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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: January 20, 2014.



Piroxicam is a commonly used nonsteroidal antiinflammatory drug (NSAID) that is available by prescription only and is used in therapy of chronic arthritis. Piroxicam can cause mild serum aminotransferase elevations and, in rare instances, leads to clinically apparent acute liver injury that can be severe and even fatal.


Piroxicam (pir ox' i kam) belongs to the oxicam family, which is a class of enolic acids structurally unrelated to other NSAIDs. Piroxicam, like other NSAIDs, acts through inhibition of tissue cyclooxygenases (Cox-1 and -2) leading to a decrease in synthesis of pro-inflammatory prostaglandins, which are potent mediators of pain and inflammation. Piroxicam has analgesic as well as antipyretic and antiinflammatory activities. Piroxicam was approved for use in the United States in 1982 and is still widely used, with several million prescriptions filled yearly. Current indications include rheumatoid arthritis and osteoarthritis. Piroxicam is available as capsules of 10 and 20 mg in several generic forms as well as under brand names such as Feldene, Novo-Pirocam and Nu-Pirox. The recommended dose is 10 to 20 mg orally once daily. Piroxicam is available by prescription only. Other oxicam NSAIDs include meloxicam, tenoxicam, and droxicam, the latter two being available in other countries, but not the United States. As with other NSAIDs, piroxicam is generally well tolerated, but side effects can include headache, dizziness, somnolence, dyspepsia, abdominal discomfort, diarrhea, peripheral edema and hypersensitivity reactions.


Elevated serum aminotransferase levels have been reported in 3% to 18% of patients taking piroxicam, but symptomatic liver disease with jaundice is rare (estimated at 1 to 5 cases per 100,000 prescriptions). The latency to onset of symptoms of clinically apparent liver injury due to piroxicam is variable from a few days to several months, but is generally within the first 1 to 6 weeks of treatment. The pattern of injury is predominantly cholestatic, although cases presenting with mixed or hepatocellular patterns have been reported (Case 1). Eosinophilia, rash and fever can occur, but are not always present and are usually not prominent. Autoantibodies are rarely found. The injury is usually self-limited and recovery occurs within 1 to 2 months. Rare cases of acute liver failure have been reported.

Mechanism of Injury

The mechanism of piroxicam induced liver injury is not known, but may be due to a toxic metabolic intermediate of piroxicam metabolism, which occurs largely in the liver. Cases with allergic manifestations (fever, rash, eosinophilia) may also have a component of hypersensitivity.

Outcome and Management

Severity of the liver injury from piroxicam ranges from asymptomatic elevations in serum aminotransferase levels to severe hepatitis with acute liver failure. Several instances of chronic vanishing bile duct syndrome have been attributed to other oxicam NSAIDs, but not specifically to piroxicam. In most instances, however, complete recovery is expected after stopping the drug and usually takes one to two months. Cross sensitivity to liver injury among the various NSAIDs has not been well studied or described. Due to the wide availability of alternative medications, rechallenge with piroxicam and other oxicam forms of NSAIDs (meloxicam, droxicam, tenoxicam) should be avoided.

Drug Class: Nonsteroidal Antiinflammatory Drugs, see also Meloxicam


Case 1. Acute cholestatic hepatitis arising 30 days after starting piroxicam therapy.

[Modified from: Caballeria E, Masso RM, Arago JV, Sanchis A. Piroxicam hepatotoxicity. Am J Gastroenterol 1990; 85: 898-9. PubMed Citation]

A 74 year old woman with chronic arthritis was treated for 30 days with piroxicam and presented 2 days later with pruritus and dark urine followed by jaundice. She had no history of liver disease or exposures to viral hepatitis and did not drink alcohol. She had hypertension and had been treated with atenolol and hydrochlorothiazide chronically. She had no fever or rash, but was jaundiced and had mild hepatic tenderness. Laboratory tests showed a total bilirubin of 6.5 mg/dL and prominent elevations in both ALT and alkaline phosphatase (Table) and eosinophilia. Tests for hepatitis A and B were negative. Ultrasound of the abdomen was normal. A liver biopsy showed intrahepatic cholestasis with minimal portal inflammation suggestive of drug induced liver disease. Her symptoms and jaundice cleared over the next month, and on follow up 3 months later, all liver tests were normal.

