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Furosemide

원료 코드 M040715 국내 제품 5개 (단일제 5 · 복합제 0) DUR 성분 D000798

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이 성분만 든 제품 (단일제 5)

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병용금기 성분 (2)

아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).

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미국 FDA·NLM 자료 · 2026-10-03 기준

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

Loop Diuretic [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs. (See DOSAGE AND ADMINISTRATION .)

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used). (See PRECAUTIONS, Drug Interactions . ) Pediatric Use: In premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA), …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Pregnancy Teratogenic Effects: Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4, and 8 times the maximal recommended human oral dose. There are no adequate and well-controlled studies in pregnant women. Furosemide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher fetal birth weights. The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. Furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest …

미국 제품명 Lasix

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 398,366건 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 호흡 곤란dyspnoea29,966
  2. 2 피로fatigue21,060
  3. 3 설사diarrhoea20,622
  4. 4 오심nausea19,261
  5. 5 급성 신장 손상acute kidney injury19,011
  6. 6 사망death18,744
  7. 7 낙상fall16,523
  8. 8 폐렴pneumonia16,482
  9. 9 쇠약asthenia15,491
  10. 10 어지러움dizziness15,214
  11. 11 저혈압hypotension15,153
  12. 12 약효 없음drug ineffective14,883

미국 리콜 기록

FDA 리콜(회수) 기록 7건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2026.04.29 · 2등급 · Leading Pharma, LLC CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
  • 2026.01.28 · 2등급 · Graviti Pharmaceuticals Private Limited Presence of Foreign Substance
  • 2017.02.01 · 2등급 · Roxane Laboratories, Inc. Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
  • 2015.10.21 · 3등급(경미) · Boehringer Ingelheim Roxane Inc CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
  • 2015.10.21 · 3등급(경미) · Boehringer Ingelheim Roxane Inc CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.

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.

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