Oxaprozin – LiverTox – NCBI Bookshelf

Last Update: March 20, 2020.

OVERVIEW

Introduction

Oxaprozin is a long acting nonsteroidal antiinflammatory drug (NSAID) available by prescription only which is used for therapy of chronic arthritis. Oxaprozin has been linked to rare instances of idiosyncratic drug induced liver disease.

Background

Oxaprozin (ox” a proe’ zin) belongs to the propionic acid derivative class of NSAIDs similar to naproxen and ibuprofen. Like other NSAIDs, oxaprozin is a potent cyclo-oxygenase (Cox-1 and -2) inhibitor which leads to decrease in synthesis of proinflammatory prostaglandins, which are potent mediators of pain and inflammatory pathways. Oxaprozin has analgesic as well as antipyretic and antiinflammatory activities. Because of its long half-life, oxaprozin can be given once daily. Oxaprozin was approved in the United States in 1992 and is still widely used. Oxaprozin is indicated for the treatment of chronic arthritis due to osteoarthritis, rheumatoid arthritis and juvenile rheumatoid arthritis. Oxaprozin is available in capsules of 600 mg in several generic forms and under the brand name Daypro. The recommended dose in adults is 600 to 1200 mg once daily. As with other NSAIDs, oxaprozin is generally well tolerated, but side effects can include headache, dizziness, somnolence, dyspepsia, nausea, abdominal discomfort, heartburn, peripheral edema and hypersensitivity reactions. Rare but serious adverse events from NSAIDs include gastrointestinal ulceration and bleeding, increased risk for cardiovascular disease, renal dysfunction, exacerbation of asthma and hypersensitivity reactions including anaphylaxis, exfoliative dermatitis and Stevens Johnson syndrome.

Hepatotoxicity

Prospective studies show that up to 15% of patients taking oxaprozin chronically experience at least transient serum aminotransferase elevations. These usually resolve even with drug continuation. Marked aminotransferase elevations (>3 fold elevated) occur in approximately 1% of patients.

Clinically apparent liver injury with jaundice from oxaprozin is rare (~1 per 100,000 person-years of use) and it is rarely listed in large surveys of cases of drug induced liver injury. The usual clinical presentation is an acute hepatitis-like picture arising 2 to 8 weeks after starting the medication. The pattern of injury is typically hepatocellular, but mixed hepatocellular-cholestatic cases have been described. Symptoms may include allergic manifestations such as fever, rash, arthralgias and facial edema. Autoantibody formation is rare. Liver biopsy findings are hepatocellular necrosis with prominent periportal and lobular eosinophilic infiltration suggestive of drug induced acute hepatitis. Recovery may be delayed for several days, but is usually complete within one to two months. At least one case of acute liver failure attributed to oxaprozin has been published.

Likelihood score: C (probable rare cause of clinically apparent liver injury).

Mechanism of Injury

The mechanism of oxaprozin hepatotoxicity is not known, but the allergic phenomena that accompany clinically apparent injury suggests an immunoallergic cause. Rechallenge leads to rapid recurrence and should be avoided.

Outcome and Management

Severity ranges from asymptomatic elevations in serum aminotransferase levels, to symptomatic hepatitis with or without jaundice (Case 1), to acute liver failure. Rapid improvement in symptoms and complete recovery are expected after discontinuing the medication. Complete recovery may take several months. Cross sensitivity to liver injury among the various NSAIDs has not been well studied or described, but in several case reports patients with oxaprozin associated hepatotoxicity had previously tolerated therapy with other propionic acid derivative NSAIDs (such as ibuprofen, naproxen or ketoprofen). Nevertheless, patients with oxaprozin induced clinically apparent liver injury should be carefully monitored during the first few weeks of starting a different NSAID.

Drug Class: Nonsteroidal Antiinflammatory Drugs

CASE REPORT

Case 1. Acute immunoallergic hepatitis due to oxaprozin.(1)

A 45 year old woman was given oxaprozin (1200 mg once daily) for painful “tennis elbow” (epicondylitis). She had a past medical history of asthma and an allergic reaction to sulfonamides. After 3 weeks of taking oxaprozin, she developed dark urine, anorexia, high fevers and right upper quadrant pain. All of her medications were stopped, but in the next few days she developed worsening symptoms, itching and a maculopapular rash. Physical examination revealed tenderness over the liver and spleen. Tests for viral hepatitis and autoimmune markers were negative. An abdominal ultrasound showed enlargement of the liver and spleen and gallstones, but no dilatation of bile ducts. CT scan was normal. A liver biopsy showed severe lobular hepatitis with mixed inflammatory response and numerous eosinophils. One month after stopping oxaprozin, her symptoms had resolved and ALT and alkaline phosphatase levels had improved. Two months after stopping, all liver tests were normal.