Key Points

Medication:Piroxicam (20 mg daily)
Pattern:Mixed→cholestatic (R=3.5→0.8)
Severity:2+ (jaundice but never hospitalized)
Latency:30 days to onset of symptoms
Recovery:Complete recovery between 1 and 3 months
Other medications:Atenolol and hydrochlorothiazide, chronically

Laboratory Values

Time After StartingTime After StoppingALT (U/L)Alk P (U/L)Bilirubin (mg/dL)Other
0Piroxicam started for arthritis
30 daysPiroxicam stopped
32 days06945756.5Itching, jaundice
34 days6 days2707366.2
40 days8 days35816883.8Liver Biopsy
54 days23 days15912401.5
60 days29 days506300.6
2 months1 month612910.6
4 months3 months361030.5
Normal Values<40<280<1.2


This patient had the onset of itching after a 30 day course of piroxicam. While the “R” value at the onset of injury (3.5) indicated a “mixed” hepatocellular-cholestatic pattern, the course was clearly cholestatic, with prominence of pruritus, further elevations in alkaline phosphatase (and rapid decreases in ALT yielding R values of <2), and a liver biopsy showing intrahepatic cholestasis with only mild inflammation and hepatocellular necrosis. Immunoallergic features were minimal: there was no rash or fever, but "discrete eosinophilia" was said to be present. Other causes of acute liver injury were effectively ruled out, and she recovered steadily once therapy was stopped. Application of the RUCAM causality system to this case gives a score of 8, which suggests that the likelihood that piroxicam is the cause of the injury is highly probable. As in this case, NSAID related hepatotoxicity may be more common in the elderly and among women.



