구연산타목시펜
Tamoxifen Citrate
원료 코드 M081968 국내 제품 4개 (단일제 4 · 복합제 0) DUR 성분 D000679
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이 성분만 든 제품 (단일제 4)
광고
병용금기 성분 (2)
아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).
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미국 FDA·NLM 자료 · 2026-10-02 기준이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
Metastatic Breast Cancer: Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer. Ductal Carcinoma in Situ (DCIS): In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED …
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer : Serious and life-threatening events associated with tamoxifen citrate in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY-Clinical Studies – Reduction in Breast Cancer Incidence In High Risk Women ). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen citrate vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen citrate vs 0.4 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen citrate vs 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen citrate versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen citrate to reduce their risk of developing breast cancer. The benefits of tamoxifen citrate outweigh its risks in women already diagnosed with breast cancer. *Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. …
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Tamoxifen citrate tablets are contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. Reduction in Breast Cancer Incidence in High Risk Women and Women with DCIS: Tamoxifen citrate tablets are contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
Effects in Metastatic Breast Cancer Patients: As with other additive hormonal therapy (estrogens and androgens), hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with tamoxifen citrate. If hypercalcemia does occur, appropriate measures should be taken and, if severe, tamoxifen citrate should be discontinued. Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma: An increased incidence of uterine malignancies has been reported in association with tamoxifen citrate treatment. The underlying mechanism is unknown, but may be related to the estrogen-like effect of tamoxifen citrate. Most uterine malignancies seen in association with tamoxifen citrate are classified as adenocarcinoma of the endometrium. However, rare uterine sarcomas, including malignant mixed mullerian tumors (MMMT), have also been reported. Uterine sarcoma is generally associated with a higher FIGO stage (III/IV) at diagnosis, poorer prognosis, and shorter survival. Uterine sarcoma has been reported to occur more frequently among long-term users (≥ 2 years) of tamoxifen citrate than non-users. Some of the uterine malignancies (endometrial carcinoma or uterine sarcoma) have been fatal. In the NSABP P-1 trial, among participants randomized to tamoxifen citrate there was a statistically significant increase in the incidence of endometrial cancer (33 cases of invasive endometrial cancer, compared to 14 cases among participants …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
See WARNINGS .
미국 제품명 SOLTAMOX
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 5,726건 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 피로fatigue395
- 2 오심nausea350
- 3 설사diarrhoea278
- 4 관절통arthralgia276
- 5 MALIGNANT NEOPLASM PROGRESSION266
- 6 통증pain247
- 7 구토vomiting229
- 8 호흡 곤란dyspnoea226
- 9 BREAST CANCER221
- 10 어지러움dizziness214
- 11 두통headache205
- 12 HOT FLUSH198
미국 리콜 기록
FDA 리콜 기록이 없습니다.
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.
