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The Drug-Induced Respiratory Disease Website and App

Frequency - Incidence

Incidence of respiratory adverse event(s) due to the specific drug as assessed by number of reported/published cases in the literature. Red digits in stars indicate: 0 = Very rare, questionable signal · 1 = < 10 cases · 2 = 10-50 cases · 3 = 50–100 cases · 4 = 100-200 cases · 5 = >200 cases

Evidence level/grade

Evidence level for respiratory adverse event(s) due to the specific drug as estimated using Hill’s (1965), Naranjo’s (1981), and Bégaud’s (1985) criteria applied to published cases. Blue digits in stars indicate: 0 = Questionable · 1 = Low · 2 = Moderate · 3 = Robust · 4 = Definite · 5 = Unquestionable, pathognomonic

XII.d

Myocarditis (can be fulminant)

Can be fatal (PMID 31020225, 31022941). May cause pulmonary edema (PMID 31020225). associate with skeletal muscle inflammation (myositis; PMID 30790071)

Publications

Pacaci B, Yildirim B, Tunc MA, Demirel A, Akagunduz F, Kocaaslan E, Guren AK, Demircan NC, Bayoglu IV

Immune checkpoint inhibitors and myocarditis-myositis-myasthenia gravis overlap: a FAERS pharmacovigilance study with time-to-onset characterization.

Frontiers in pharmacology. 2026;17:1825269

Gürdoğan M, Yalta K, Gürlertop Y, Karahan F, Bulburu İB, Koçyiğit B, Ustabaşıoğlu FE, Çiçin İ

Coexistence of Anti-PD1-Induced Immune Myocarditis and Complete Atrioventricular Block: A Case Report.

The American journal of cardiology. 2023;207:35-38

Mascolo A, Scavone C, Ferrajolo C, Rafaniello C, Danesi R, Del Re M, Russo A, Coscioni E, Rossi F, Alfano R, Capuano A

Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance.

Drug safety. 2021;44(9):957-971

Sobol I, Chen CL, Mahmood SS, Borczuk AC

Histopathologic Characterization of Myocarditis Associated With Immune Checkpoint Inhibitor Therapy.

Archives of pathology & laboratory medicine. 2020;144(11):1392-1396

Liu SY, Huang WC, Yeh HI, Ko CC, Shieh HR, Hung CL, Chen TY, Chen YJ

Sequential Blockade of PD-1 and PD-L1 Causes Fulminant Cardiotoxicity-From Case Report to Mouse Model Validation.

Cancers. 2019;11(4)

Salem JE, Manouchehri A, Moey M, Lebrun-Vignes B, Bastarache L, Pariente A, Gobert A, Spano JP, Balko JM, Bonaca MP, Roden DM, Johnson DB, Moslehi JJ

Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study.

The Lancet. Oncology. 2018;19(12):1579-1589

Mir H, Alhussein M, Alrashidi S, Alzayer H, Alshatti A, Valettas N, Mukherjee SD, Nair V, Leong DP

Cardiac Complications Associated With Checkpoint Inhibition: A Systematic Review of the Literature in an Important Emerging Area.

The Canadian journal of cardiology. 2018;34(8):1059-1068

Yamaguchi S, Morimoto R, Okumura T, Yamashita Y, Haga T, Kuwayama T, Yokoi T, Hiraiwa H, Kondo T, Sugiura Y, Watanabe N, Kano N, Kohno K, Fukaya K, Sawamura A, Yokota K, Ishii H, Nakaguro M, Akiyama M, Murohara T

Late-Onset Fulminant Myocarditis With Immune Checkpoint Inhibitor Nivolumab.

The Canadian journal of cardiology. 2018;34(6):812.e1-812.e3

Mahmood SS, Fradley MG, Cohen JV, Nohria A, Reynolds KL, Heinzerling LM, Sullivan RJ, Damrongwatanasuk R, Chen CL, Gupta D, Kirchberger MC, Awadalla M, Hassan MZO, Moslehi JJ, Shah SP, Ganatra S, Thavendiranathan P, Lawrence DP, Groarke JD, Neilan TG

Myocarditis in Patients Treated With Immune Checkpoint Inhibitors.

Journal of the American College of Cardiology. 2018;71(16):1755-1764

Ederhy S, Cautela J, Ancedy Y, Escudier M, Thuny F, Cohen A

Takotsubo-Like Syndrome in Cancer Patients Treated With Immune Checkpoint Inhibitors.

JACC. Cardiovascular imaging. 2018;11(8):1187-1190

Inayat F, Masab M, Gupta S, Ullah W

New drugs and new toxicities: pembrolizumab-induced myocarditis.

BMJ case reports. 2018;2018

Frigeri M, Meyer P, Banfi C, Giraud R, Hachulla AL, Spoerl D, Friedlaender A, Pugliesi-Rinaldi A, Dietrich PY

Immune Checkpoint Inhibitor-Associated Myocarditis: A New Challenge for Cardiologists.

The Canadian journal of cardiology. 2018;34(1):92.e1-92.e3

Norwood TG, Westbrook BC, Johnson DB, Litovsky SH, Terry NL, McKee SB, Gertler AS, Moslehi JJ, Conry RM

Smoldering myocarditis following immune checkpoint blockade.

Journal for immunotherapy of cancer. 2017;5(1):91

Cheng F, Loscalzo J

Autoimmune Cardiotoxicity of Cancer Immunotherapy.

Trends in immunology. 2017;38(2):77-78

Johnson DB, Balko JM, Compton ML, Chalkias S, Gorham J, Xu Y, Hicks M, Puzanov I, Alexander MR, Bloomer TL, Becker JR, Slosky DA, Phillips EJ, Pilkinton MA, Craig-Owens L, Kola N, Plautz G, Reshef DS, Deutsch JS, Deering RP, Olenchock BA, Lichtman AH, Rod

Fulminant Myocarditis with Combination Immune Checkpoint Blockade.

The New England journal of medicine. 2016;375(18):1749-1755