노르에티스테론아세테이트

Norethisterone

원료 코드 M222945 국내 제품 1개 (단일제 0 · 복합제 1) DUR 성분 D000786

🌐 미국 FDA 자료(영문 라벨·부작용 보고·리콜)가 있습니다. 한국어는 AI 번역 참고용이니 원문을 함께 확인하세요. 해외 정보 보기

⚠️ DUR 안전사용 기준

  • 🤰 임부금기 1등급 신생여아 외부생식기의 남성화 가능성.(정제)
  • 🤰 임부금기 1등급 "에스트로겐 대체 요법에 의해 남녀 태아의 생식기관의 유전적 결함 증가. 훗날 여성의 경우 질선종, 자궁경부, 편평세포형성장애, 자궁암 위험 증가. 임부에 유방암 발생 증가 가능성. 임신중 여성호르몬제 복용시 선천성 심장기형 및 사지결손증 증가 보고. 동물실험에서 태자의 생식기이상, 기형유발 보고."(정제/유화주사제/용액용분말주사제/서방성현탁액용분말주사제/용액용동결건조분말주사제/현탁액용동결건조분말주사제/서방성현탁액용동결건조분말주사제/리포좀화현탁액용동결건조분말주사제/현탁액주사제/서방성현탁액성주사제/용액주사제/경피흡수제/서방성경피흡수제/전류조절형서방성경피흡수제)

이 성분만 든 제품 (단일제 0)

다른 성분과 섞인 제품 (복합제 1)

목록 펼치기 에디올정 명문제약(주)· 난포호르몬제 및 황체호르몬제· 0.5밀리그램· 2015년 허가 전문

🌐 해외(미국) 정보 — 노르에티스테론아세테이트

미국 FDA·NLM 자료 · 2026-10-07 기준

이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).

Progestin [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2. Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason. 2 Among couples who initiate use of a method (not necessarily for the first time), and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using …

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. Norethindrone tablets do not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1. Ectopic pregnancy The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this …

미국 제품명 Gallifrey, Emzahh, Incassia, Microgestin 1/20

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 18,178건 가운데 많이 적힌 증상입니다. 보고 수는 약 때문이라는 증거가 아니며, 많이 쓰는 약일수록 많아집니다. 증상 이름의 한국어는 AI 번역(참고용)이라 영어 원어를 함께 적었습니다.

  1. 1 오심nausea1,311
  2. 2 두통headache1,186
  3. 3 적응증 외 사용off label use1,010
  4. 4 약효 없음drug ineffective984
  5. 5 피로fatigue942
  6. 6 통증pain789
  7. 7 불안anxiety673
  8. 8 어지러움dizziness651
  9. 9 설사diarrhoea594
  10. 10 압박depression580
  11. 11 구토vomiting572
  12. 12 HOT FLUSH562

미국 리콜 기록

FDA 리콜(회수) 기록 12건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2026.06.24 · 2등급 · Glenmark Pharmaceuticals Inc., USA Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
  • 2024.02.21 · 3등급(경미) · Teva Pharmaceuticals USA, Inc Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
  • 2024.02.21 · 3등급(경미) · Teva Pharmaceuticals USA, Inc Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
  • 2022.02.09 · 3등급(경미) · Teva Pharmaceuticals USA Mislabeling
  • 2022.02.09 · 3등급(경미) · Teva Pharmaceuticals USA Mislabeling

출처: 미국 FDA openFDA(라벨·FAERS·리콜), 미국 국립의학도서관 RxNorm · DailyMed 원문 라벨. 한국어는 오픈드럭 서버 AI(gemma)가 자동 번역한 참고용(사람 검수 전)으로 오역이 있을 수 있으니 반드시 원문을 확인하세요.