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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: May 5, 2014.



Ceftriaxone is a third generation cephalosporin antibiotic which has been associated with development of biliary sludge and biliary colic when given parenterally and in high doses. Ceftriaxone is also associated with rare instances of immunoallergic, usually cholestatic hepatitis similar to the injury associated with other cephalosporins.


Ceftriaxone (sef" trye ax' one) is a third generation cephalosporin was was approved for use in the United States in 1984, and it continues to be widely used. Ceftriaxone is available in a parenteral formulation generically and under the brand name of Rocephin. It can be given either intravenously or intramuscularly and is indicated for therapy of moderate-to-severe bacterial infections caused by susceptible organisms. Typical dose regimens in adults are 1 to 2 grams given im or iv in one or two divided doses daily for 7 to 14 days. The parenteral cephalosporins are widely used in medicine for serious infections and can be safely given to patients with advanced liver disease, dose modifications being required mainly for renal insufficiency. Ceftriaxone is also approved for use in children.


Parenteral administration of ceftriaxone has been associated with development of biliary sludge in 3% to 46% of patients. The incidence may be higher in children than adults and is associated with higher doses and longer courses of treatment and possibly with fasting or dehydration. The syndrome is referred to as “pseudo-lithiasis” as the sludge and stones consist largely of ceftriaxone and they resolve spontaneously when the drug is stopped, indicating that surgery can be avoided. Most cases occur with minimal or no symptoms. Frank symptoms of cholecystitis are reported in up to 5% of patients who develop pseudo-lithiasis. Typically, serum enzymes and bilirubin levels remain normal even with biliary colic, but in rare instances there is cholestatic jaundice or gallstone pancreatitis that can be severe and require surgical intervention. Sludge and symptoms of gallbladder disease can arise within a few days of starting therapy, but typically resolve rapidly once ceftriaxone is stopped, although sludge and gallstones may be detectable by ultrasound for several months.

Ceftriaxone can also lead to an immunoallergic form of cholestatic hepatitis similar to what has been described with other cephalosporins. This reaction is idiosyncratic and is very rare. Symptoms of abdominal pain, nausea, pruritis and jaundice arise within 1 to 4 weeks of initiation of therapy and may worsen for 1 to 2 weeks after stopping the antibiotic. A cholestatic pattern of serum enzyme elevations and immunoallergic features of fever, rash and eosinophilia are common. The injury is usually mild and self-limited.

Mechanism of Injury

The mechanism of biliary sludge formation during ceftriaxone therapy appears to be the propensity of ceftriaxone to bind calcium and form insoluble crystals in bile in the gallbladder, resulting in biliary sludge or frank stones. This complication is not idiosyncratic, being demonstrable in animal models. In a similar manner, calcium salts of ceftriaxone can precipitate in urine and lead to sludge in ureters or bladder that are capable of causing urinary obstruction or symptomatic kidney and bladder stones. The rare, idiosyncratic acute cholestatic liver injury linked to ceftriaxone is probably due to hypersensitivity.

Outcome and Management

In most case reports, recovery has been rapid within 1 to 2 weeks, but some patients have required cholecystectomy during the acute illness and stones or sludge may persist for up to several months. The immunoallergic form of cholestatic hepatitis generally resolves rapidly and has not been associated with acute liver failure or chronic injury.

Drug Class: Antiinfective Agents, Cephalosporins


Case 1. Biliary sludge and cholestatic hepatitis during intravenous administration of ceftriaxone.

[Modified from: Zinberg J, Chernaik R, Coman E, Rosenblatt R, Brandt LJ. Reversible symptomatic biliary obstruction associated with ceftriaxone pseudolithiasis. Am J Gastro 1991; 86: 1251-4. PubMed Citation].

