OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Sarecycline – Seysara®

DRUG CLASS

Antiinfective Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NO	MOLECULAR FORMULA	STRUCTURE
Sarecycline	1035979-44-2	C24-H29-N3-O8

ANNOTATED BIBLIOGRAPHY

References updated: 12 June 2026

Abbreviations used: ULN, upper limit of normal; iv, intravenous;

• Zimmerman HJ. Tetracyclines. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999. p. 599-602.

  (Expert review of tetracycline and liver injury published in 1999; the tetracyclines cause two forms of drug induced liver injury, microvesicular fat and liver failure occurring after 4-10 days with high doses of parenteral tetracyclines and an idiosyncratic liver injury that occurs with the oral agents, doxycycline causing a cholestatic and minocycline a hepatocellular injury which may be associated with autoimmune features).
• Moseley RH. Tetracyclines. Hepatotoxicity of antimicrobials and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, p. 468.

  (Expert review of tetracycline induced liver injury; mentions that the hepatotoxicity of intravenous tetracycline is of historic interest only as it is no longer given parenterally; both doxycycline and minocycline have been associated with idiosyncratic liver injury).
• MacDougall C. Protein synthesis inhibitors and miscellaneous antibacterial agents. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1049-65.

  (Textbook of pharmacology and therapeutics).
• https://www​.accessdata​.fda.gov/scripts/cder/daf/

  (FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA scientific review of the new drug application for safety and efficacy; mentions that pooled safety data indicated that serious adverse events were rare [<1%] and no more common with sarecycline [n=1820] than placebo [n=1113] treatment as were discontinuations for adverse events [1.3% vs 1.3%] and “there were no adverse effects with kidney or liver dysfunction” although 5 subjects discontinued sarecycline therapy because of liver enzyme elevations [one scored as “serious”], all of which were asymptomatic and resolved with stopping).
• Moore A, Green LJ, Bruce S, Sadick N, Tschen E, Werschler P, Cook-Bolden FE, et al. Once-daily oral sarecycline 1.5 mg/kg/day is effective for moderate to severe acne vulgaris: results from two identically designed, phase 3, randomized, double-blind clinical trials. J Drugs Dermatol 2018; 17: 987-96. [PubMed: 30235387]

  (Among 968 patients, ages 9 to 45 years, with facial acne treated with sarecycline or placebo for 12 weeks in 2 randomized controlled trials, inflammatory lesions improved more with sarecycline while adverse events included nausea [5%] and vomiting [2%] and more rarely dizziness and phototoxicity [<1%]; there were “no clinically meaningful differences … in clinical laboratory” measurements in either study).
• Leyden JJ, Sniukiene V, Berk DR, Kaoukhov A. Efficacy and safety of sarecycline, a novel, once-daily, narrow spectrum antibiotic for the treatment of moderate to severe facial acne vulgaris: results of a phase 2, dose-ranging study. J Drugs Dermatol 2018; 17: 333-8. [PubMed: 29537451]

  (Among 285 patients, ages 12 to 45 years, with severe facial acne vulgaris treated with 3 doses of sarecycline or placebo once daily for 12 weeks, inflammatory lesions were improved with higher doses of sarecycline vs placebo while adverse event rates were comparable and there were no serious adverse events; no mention of ALT elevations or hepatotoxicity).
• Deeks ED. Sarecycline: first global approval. Drugs. 2019; 79: 325-9. [PMC free article: PMC6505496] [PubMed: 30659422]

  (Review of the mechanism of action, pharmacology, clinical efficacy and safety of sarecycline from clinical trials on which its FDA approval was based; mentions that adverse events were uncommon but included nausea, vomiting, abdominal pain, sunburn, vulvovaginal candidiasis and mycotic infections; no mention of ALT elevations or hepatotoxicity).
• Pariser DM, Green LJ, Lain EL, Schmitz C, Chinigo AS, McNamee B, Berk DR. Safety and tolerability of sarecycline for the treatment of acne vulgaris: results from a phase III, multicenter, open-label study and a phase I phototoxicity study. J Clin Aesthet Dermatol. 2019;12:E53-E62. [PMC free article: PMC6937166] [PubMed: 32038757]

  (Among 483 patients with moderate-to-severe acne treated with sarecycline in an open label extension study for up to 40 weeks, adverse events arose in 39% of patients but only 4 were considered serious none of which were considered liver-related; ALT elevations arose in 3 patients [0.6%], all of which were transient and less than 3 times ULN).
• Del Rosso JQ, Draelos ZD, Effron C, Kircik LH. Oral sarecycline for treatment of papulopustular rosacea: results of a pilot study of effectiveness and safety. J Drugs Dermatol. 2021;20:426-431.. [PubMed: 33852248]

  (Among 102 adults with moderate-to-severe papulopustular rosacea treated with sarecycline or a multivitamin control for 12 weeks, inflammatory lesions improved more with sarecycline and there were no serious adverse events; no mention of ALT elevations or hepatotoxicity).
• Wei C, Liu Y, Jiang A, Wu B. A pharmacovigilance study of the association between tetracyclines and hepatotoxicity based on Food and Drug Administration adverse event reporting system data. Int J Clin Pharm. 2022;44:709-716. [] [PubMed: 35364753]

  (Analysis of tetracyclines in the FDA’s Adverse Event Reporting System [FAERS] over a 16 year period identified 1435 cases of liver injury, the most with minocycline [n=547], doxycycline [545], tigecycline [288], and tetracycline [41] with few attributed to omadacycline [4], oxytetracycline [3], eravacycline [2], sarecycline [2], and demeclocycline [1]; no clinical details provided).
• Bessone F, Hernandez N, Medina-Caliz I, García-Cortés M, Schinoni MI, Mendizabal M, Chiodi D, et al. Drug-induced liver injury in Latin America: 10-year experience of the Latin American DILI (LATINDILI) Network. Clin Gastroenterol Hepatol. 2025;23:89-102. [PubMed: 38992407]

  (Among 468 cases of idiosyncratic drug induced liver injury enrolled in a prospective Latin American database, 4 [0.9%] were attributed to minocycline, 1 [0.2%] each to doxycycline and tetracycline but none to eravacycline, omadacycline, sarecycline, or tigecycline).
• Drugs for acne. Med Lett Drugs Ther. 2024;66(1695):17-20.. [PubMed: 38294764]

  (Concise review of the mechanism of action, efficacy, safety, and costs of drugs for acne mentions that sarecycline is modestly effective and well tolerated; no mention of ALT elevations or hepatotoxicity).
• Zhang J, He L, Chen X, Tu Y, Kostov B, Cabedo J, Baykal T, et al. Efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris: randomized phase 3 clinical trial with open-label follow-up. Dermatol Ther (Heidelb). 2025;15:3285-3300. [PMC free article: PMC12549459] [PubMed: 40877730]

  (Among 391 Chinese patients with moderate-to-severe acne treated with sarecycline or placebo for 12 weeks followed by a 36-weeks open-label extension study, inflammatory lesions improved more with sarecycline while adverse event rates were similar [48% vs 50%] including increases in ALT [3% vs 2%] and there were no instances of clinically apparent liver injury).