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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Last Update: October 20, 2020.



The combination of ticarcillin and clavulanate provides an extended-spectrum penicillin with a beta-lactamase inhibitor and was previously used to treat serious bacterial infections due to susceptible organisms. Given parenterally, ticarcillin-clavulanate can cause mild transient aminotransferase elevations, and therapy has been linked to instances of acute cholestatic liver disease similar to that described commonly with amoxicillin-clavulanate (Augmentin).


The combination of ticarcillin, a fourth generation penicillin, and clavulanate combines the extended-spectrum of ticarcillin with beta-lactamase inhibitory activity of clavulanic acid. Neither ticarcillin nor ticarcillin-clavulanate are commercially available in the United States, the combination having been withdrawn from the market in 2015. This combination was indicated for serious infections of the lower respiratory tract, urinary tract, bones and joints and skin. The extended-spectrum of ticarcillin made it an appropriate agent in therapy of Pseudomonas aeruginosa. Ticarcillin also has extended activity against some Enterobacter and Proteus. Ticarcillin is poorly absorbed by mouth and requires parenteral administration. The combination of ticarcillin and clavulanate was approved for use in the United States initially in 1985 under the trade name of Timentin. The combination was provided as 3 grams of ticarcillin with 100 mg of clavulanate which was typically given intravenously every 4 to 6 hours for 5 to 14 days. Common side effects of ticarcillin included nausea, epigastric discomfort, diarrhea, headache, dizziness, rash and hypersensitivity reactions. Rare but potentially serious adverse events included anaphylaxis, hypersensitivity syndrome, renal dysfunction and Stevens Johnson syndrome.


Intravenous therapy with ticarcillin and clavulanate has been associated with elevations in serum aminotransferase levels in up to 10% of patients; however, these abnormalities were usually subclinical and self-limited. More important were rare instances of acute cholestatic liver injury arising several days to several weeks after initiation of ticarcillin-clavulanate. This hepatic injury resembled that caused by amoxicillin-clavulanate and was probably caused by the beta-lactamase inhibitor rather than the ticarcillin. However, too few cases were described in the literature to define the clinical characteristics of the idiosyncratic liver injury.

Likelihood score: D (possible rare cause of clinically apparent liver injury).

Mechanism of Injury

The cause of the liver injury associated with the combination of ticarcillin and clavulanate was probably hypersensitivity to the clavulanic acid. However, the possibility exists that some instances of hepatotoxicity following this combination were due to ticarcillin.

Outcome and Management

In the few cases of cholestatic liver injury following therapy with ticarcillin-clavulanate that have been described, resolution occurred rapidly in one patient whereas the second died of an underlying disease before recovery was complete. Cases of fatalities and chronic cholestasis have been described after amoxicillin-clavulanate therapy which is a much more commonly prescribed combination.

Drug Class: Antiinfective Agents, Penicillins (Fourth Generation)

Other Drugs in the Class: Piperacillin, Piperacillin-Tazobactam, Ticarcillin



Ticarcillin-Clavulanate – Generic, Timentin®


Antiinfective Agents


Product labeling at DailyMed, National Library of Medicine, NIH


Clavulanic Acid
86482-18-0 C15-H16-N2-O6-S2.
image 135061937 in the ncbi pubchem database


