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리라글루티드

Liraglutide

원료 코드 M266520 국내 제품 2개 (단일제 1 · 복합제 1) DUR 성분 D001294

🌐 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 - 임부에 대한 안전성 미확립- 동물실험에서 생식독성 보고- 동물실험 최고용량에서 초기 배아 사망이 근소하게 증가함. 임신 중기 투여는 모체 체중 및 태자 성장 감소를 초래하고, 랫드 늑골에서의 불분명한 영향 및 토끼에서의 골격 변이가 함께 나타남(용액주사제)
  • 🤰 임부금기 2등급 - 임부에 대한 안전성 미확립- 동물실험에서 생식독성 보고 - 암컷 랫드에서 1.0mg/kg/day에서 조기배아사의 증가가 나타남(용액주사제)
  • ⚖️ 용량주의 하루 최대 리라글루티드 3밀리그램 비만 및 과체중 환자 체중관리(용액주사제)
  • ⚖️ 용량주의 하루 최대 리라글루티드 1.8밀리그램 제2형 당뇨병(용액주사제)
  • 🔁 효능군중복 효능군: 당뇨병용제 · GLP-1 수용체 효능제(Glucagon-like peptide-1 receptor agonists)

이 성분만 든 제품 (단일제 1)

삭센다펜주6밀리그램 노보노디스크제약(주)· 따로 분류되지 않는 대사성 의약품· 6.0밀리그램· 2017년 허가 전문

다른 성분과 섞인 제품 (복합제 1)

목록 펼치기 줄토피플렉스터치주 노보노디스크제약(주)· 당뇨병용제· 3.6밀리그램· 2019년 허가 전문

🌐 해외(미국) 정보 — 리라글루티드

미국 FDA·NLM 자료 · 2026-10-04 기준

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

GLP-1 Receptor Agonist [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

Liraglutide Injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use : Liraglutide Injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide Injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus ( 1 ). Limitations of Use : Coadministration with other liraglutide-containing products is not recommended.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . Liraglutide is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of liraglutide and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide injection [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Liraglutide is contraindicated in patients with a: personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . serious hypersensitivity reaction to liraglutide or to any of the excipients in liraglutide injection. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with liraglutide injection [see Warnings and Precautions ( 5.7 )] . Patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. (4) Patients with a serious hypersensitivity reaction to liraglutide or any of the excipients in liraglutide injection. (4)

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including liraglutide. Discontinue if pancreatitis is suspected. ( 5.2 ) Never Share a Liraglutide Injection Pen Between Patients , even if the needle is changed. (5.3) Hypoglycemia : Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with liraglutide regardless of insulin and/or metformin use. Reduction in the dose of insulin secretagogues or insulin may be necessary. (5.4) Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) Severe Gastrointestinal Adverse Reactions : Use has been associated with gastrointestinal adverse reactions, sometimes severe. Liraglutide injection is not recommended in patients with severe gastroparesis. ( 5.6 ) Hypersensitivity Reactions : Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue liraglutide injection and promptly seek medical advice. ( 5.7 ) Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.8 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation : Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. Liraglutide injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day. In pregnant rabbits administered …

미국 제품명 Saxenda, Victoza

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 50,704건 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 오심nausea7,293
  2. 2 혈당 증가blood glucose increased4,092
  3. 3 구토vomiting3,600
  4. 4 설사diarrhoea3,461
  5. 5 췌장염pancreatitis2,355
  6. 6 식욕감퇴decreased appetite2,159
  7. 7 체중 감소weight decreased2,158
  8. 8 두통headache2,050
  9. 9 적응증 외 사용off label use1,888
  10. 10 피로fatigue1,684
  11. 11 약효 없음drug ineffective1,626
  12. 12 변비constipation1,618

미국 리콜 기록

FDA 리콜(회수) 기록 4건 중 최근 4건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2026.05.27 · 2등급 · Lupin Pharmaceuticals Inc. Presence of particulate matter: a white thread-like structure in the cartridge
  • 2021.04.21 · 2등급 · Novo Nordisk Inc Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
  • 2021.04.21 · 2등급 · Novo Nordisk Inc Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
  • 2021.04.21 · 1등급(심각) · Novo Nordisk Inc Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

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.

허가 취소·취하된 제품 1개 빅토자펜주6밀리그램 노보노디스크제약(주)· 당뇨병용제· 2010년 허가 유효기간만료