OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Praziquantel – Biltricide®

DRUG CLASS

Anthelmintic Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NUMBER	MOLECULAR FORMULA	STRUCTURE
Praziquantel	55268-74-1	C19-H24-N2-O2

ANNOTATED BIBLIOGRAPHY

References updated: 20 July 2020

• Zimmerman HJ. Antihelminthics. Hepatic injury from antimicrobial agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 626-8.

  (Expert review of hepatotoxicity of anthelmintics written in 1999; praziquantel has been reported to cause serum aminotransferase elevations).
• Keiser J, McCarthy J, Hotez P. Chemotherapy of helminth infections. 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. 1001-9.

  (Textbook of pharmacology and therapeutics).
• Chen MG, Fu S, Hua XJ, Wu HM. A retrospective survey on side effects of praziquantel among 25,693 cases of schistosomiasis Japonica. Southeast Asian J Trop Med Public Health. 1983;14:495–500. [PubMed: 6673126]

  (Retrospective survey of side effects after a 1-2 day course of praziquantel for Schistosomiasis in 25,693 patients from China; 2 patients developed jaundice 1-5 days after treatment, both resolving within 2 weeks; 2 other patients with advanced liver disease had acute decompensation shortly after therapy; no details given).
• Matthaiou DK, Panos G, Adamidi ES, Falagas ME. Albendazole versus praziquantel in the treatment of neurocysticercosis: a meta-analysis of comparative trials. PLoS Negl Trop Dis. 2008;2:e194. [PMC free article: PMC2265431] [PubMed: 18335068]

  (Systematic review of efficacy of albendazole versus praziquantel; mentions that there were no differences in rates of adverse events, but no details given).
• Yangco BG, De Lerma C, Lyman GH, Price DL. Clinical study evaluating efficacy of praziquantel in clonorchiasis. Antimicrob Agents Chemother. 1987;31:135–8. [PMC free article: PMC174677] [PubMed: 3551827]

  (Controlled trial of praziquantel vs placebo in 42 patients with clonorchiasis treated for one day twice 30 days apart; side effects included nausea, vomiting and dizziness, but there were no increases in ALT levels).
• Seo BS, Lee SH, Chai JY, Hong ST. Praziquantel(Distocide®) In treatment of Clonorchis Sinensis infection. Kisaengchunghak Chapchi. 1983;21:241–5. [PubMed: 12902655]

  (Among 55 Korean patients with liver flukes treated with praziquantel [75 mg/kg over one day], none developed clinical liver injury and average serum AST levels did not change).
• Ross AG, Sleigh AC, Li Y, Davis GM, Williams GM, Jiang Z, Feng Z, McManus DP. Schistosomiasis in the People's Republic of China: prospects and challenges for the 21st century. Clin Microbiol Rev. 2001;14:270–95. [PMC free article: PMC88974] [PubMed: 11292639]

  (Review of the burden of schistosomiasis japonica infections in China and approaches to treatment and prevention including use of praziquantel in the general population).
• Shen C, Choi MH, Bae YM, Yu G, Wang S, Hong ST. A case of anaphylactic reaction to praziquantel treatment. Am J Trop Med Hyg. 2007;76:603–5. [PubMed: 17360893]

  (35 year old man with clonorchiasis developed dizziness, urticaria, dyspnea, palpitations and nausea after a single dose of praziquantel with abnormal aminotransferase levels [ALT 81 U/L, AST 132 U/L], symptoms resolving within a few days).
• 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 collected in the US between 2003 and 2008, none were attributed to an anthelmintic agent).
• Devarbhavi H, Dierkhising R, Kremers WK, Sandeep MS, Karanth D, Adarsh CK. Single-center experience with drug-induced liver injury from India: causes, outcome, prognosis, and predictors of mortality. Am J Gastroenterol. 2010;105:2396–404. [PubMed: 20648003]

  (313 cases of drug induced liver injury were seen over a 12 year period at a large hospital in Bangalore, India; none were attributed to anthelmintic agents).
• 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, there were no anthelmintic agents listed among the top 40 implicated medications).
• Drugs for parasitic infections. Treat Guidel Med Lett. 2013;11 Suppl:e1–31.