Piroxicam – Generic, Feldene®


Nonsteroidal Antiinflammatory Drugs


Product labeling at DailyMed, National Library of Medicine, NIH


Piroxicam chemical structure


References updated: 20 January 2014

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    (51 year old woman developed jaundice within 4 days of starting tenoxicam [bilirubin 3.0 mg/dL, ALT 157 U/L, Alk P 365 U/L], resolving within 7 weeks of stopping).
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    (22 year old woman developed jaundice several months after starting piroxicam [bilirubin 7.8 mg/dL, ALT 387 U/L, Alk P 784 U/L], resolving within 8 weeks of stopping).
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    (33 year old man developed fever and jaundice 12 months after starting intermittent piroxicam [bilirubin 3.2 mg/dL, ALT 4828 U/L, Alk P normal], also developing renal insufficiency [creatinine 8.2 mg/dL]; recovery within 2 weeks).
  • Trak-Smayra V, Cazals-Hatem D, Asselah T, Duchatelle V, Degott C. Prolonged cholestasis and ductopenia associated with tenoxicam. J Hepatol 2003; 39: 125-8. [PubMed: 12821054]
    (36 year old man developed fever and jaundice 7 days after starting tenoxicam [an oxicam NSAID available in Europe], with bilirubin 30.9 mg/dL, ALT 1159 U/L, Alk P 2710 U/L and prolonged jaundice and biopsy showing cholangitis and intrahepatic cholestasis, very slow recovery marked by persistence of Alk P >1000 U/L, and repeat liver biopsies over 3 years showing progressive ductopenia).
  • Lacroix I, Lapeyre-Mestre M, Bagheri H, Pathak A, Montastruc JL; Club de Reflexion des cabinets de Groupe de Gastro-Enterologie(CREGG); General Practitioner Networks. Nonsteroidal anti-inflammatory drug-induced liver injury: a case-control study in primary care. Fundam Clin Pharmacol 2004; 18: 201-6. [PubMed: 15066135]
    (Case controlled study of patients presenting with suspected drug induced liver injury in a general practice context in Southern France found 88 cases which were matched with 178 controls; 22 cases vs 16 controls were exposed to NSAIDs; 5 diclofenac, 4 ibuprofen, 4 ketoprofen, 2 niflumic acid, 1 flurbiprofen and 1 meloxicam, the rest to salicylates which was just as commonly used in controls; piroxicam not mentioned).
  • de Abajo FJ, Montero D, Madurga M, García Rodríguez LA. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol 2004; 58: 71-80. [PMC free article: PMC1884531] [PubMed: 15206996]
    (Population based study of 1.6 million persons in UK found 128 suspected cases of drug induced liver disease, calculated odds ratios for liver injury to be 4.1 for diclofenac, but 0.4 for all other NSAIDs [2 cases only, both due to naproxen]).
  • Andrade RJ, Lucena MI, Fernández MC, et al.; Spanish Group for the Study of Drug-Induced Liver Disease. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 2005; 129: 512-21. [PubMed: 16083708]
    PubMed Citation (Reports to a Spanish network found 570 cases of drug induced liver disease with ibuprofen listed as 4th major cause; 18 cases in all: half mixed, half hepatocellular; eosinophilia in 2; acute liver failure in 2, one death and one liver transplant; piroxicam not mentioned).
  • Björnsson E, Jerlstad P, Bergqvist A, Olsson R. Fulminant drug-induced hepatic failure leading to death or liver transplantation in Sweden. Scand J Gastroenterol 2005; 40: 1095-101. [PubMed: 16165719]
    PubMed Citation (Summary of 25 years of adverse drug reaction reporting in Sweden identified 103 cases of drug induced acute liver failure; diclofenac and naproxen mentioned in top 20 causes; ibuprofen listed as associated with one case, but piroxicam not mentioned).
  • Lapeyre-Mestre M, de Castro AM, Bareille MP, Del Pozo JG, Requejo AA, Arias LM, et al. Non-steroidal anti-inflammatory drug-related hepatic damage in France and Spain: analysis from national spontaneous reporting systems. Fundam Clin Pharmacol 2006; 20:391-5. [PubMed: 16867024]
    (Analysis of reports of liver injury from NSAIDs from France and Spain from 1982-2001; relative risk definitely raised for droxicam, sulindac, nimesulide, and clometacin; minimally raised for naproxen, diclofenac, piroxicam and tenoxicam; 33 hepatic adverse events due to piroxicam reported from Spain and 378 from France).
  • 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 from 2004 to 2008, NSAIDs were implicated as a sole agent in 8 cases [4 diclofenac, 2 celecoxib, 1 meloxicam, 1 oxaprozin] and as one of several agents in 3 cases [1 diclofenac, 1 celecoxib, 1 ibuprofen], but none attibuted to piroxicam).
  • Bessone F. Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage? World J Gastroenterol 2010; 16: 5651-61. PubMed Citation. [PMC free article: PMC2997980] [PubMed: 21128314]
    (Review of estimated frequency of drug induced liver injury due to NSAIDs from large published epidemiological studies; mentions personal experience with two cases of piroxicam induced liver injury, one a 42 year old woman who developed acute liver failure 28 days after starting drug who eventually recovered, and a 42 year old man with severe and prolonged cholestasis which arose after 58 days of piroxicam use).
  • 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, of which 7 were due to NSAIDs, including 4 attributed to bromfenac, 2 to diclofenac and 1 to etodolac, but none to piroxicam).
  • Lapeyre-Mestre M, Grolleau S, Montastruc JL; Adsociation Française des Centres Régionaux de Pharmacovigilance (CRPV). Adverse drug reactions associated with the use of NSAIDs: a case/noncase analysis of spontaneous reports from the French pharmacovigilance database 2002-2006. Fundam Clin Pharmacol 2013; 27: 223-30. [PubMed: 21929527]
    (Analysis of spontaneous reporting of 42,389 adverse events to the French Pharmacovigilance database for 8 NSAIDs between 2002 and 2006; hepatic events per million daily doses was highest for nimesulide [0.15], compared to diclofenac [0.09], ketoprofen [0.09], naproxen [0.04], meloxicam [0.03], tenoxicam [0.03] and piroxicam [0.06]).


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