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바레니클린옥살산염수화물

Varenicline Oxalate Hydrate

원료 코드 M265225 국내 제품 2개 (단일제 2 · 복합제 0)

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

이 성분만 든 제품 (단일제 2)

노코틴정1밀리그램(바레니클린옥살산염수화물) 사진 노코틴정1밀리그램(바레니클린옥살산염수화물) 한미약품(주)· 따로 분류되지 않고 치료를 주목적으로 하지않는 의약품· 2023년 허가 전문노코틴정0.5밀리그램(바레니클린옥살산염수화물) 사진 노코틴정0.5밀리그램(바레니클린옥살산염수화물) 한미약품(주)· 따로 분류되지 않고 치료를 주목적으로 하지않는 의약품· 2023년 허가 전문

🌐 해외(미국) 정보 — 바레니클린옥살산염수화물

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)

is indicated for use as an aid to smoking cessation treatment. CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking CHANTIX who continued to smoke. All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. When symptoms were reported, most were during CHANTIX treatment, but some were following discontinuation of CHANTIX therapy. These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the premarketing studies of CHANTIX. Advise patients and caregivers …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to CHANTIX. History of serious hypersensitivity or skin reactions to CHANTIX. ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

• Seizures: New or worsening seizures have been observed in patients taking CHANTIX. CHANTIX should be used cautiously in patients with a history of seizures or other factors that can lower the seizure threshold. ( 5.2 ) • Interaction with alcohol: Increased effects of alcohol have been reported. Instruct patients to reduce the amount of alcohol they consume until they know whether CHANTIX affects them. ( 5.3 ) • Accidental injury: Accidental injuries (e.g., traffic accidents) have been reported. Instruct patients to use caution driving or operating machinery until they know how CHANTIX may affect them. ( 5.4 ) • Cardiovascular events: A meta-analysis of 15 clinical trials, including a trial in patients with stable cardiovascular disease, demonstrated that while cardiovascular events were infrequent overall, some were reported more frequently in patients treated with CHANTIX. These events occurred primarily in patients with known cardiovascular disease. In both the clinical trial and meta-analysis, all-cause and cardiovascular mortality was lower in patients treated with CHANTIX. Instruct patients to notify their health care providers of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke. ( 5.5 and 6.1 ) • Angioedema and hypersensitivity reactions: Such reactions, including angioedema, infrequently life threatening, have been reported. Instruct patients to discontinue …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of CHANTIX use in pregnant women. In animal studies, CHANTIX caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. CHANTIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. These exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on AUC) at the maximum recommended human dose (MRHD) of 1 mg twice …

미국 제품명 CHANTIX, Tyrvaya

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 82,527건 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 오심nausea14,512
  2. 2 압박depression8,686
  3. 3 ABNORMAL DREAMS7,841
  4. 4 약효 없음drug ineffective6,007
  5. 5 불안anxiety5,979
  6. 6 불면증insomnia5,619
  7. 7 구토vomiting4,616
  8. 8 두통headache4,323
  9. 9 SUICIDAL IDEATION4,212
  10. 10 FEELING ABNORMAL4,023
  11. 11 권태감malaise4,011
  12. 12 NIGHTMARE3,357

미국 리콜 기록

FDA 리콜(회수) 기록 8건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2025.12.17 · 3등급(경미) · Dr. Reddy's Laboratories, Inc. Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
  • 2021.09.29 · 2등급 · Pfizer Inc. CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
  • 2021.09.29 · 2등급 · Pfizer Inc. CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
  • 2021.08.11 · 2등급 · Pfizer Inc. CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
  • 2021.08.11 · 2등급 · Pfizer Inc. CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

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.