Key Points

Laboratory Values

CHEMICAL FORMULA AND STRUCTURE

CITED REFERENCES

1.

Schmeltzer PA, Kosinski AS, Kleiner DE, Hoofnagle JH, Stolz A, Fontana RJ, Russo MW., Drug-Induced Liver Injury Network (DILIN). Liver injury from nonsteroidal anti-inflammatory drugs in the United States. Liver Int. 2016;36:603–9. [PMC free article: PMC5035108] [PubMed: 26601797]

ANNOTATED BIBLIOGRAPHY

References updated: 20 March 2020

Abbreviations: NSAIDs, nonsteroidal antiinflammatory drugs.

• Zimmerman HJ. Drugs used to treat rheumatic and musculospastic disease. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 517-53.

  (Expert review of hepatotoxicity published in 1999; overt hepatitis due to oxaprozin is rare, but there have been several unreported cases of hepatocellular jaundice during oxaprozin use).

• Lewis JH, Stine JG. Nonsteroidal anti-inflammatory drugs and leukotriene receptor antagonists: pathology and clinical presentation of hepatotoxicity. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd Edition. Amsterdam: Elsevier, 2013. pp. 370-402.

  (Review of hepatotoxicity of NSAIDs mentions that overt hepatitis due to oxaprozin is rare, but two case reports have been published).

• Grossner T, Smyth EM, Fitzgerald GA. Pharmacotherapy of inflammation, fever, pain, and gout. In, Brunton LL, Hilal-Dandan R, Knollman BC. Goodman & Gilman’s The pharmacological basis of therapeutics, 13th ed. New York: McGraw-Hill, 2018. pp. 685-709.

  (Textbook of pharmacology and therapeutics).

• Janssen FW, Jusko WJ, Chiang ST, Kirkman SK, Southgate PJ, Coleman AJ, et al. Metabolism and kinetics of oxaprozin in normal subjects. Clin Pharmacol Ther. 1980;27:352–62. [PubMed: 7357792]

  (Extensive review of the pharmacokinetics of oxaprozin showing that it is well absorbed orally, metabolized by the liver, excreted in the urine and has a long serum half-life, perhaps because it is highly protein bound; long half-life allows for once daily dosing).

• Zimmerman HJ. Hepatic effects of oxaprozin. Semin Arthritis Rheum. 1986;15 Suppl 2:35–9.

  (Classic analysis of hepatic injury in the large clinical studies of oxaprozin, reporting some degree of AST elevation in 15.4% of 1135 subjects, usually transient, mild and asymptomatic; elevations >3x ULN occurred in 12 [1.1%] patients with values 95-433 U/L, one subject developed symptoms, but no jaundice).

• Freeland GR, Northington RS, Hedrich DA, Walker BR. Hepatic safety of two analgesics used over the counter: ibuprofen and aspirin. Clin Pharmacol Ther. 1988;43:473–9. [PubMed: 3365912]

  (Prospective study of safety of ibuprofen, aspirin and oxaprozin in 1468 patients; AST elevations occurred in 5-15% of those on oxaprozin, 6-16% aspirin and 3% ibuprofen, but were above 3 times ULN in only 0.4-1% on oxaprozin, 5% aspirin and none ibuprofen).

• Miller LG. Oxaprozin: a once-daily nonsteroidal anti-inflammatory drug. Clin Pharm. 1992;11:591–603. [PubMed: 1617910]

  (Thorough summary of chemistry, pharmacology, pharmacokinetics, clinical efficacy and safety of oxaprozin based upon prelicensure studies; no new information on hepatotoxicity).

• Purdum PP 3rd, Shelden SL, Boyd JW, Shiffman ML. Oxaprozin-induced fulminant hepatitis. Ann Pharmacother. 1994;28:1159–61. [PubMed: 7841569]

  (56 year old woman developed jaundice 6 weeks after switching from ketoprofen to oxaprozin [bilirubin 32.1 mg/dL, ALT 4325 U/L, Alk P 335 U/L], with progressive hepatic failure and death).

• Weaver A, Rubin B, Caldwell J, McMahon FG, Lee D, Makarowski W, et al. Comparison of the efficacy and safety of oxaprozin and nabumetone in the treatment of patients with osteoarthritis of the knee. Clin Ther. 1995;17:735–45. [PubMed: 8565037]

  (Review of safety of oxaprozin without new information on hepatotoxicity).