A 73 year old woman with rheumatoid arthritis developed nausea and right upper quadrant pain on the twelfth day of therapy with iv ceftriaxone for Klebsiella sepsis. A DISIDA scan demonstrated nonvisualization of the gallbladder and no excretion after 4 hours, suggesting common bile duct obstruction. Serum enzymes and amylase levels, which had been normal on admission, were increased. Abdominal ultrasound showed multiple small calculi in the gallbladder, but no biliary dilatation. Ultrasound done early during the hospitalization (for evaluation of renal disease) had shown a normal gallbladder without stones. Ceftriaxone was stopped a few days later and her abdominal pain and nausea improved promptly. Four days later, amylase and ALT levels were normal. Four weeks later, ultrasound demonstrated disappearance of the gallstones and alkaline phosphatase levels were normal.

Key Points

Medication:Ceftriaxone, 1.0 gram iv every 12 hours for 14 days
Pattern:Cholestatic (R=1.7)
Severity:1+ (no jaundice)
Latency:Twelve days
Recovery:Complete in 4 weeks
Other medications:Piroxicam, ranitidine, furosemide, thyroxine, vitamin D, calcium

Laboratory Values

Time After StartingTime After StoppingALT (U/L)Alk P (U/L)Bilirubin (mg/dL)Other
Pre511030.2Admission for GI bleeding
0Ceftriaxone started (day 7 of hospitalization)
12 daysAbdominal pain and nausea: gallbladder sludge
13 days921830.4Amylase 513
14 days252299NormalCeftriaxone stopped
18 days4 days52245Ultrasound: single gallstone
6 weeks4 weeksNormalNormalNormalUltrasound: no gallstones
Normal ValuesNot given<1.2


Only 5% to 10% of patients who develop biliary sludge (pseudolithiasis) during ceftriaxone therapy develop symptoms of biliary colic and, even with symptoms, patients rarely develop elevations of serum enzymes or bilirubin levels. The case described above developed what appeared to be a gallstone pancreatitis and partial biliary obstruction leading to mild elevations in serum aminotransferase and alkaline phosphatase levels, but without jaundice. The development of ceftriaxone biliary stones during therapy and dissolution afterwards was nicely documented in this case report. The biliary symptoms resolved with a day or two and the stones within 4 weeks of stopping therapy.



Ceftriaxone – Generic, Rocephin®


Antiinfective Agents


Product labeling at DailyMed, National Library of Medicine, NIH


Ceftriaxone Sodium74578-69-1C18-H18-N8-O7-S3.2Na
Ceftriaxone sodium chemical structure


