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Estradiol / norethindrone topical Side Effects

Applies to estradiol / norethindrone topical: topical film extended release

Genitourinary

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

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

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

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

General

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

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

Hypersensitivity

Hypersensitivity side effects include postmarketing reports of angioedema and hypersensitivity.

Cardiovascular

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

Dermatologic

Dermatologic side effects include postmarketing reports of skin discoloration.

Hepatic

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.

References

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

Not all side effects for estradiol / norethindrone topical may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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