• Manoukian AV, Carson JL. Nonsteroidal anti-inflammatory drug-induced hepatic disorders. Incidence and prevention. Drug Saf. 1996;15:64–71. [PubMed: 8862964]

  (Review of hepatotoxicity of NSAIDs, recapitulation of oxaprozin data presented by Zimmerman [1986]).

• Kethu SR, Rukkannagari S, Lansford CL. Oxaprozin-induced symptomatic hepatotoxicity. Ann Pharmacother. 1999;33:942–4. [PubMed: 10492496]

  (41 year old man developed jaundice 6 weeks after starting oxaprozin for shoulder pain [bilirubin 3.7 mg/dL, ALT 1950 U/L, Alk P 357 U/L], resolving within 8 weeks of stopping).

• Lapeyre-Mestre M, de Castro AM, Bareille MP, Garcia del Pozo J, Requejo AA, Arias LM, Montastruc J-L, 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]

  (Survey of NSAID adverse drug reaction reports in Spain and France between 1982 and 2001; oxaprozin is not listed among 24 NSAIDs analyzed).

• 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 and 1 oxaprozin] and as one of several agents in 3 cases [1 diclofenac, 1 celecoxib, 1 ibuprofen]: Case 1).

• 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 and 7 to NSAIDs, including 4 to bromfenac, 2 diclofenac and 1 etodolac, but none to oxaprozin, ibuprofen or naproxen).

• Bessone F. Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage? World J Gastroenterol. 2010;16:5651–61. [PMC free article: PMC2997980] [PubMed: 21128314]

  (Review of estimated frequency of drug induced liver injury due to NSAIDs from large published epidemiological studies; oxaprozin not discussed).

• Suzuki A, Andrade RJ, Björnsson E, Lucena MI, Lee WM, Yuen NA, Hunt CM, et al. Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work. Drug Saf. 2010;33:503–22. [PubMed: 20486732]

  (The combination of several large data sources identified 385 different drugs to be linked to liver injury and 107 to acute liver failure, the most commonly implicated NSAIDs being diclofenac, ibuprofen, naproxen, nimesulide, piroxicam, and sulindac; oxaprozin not mentioned).

• Zhou Y, Yang L, Liao Z, He X, Zhou Y, Guo H. Epidemiology of drug-induced liver injury in China: a systematic analysis of the Chinese literature including 21 789 patients. Eur J Gastroenterol Hepatol. 2013;25:825–9. [PubMed: 23510965]

  (Search of 3 electronic databases of the Chinese medical literature from 1994-2011 identified 279 reports on a total of 24,111 patients with drug induced liver injury, the most commonly implicated being antituberculosis agents [31%], HDS products [19%], antibiotics [10%] and NSAIDs [7.6%], and the most frequent individual NSAIDs being acetaminophen, ibuprofen, indometacin, aspirin and phenylbutazone).

• 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;144:1419–25. [PubMed: 23419359]

  (Prospective analysis of all cases of drug induced liver injury in Iceland between 2010-11 identified 97 cases [19 per 100,000 inhabitants], 6 of which were attributed to diclofenac; no other NSAID mentioned).

• 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, the most common class of implicated agents being NSAIDs [n=62, 32%], and specific agents were nimesulide [n=53], piroxicam [5], diclofenac [2], gold salts [1], and naproxen [1]).

• 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, 28 were attributed to NSAIDs [Schmeltzer 2016]).

• Schmeltzer PA, Kosinski AS, Kleiner DE, Hoofnagle JH, Stolz A, Fontana RJ, Russo MW. , Drug-Induced Liver Injury Network (DILIN). Liver injury from nonsteroidal anti-inflammatory drugs in the United States. Liver Int. 2016;36:603–9. [PMC free article: PMC5035108] [PubMed: 26601797]

  (Among 1221 cases of drug induced liver injury enrolled in a prospective, US database between 2004 and 2014, 30 cases [2.5%] were attributed to NSAIDs, most commonly diclofenac [n=16], but also celecoxib [3], meloxicam [3], etodolac [2], ibuprofen [2], oxaprozin [2], valdecoxib [1] and sulindac [1]).