References updated: 05 May 2014

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  • Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924-34. [PMC free article: PMC3654244] [PubMed: 18955056]
    (Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008, one case was attributed to ceftriaxone alone [85 year old man developed cholestatic hepatitis 3 weeks after a four day course of intravenous ceftriaxone]).
  • Peker E, Cagan E, Dogan M. Ceftriaxone-induced toxic hepatitis. World J Gastroenterol 2009; 15: 2669-71. [PMC free article: PMC2691501] [PubMed: 19496200]
    (12 year old boy developed fatigue after 3 days of ceftriaxone therapy followed by jaundice [bilirubin 4.2 mg/dL, ALT 871 U/L, Alk P 143 U/L, 8% eosinophils], resolving within 10 weeks of stopping).
  • Ferrajolo C, Capuano A, Verhamme KM, Schuemie M, Rossi F, Stricker BH, Sturkenboom MC. Drug-induced hepatic injury in children: a case/non-case study of suspected adverse drug reactions in VigiBase. Br J Clin Pharmacol 2010; 70: 721-8. [PMC free article: PMC2997312] [PubMed: 21039766]
    (Worldwide pharmacovigilance database contained 9036 hepatic adverse drug reactions in children, 104 of which were attributed to ceftriaxone, ranking 10th in frequency and being the only cephalosporin listed).
  • Reuben A, Koch DG, Lee WM; Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 2010; 52: 2065-76. [PMC free article: PMC3992250] [PubMed: 20949552]
    (Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury, one of which was attributed to cefepime, but none to ceftriaxone or other cephalosporins).
  • Kaur I, Singh J. Cholestatic hepatitis with intravenous ceftriaxone. Indian J Pharmacol 2011; 43: 474-5. doi: 21845011 . [PMC free article: PMC3153719] [PubMed: 21845011]
    (24 year old woman developed dark urine 24 hours after starting ceftriaxone and piroxicam and 3 days later was jaundiced [bilirubin 6.5 mg/dL, ALT 164 U/L, Alk P 580 U/L], resolving within 3 weeks of stopping both drugs).
  • Choi YY, Jung YH, Choi SM, Lee CS, Kim D, Hur KY. Gallbladder pseudolithiasis caused by ceftriaxone in young adult. J Korean Surg Soc 2011; 81:423-6. [PMC free article: PMC3243861] [PubMed: 22200045]
    (Two men, ages 21 and 22 years, developed gallstones found by CT scan 5 and 17 days after starting ceftriaxone without symptoms or laboratory abnormalities, resolving within 1 month of stopping).
  • Hanata N, Imamura T, Koyama R, Koizumi Y, Tamura T, Ito J, Takeuch K. [Case report; a case of biliary pseudolithiasis associated with ceftriaxone]. Nihon Naika Gakkai Zasshi 2012; 101: 2955-7. Japanese. [PubMed: 23214106]
  • Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S. Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology 2013; 114: 1419-25. [PubMed: 23419359]
    (In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period, of which 2 were attributed to cephalosporins, one with jaundice to cephalexin and one with enzyme elevations only to ceftazidime).
  • Rodríguez Rangel DA, Pinilla Orejarena AP, Bustacara Diaz M, Henao García L, López Cadena A, Montoya Camargo R, Moreno LA. [Gallstones in association with the use of ceftriaxone in children.]. An Pediatr (Barc) 2013; 80: 77-80. Spanish. [PubMed: 23759541]
    (Prospective study in 73 children receiving ceftriaxone, identified sludge or gallstones [4-14 mm in diameter] by ultrasound in 31 [43%], of whom 7 had symptoms, all resolving within 2 months of stopping, but one requiring surgery).
  • Zheng FY, Xing Y, Lu S, Liu DM. [Ceftriaxone-associated biliary pseudolithiasis in a child with nephrotic syndrome]. Zhongguo Dang Dai Er Ke Za Zhi 2013; 15: 696-7. Chinese. [PubMed: 23965889]
  • Tomoda T, Ueki T, Saito S, Tatsukawa M, Nawa T, Hamamoto H, Endo H, et al. [A case of ceftriaxone-associated pseudolithiasis in an adult patient that disappeared after the discontinuation of ceftriaxone]. Nihon Shokakibyo Gakkai Zasshi 2013; 110: 1481-6. Japanese. [PubMed: 23912008]
    (47 year old woman found to have developed biliary stones and sludge on CT scan after 8 days of intravenous ceftriaxone, which disappeared within 6 days).
  • von Martels JZ, Van de Meeberg EK, Holman M, Ligtenberg JJ, Ter Maaten JC. Pseudolithiasis after recent use of ceftriaxone: an unexpected diagnosis in a child with abdominal pain. Am J Emerg Med 2013; 31: 1294. e5-6. [PubMed: 23809091]
    (14 year old boy treated for Lyme disease with a 2 week course of iv ceftriaxone presented 4 days later with abdominal pain and biliary stones by ultrasound and ERCP [bilirubin 4.2 mg/dL, ALT 187 U/L, Alk P 398, GGT 291 U/L], resolving with conservative management within a few days and no stones found on follow-up ultrasound 4 weeks later).
  • Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America. An analysis of published reports. Ann Hepatol 2014; 13: 231-9. [PubMed: 24552865]
    (Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, but none were attributed to ceftriaxone or a cephalosporin).
  • Alemayehu H, Desai AA, Thomas P, Sharp SW, St Peter SD. Ceftriaxone-induced pseudolithiasis in children treated for perforated appendicitis. Pediatr Surg Int 2014; 30: 323-6. [PubMed: 24464035]
    (Among 71 children treated with iv ceftriaxone for perforated appendicitis, 10 [14%] developed gallbladder stones or sludge, one of whom developed symptoms and underwent cholecystectomy).


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