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둘록세틴염산염과립

Duloxetine Hydrochloride Granules

원료 코드 M258601 국내 제품 2개 (단일제 2 · 복합제 0) DUR 성분 D000890

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

⚠️ DUR 안전사용 기준

  • 🧒 연령금기 18세 미만 소아 및 18세 미만의 청소년의 주요우울장애의 치료에는 사용해서는 안 됨.만 7세에서 17세까지의 주요우울장애 환자에서 플루옥세틴 군보다 이상사례(주로 오심)로 인한 중단 및 자살행동 높음.(정제/캡슐)
  • 🔁 효능군중복 효능군: 정신신경용제 · SNRI

이 성분만 든 제품 (단일제 2)

듀로센캡슐30밀리그램 (둘록세틴염산염) 사진 듀로센캡슐30밀리그램 (둘록세틴염산염) 유니메드제약(주)· 정신신경용제· 176.47밀리그램· 2015년 허가 전문듀로센캡슐60밀리그램 (둘록세틴염산염) 사진 듀로센캡슐60밀리그램 (둘록세틴염산염) 유니메드제약(주)· 정신신경용제· 352.94밀리그램· 2015년 허가 전문

병용금기 성분 (3)

아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).

상대 성분이유
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🌐 해외(미국) 정보 — 둘록세틴염산염과립

미국 FDA·NLM 자료 · 2026-10-01 기준

이 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)

Duloxetine delayed-release capsules is indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in adults ( 1 ) Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1 ) Chronic musculoskeletal pain in adults ( 1 )

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 )

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

The use of MAOIs intended to treat psychiatric disorders with Duloxetine delayed-release capsules or within 5 days of stopping treatment with Duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4) ]. Starting Duloxetine delayed-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9) and Warnings and Precautions (5.4) ]. Concomitant use of an MAOI antidepressant with Duloxetine delayed-release capsules is contraindicated Use of Duloxetine delayed-release capsules within 14 days of stopping an MAOI antidepressant is contraindicated In linezolid- or intravenous …

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue Duloxetine delayed-release capsules in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur ( 5.3 ) Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue Duloxetine delayed-release capsules and serotonergic agents ( 5.4 ) Increased Risk of Bleeding : May increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk ( 5.5 , 7.4 , 8.1 ) Severe Skin Reactions : Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur; Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified ( 5.6 ) Activation of Mania or Hypomania : Prior to initiating, screen patients for personal or family history of bipolar disorder, mania, or hypomania ( 5.8 ) Angle-Closure Glaucoma : Has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.9 ) Seizures : Prescribe with care in patients with a …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data ) . There are risks associated with untreated depression and fibromyalgia in pregnancy, and with exposure to SNRIs and SSRIs, including Duloxetine delayed-release capsules, during pregnancy (see Clinical Considerations ). In rats and rabbits treated with duloxetine during the period of …

미국 제품명 Cymbalta

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 186,795건 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 오심nausea17,923
  2. 2 피로fatigue15,983
  3. 3 약효 없음drug ineffective14,130
  4. 4 두통headache13,689
  5. 5 어지러움dizziness13,379
  6. 6 통증pain12,375
  7. 7 설사diarrhoea10,019
  8. 8 적응증 외 사용off label use9,952
  9. 9 불면증insomnia9,796
  10. 10 불안anxiety9,677
  11. 11 구토vomiting8,511
  12. 12 압박depression8,343

미국 리콜 기록

FDA 리콜(회수) 기록 29건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2026.06.17 · 2등급 · Breckenridge Pharmaceutical, Inc. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • 2026.06.17 · 2등급 · Breckenridge Pharmaceutical, Inc. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
  • 2026.06.10 · 2등급 · Asclemed USA Inc. CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
  • 2026.05.13 · 2등급 · Ajanta Pharma Ltd. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
  • 2026.05.13 · 2등급 · Ajanta Pharma Ltd. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

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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