  (Brief description of drugs for parasitic infections in adults and children as well as a table of their major side effects; praziquantel is the drug of choice for schistosomiasis, liver flukes [Clonorchis sinensis and others], and intestinal tapeworm; side effects can include abdominal pain, diarrhea, fatigue, nausea, drowsiness, fever and rash).
• Wu W, Huang Y. Application of praziquantel in schistosomiasis japonica control strategies in China. Parasitol Res. 2013;112:909–15. [PubMed: 23358736]

  (Summary of results of approaches to decreasing schistosomiasis japonica infection in China with discussion of success and safety of praziquantel prophylaxis in the general population; no mention of hepatotoxicity).
• 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, only one of which was attributed to an anthelmintic, mebendazole; none were attributed to praziquantel).
• 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, 409 [46%] were attributed to antimicrobial agents, but none to anthelmintics or to praziquantel).
• Qian MB, Utzinger J, Keiser J, Zhou XN. Clonorchiasis. Lancet. 2016;387(10020):800–10. [PubMed: 26299184]

  (Review of the life cycle, epidemiology, clinical course and complications of Clonorchis sinensis infection mentions that praziquantel is the treatment of choice and is used in mass prevention and is highly effective with only transient and mild adverse events; no mention of liver test abnormalities).
• Gassiep I, Clark PJ, McManus DP, Looke DL. Hepatobiliary and pancreatic: Acute hepatitis in the setting of chronic Schistosoma mansoni infection and post-praziquantel therapy. J Gastroenterol Hepatol. 2016;31:910. [PubMed: 26598933]

  (19 year old man with hepatomegaly [bilirubin 3.0 mg/dL, ALT 1220 U/L, Alk P 331 U/L] and stool tests showing S. mansoni had delayed but ultimately full resolution of liver test abnormalities after praziquantel therapy).
• Gong Z, Xu Z, Lei C, Wan C. Hepatic paragonimiasis in a 15-month-old girl: a case report. BMC Pediatr. 2017;17:190. [PMC free article: PMC5688620] [PubMed: 29141594]

  (15 month old female with fever and hepatomegaly and multiple low density hepatic lesions had hepatic paragonimiasis on liver biopsy and resolution after 3 days of praziquantel therapy).
• Sayasone S, Keiser J, Meister I, Vonghachack Y, Xayavong S, Senggnam K, Phongluxa K, et al. Efficacy and safety of tribendimidine versus praziquantel against Opisthorchis viverrini in Laos: an open-label, randomised, non-inferiority, phase 2 trial. Lancet Infect Dis. 2018;18:155–61. [PubMed: 29153938]

  (Among 607 children with O. viverrini liver fluke infection treated with tribendimidine or praziquantel, cure rates were 97% vs 95% while adverse events rose in the days following treatment in 33% vs 70%, usual symptoms with praziquantel being headache, nausea, dizziness, fatigue and abdominal cramps; no mention of ALT elevations or hepatotoxicity).
• Hong ST. Albendazole and praziquantel: review and safety monitoring in Korea. Infect Chemother. 2018;50:1–10. [PMC free article: PMC5895825] [PubMed: 29637747]

  (Korean registry of adverse event reports made between 2006 and 2015 included 108 praziquantel events which were usually mild and transient gastrointestinal and neurologic symptoms, with one report of abnormal liver tests; no details provided).
• McManus DP, Dunne DW, Sacko M, Utzinger J, Vennervald BJ, Zhou XN. Schistosomiasis. Nat Rev Dis Primers. 2018;4:13. [PubMed: 30093684]

  (Extensive review of the pathogenesis, epidemiology, clinical course, complications and management of schistosomiasis mentions that praziquantel is the most effective and widely used therapy, is active against all Schistosoma species, but only against adult worms for which reason it does not prevent reinfection and can give rise to drug resistance; praziquantel has transient, mild adverse events most of which are attributable to worm release rather than direct effects of the drug).
• Shindo T, Masuda Y, Imai Y, Nagano T, Nishioka H. Case Report: Acute generalized exanthematous pustulosis caused by praziquantel. Am J Trop Med Hyg. 2019;100:700–2. [PMC free article: PMC6402890] [PubMed: 30675838]

  (30 year old man developed fever and rash the day after a single dose of praziquantel with abnormal liver tests [bilirubin 1.5 mg/dL, ALT 841 U/L, Alk P 468 U/L], symptoms resolving over the next week with normal tests 16 days later).
• Darko SN, Hanson H, Twumasi-Ankrah S, Baffour-Awuah S, Adjei-Kusi P, Yar D, Owusu-Dabo E. Three monthly doses of 60 mg/kg praziquantel for Schistosoma haematobium infection is a safe and effective treatment regimen. BMC Infect Dis. 2020;20:323. [PMC free article: PMC7204294] [PubMed: 32375658]

  (Therapy of 28 patients with S. haematobium infection with 3 monthly doses of praziquantel was highly effective and serum ALT, AST and GGT levels during the 3 months were no different than levels in 53 control subjects followed concurrently).