References updated: 20 October 2020

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  • Fontana RJ. Pathogenesis of idiosyncratic drug-induced liver injury and clinical perspectives. Gastroenterology. 2014;146:914–28. [PMC free article: PMC4031195] [PubMed: 24389305]
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    (Systematic review of literature of drug induced liver injury from Latin American countries published between 1996 and 2012 identified 176 cases, of which 37 [19%] were attributed to antimicrobials, including one to benzathine penicillin and 3 to amoxicillin-clavulanate, but none to 4th generation penicillins such as piperacillin or ticarcillin).
  • Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al. United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology. 2015;148:1340–52.e7. [PMC free article: PMC4446235] [PubMed: 25754159]
    (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, 323 [36%] were attributed to antibiotics of which 106 [12%] were due to penicillins including one to a 1st, three to a 2nd [all due to oxacillin], 97 to a 3rd [91 to amoxicillin-clavulanate, and 6 to amoxicillin alone], and five to a 4th generation penicillin [all 5 to piperacillin-tazobactam]).
  • Guéant JL, Romano A, Cornejo-Garcia JA, Oussalah A, Chery C, Blanca-López N, Guéant-Rodriguez RM, et al. HLA-DRA variants predict penicillin allergy in genome-wide fine-mapping genotyping. J Allergy Clin Immunol. 2015;135:253–9. [PubMed: 25224099]
    (In a genome wide association study of 387 patients with immediate allergic reactions to beta-lactam antibiotics, several class 2 HLA associations [HLA-DRA regions] were found for penicillin responses).
  • Björnsson ES. Drug-induced liver injury: an overview over the most critical compounds. Arch Toxicol. 2015;89:327–34. [PubMed: 25618544]
    (Review of the most common causes of drug induced liver injury in 3 recent surveys, all of which listed amoxicillin-clavulanate as the most frequent cause; none listed other penicillins).
  • Björnsson ES. Hepatotoxicity by drugs: the most common implicated agents. Int J Mol Sci. 2016;17:224. [PMC free article: PMC4783956] [PubMed: 26861310]
    (Review of the most common causes of drug induced liver injury based upon categorization from LiverTox, amoxicillin-clavulanate but no other penicillin was in the top category of causes [likelihood scores of A, with more than 100 cases published in the literature]).
  • Faulkner L, Gibson A, Sullivan A, Tailor A, Usui T, Alfirevic A, Pirmohamed M, et al. Detection of primary T cell responses to drugs and chemicals in HLA-typed volunteers: implications for the prediction of drug immunogenicity. Toxicol Sci. 2016;154:416–29. [PubMed: 27637899]
    (Demonstration of T cell priming to drugs linked with specific class I HLA-alleles).
  • Nicoletti P, Aithal GP, Bjornsson ES, Andrade RJ, Sawle A, Arrese M, Barnhart HX, et al. International Drug-Induced Liver Injury Consortium, Drug-Induced Liver Injury Network Investigators, and International Serious Adverse Events Consortium. Association of liver injury from specific drugs, or groups of drugs, with polymorphisms in HLA and other genes in a genome-wide association study. Gastroenterology. 2017;152:1078–89. [PMC free article: PMC5367948] [PubMed: 28043905]
    (A genome wide association study done on 862 Caucasian patients with drug induced liver injury demonstrated a strong link with HLA-A*33:01 in those with cholestatic liver injury, particularly in cases attributed to terbinafine, fenofibrate and ticlopidine).
  • Blumenthal KG, Youngster I, Rabideau DJ, Parker RA, Manning KS, Walensky RP, Nelson SB. Peripheral blood eosinophilia and hypersensitivity reactions among patients receiving outpatient parenteral antibiotics. J Allergy Clin Immunol. 2015;136:1288–94.e1. [PMC free article: PMC4640981] [PubMed: 25981739]
    (Among 824 patients who underwent outpatient parenteral antibiotic therapy for at least 2 weeks, 210 [25%] developed eosinophilia including 58 of 207 [28%] who received “penicillins” of whom 3 developed signs of “possible” DRESS syndrome; specific penicillins accounting for the cases were not provided).
  • Tailor A, Faulkner L, Naisbitt DJ, Park BK. The chemical, genetic and immunological basis of idiosyncratic drug-induced liver injury. Hum Exp Toxicol. 2015;34:1310–7. [PubMed: 26614821]
    (Review of mechanisms of idiosyncratic drug induced liver injury focusing upon chemically reactive drug metabolites and genetic associations, particularly those with HLA alleles that implicate the adaptive immune response).
  • Meng X, Earnshaw CJ, Tailor A, Jenkins RE, Waddington JC, Whitaker P, French NS, et al. Amoxicillin and clavulanate form chemically and immunologically distinct multiple haptenic structures in patients. Chem Res Toxicol. 2016;29:1762–72. [PubMed: 27603302]
    (Analysis of amoxicillin and clavulanate adducts produced in vitro and detected in vivo in patients with amoxicillin-clavulanate hepatotoxicity, the adducts were also present in culture median used to detect reactivity of specific T cell clones from patients).
  • Takeuchi Y, Shinozaki T, Kumamaru H, Hiramatsu T, Matsuyama Y. Analyzing intent-to-treat and per-protocol effects on safety outcomes using a medical information database: an application to the risk assessment of antibiotic-induced liver injury. Expert Opin Drug Saf. 2018;17:1071–9. [PubMed: 30252549]
    (Cohort matching of cases with vs without antibiotic therapy in a large electronic medical record database from the University of Tokyo Hospital from 2011 to 2015 with adjustments found rates of liver test abnormalities within 30 days of starting penicillins [25.2 per 1000] was higher than that of fluoroquinolones [11.4] and macrolide antibiotics [8.1] as well as controls [6.5 to 7.1]).
  • Cirulli ET, Nicoletti P, Abramson K, Andrade RJ, Bjornsson ES, Chalasani N, Fontana RJ, et al. Drug-Induced Liver Injury Network (DILIN) investigators. International DILI consortium (iDILIC). A missense variant in PTPN22 is a risk factor for drug-induced liver injury. Gastroenterology. 2019;156:1707–16.e2. [PMC free article: PMC6511989] [PubMed: 30664875]
    (Genome wide association studies on 2048 patients with drug induced liver injury and 12,439 controls identified a variant in PTPN22 which was highly associated with liver injury, allele frequency being 0.12 among cases and 0.08 among controls with highest association in Northern Europeans and in cases of amoxicillin clavulanate, PTPN22 being a cellular kinase involved in modulation of immune reactions).


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