breast cancer.[Ref]


Respiratory side effects including rhinitis (7% to 13%), respiratory disorder (7% to 12%), pharyngitis (4% to 10%), and sinusitis (4% to 9%) were reported.[Ref]


Gastrointestinal side effects including nausea (8% to 11%), abdominal pain (6% to 7%), diarrhea (4% to 5%), flatulence (4% to 5%), and dyspepsia (1% to 5%) were reported.[Ref]


Local side effects including reaction at the application site (2% to 6%) has been reported.[Ref]


General side effects including headache (18% to 20%), asthenia (8% to 12%), back pain (9% to 11%), flu syndrome (5% to 9%), pain (4% to 6%), and accidental injury (4% to 5%) have been reported. Postmarketing side effects include increased weight.[Ref]


Psychiatric side effects including nervousness (3% to 6%) and depression (3% to 6%) have been reported.[Ref]


Hypersensitivity side effects include postmarketing reports of angioedema and hypersensitivity.


Cardiovascular side effects include postmarketing reports of hypertension and varicose veins.


Dermatologic side effects include postmarketing reports of skin discoloration.


Hepatic side effects include postmarketing reports of jaundice cholestatic, cholelithiasis, gall bladder disorder, and increased transaminases.

Nervous system

Nervous system side effects include postmarketing reports of affect lability, libido disorder, migraine, vertigo, and paraesthesia.


1. "Product Information. CombiPatch (estradiol-norethindrone topical)." Rhone-Poulenc Rorer, Collegeville, PA.

Some side effects of estradiol / norethindrone topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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