• Donati M, Conforti A, Lenti MC, Capuano A, Bortolami O, Motola D, Moretti U, et al. DILI-IT Study Group. Risk of acute and serious liver injury associated to nimesulide and other NSAIDs: data from drug-induced liver injury case-control study in Italy. Br J Clin Pharmacol. 2016;82:238–48. [PMC free article: PMC4917796] [PubMed: 26991794]

  (Among 179 cases of acute liver injury and 1770 controls admitted to 9 Italian hospitals between 2010 and 2014, NSAIDs used more frequently in cases compared to controls included nimesulide [17% vs 10%: odds ratio 1. 88] and ibuprofen [14% vs 10%: odds ratio 1.59] and risk was higher in those taking higher doses).

• Zoubek ME, González-Jimenez A, Medina-Cáliz I, Robles-Díaz M, Hernandez N, Romero-Gómez M, Bessone F, et al. High Prevalence of ibuprofen drug-induced Liver injury in Spanish and Latin-American registries. Clin Gastroenterol Hepatol. 2018;16:292–4. [PubMed: 28782674]

  (Analysis of a Spanish and Latin-American registries identified 73 cases of NSAID induced liver injury, the most common agents being nimesulide [38%], diclofenac [34%] and ibuprofen [17%]; other agents not mentioned).

• Tujios SR, Lee WM. Acute liver failure induced by idiosyncratic reaction to drugs: challenges in diagnosis and therapy. Liver Int. 2018;38:6–14. [PMC free article: PMC5741491] [PubMed: 28771932]

  (Review of acute liver failure and the contribution of drug induced liver injury, of which 5% were due to NSAIDs, most commonly diclofenac and etodolac).

• Meunier L, Larrey D. Recent advances in hepatotoxicity of non-steroidal anti-inflammatory drugs. Ann Hepatol. 2018;17:187–91. [PubMed: 29469052]

  (Review of the hepatotoxicity of NSAIDS mentions the most commonly implicated are diclofenac, nimesulide, sulindac, ibuprofen, piroxicam, naproxen and aspirin).

oxaprozin

All
FDA-approved
EMA-approved
PMDA-approved

Target Card Uniprot Example: P23975

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: oxaprozin alvo oxaprozin potassium WY 21743

An oxazole-propionic acid derivative, cyclooxygenase inhibitor, and non-steroidal anti-inflammatory drug that is used in the treatment of pain and inflammation associated with of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; and ARTHRITIS, JUVENILE. Molecular weight: 293.32 Formula: C18h25NO3 CLOGP: 2.95 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 63.33 ALOGS: -3.96 ROTB: 5 Status: OFP Legend: OFP – off patent OFM – off market ONP – on patent

Drug dosage:

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1.70 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	88. 64 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	98 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	490.75	22.07	237	2204	250773	50351910
Emotional distress	24.61	22. 07	16	2425	28647	50574036

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	551. 85	23.15	233	2136	237582	64258781
Emotional distress	27.77	23.15	17	2352	36021	64460342

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.

0.0

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGh3_HUMAN	INHIBITOR	IC50	4.44		IUPHAR	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGh2_HUMAN	INHIBITOR	IC50	6. 07		DRUG MATRIX	CHEMBL
fMet-Leu-Phe receptor	GPCR	P21462	FPR1_HUMAN					WOMBAT-PK
Bifunctional epoxide hydrolase 2	Enzyme	P34913	HYES_HUMAN	INHIBITOR	IC50	5.30		IUPHAR
Complement C5	Secreted	P01031	CO5_HUMAN		Kd	6.19		CHEMBL
Serine hydroxymethyltransferase, mitochondrial	Enzyme	P34897	GLYM_HUMAN		IC50	5.71		CHEMBL
Bifunctional epoxide hydrolase 2 [Includes: Cytosolic epoxide hydrolase 2	Enzyme		HYES_MOUSE		IC50	4.45		CHEMBL
Bifunctional epoxide hydrolase 2 [Includes: Cytosolic epoxide hydrolase 2	Enzyme		HYES_RAT		IC50	4. 20		CHEMBL

External reference:

Pharmaceutical products:

Oxaprozin – instructions for use

Oxaprozin

Instruction:

• Pharmacological action
• Readings
• Pregnancy and breastfeeding
• Dosage and Administration
• Classification

Pharmacological action

Oxaprozin is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties. Used to relieve inflammation, swelling, stiffness and joint pain associated with osteoarthritis and rheumatoid arthritis.

Indications

Deforming osteoarthritis, rheumatoid arthritis.

Pregnancy and lactation

Use in pregnancy

FDA fetal category C.

No adequate and well-controlled studies have been conducted on the safety of oxaprozin during pregnancy in humans.

Animal studies have revealed the following developmental anomalies: rare malformations have been observed at doses of 7.5 mg/kg/day or higher; testicular degeneration has been observed in beagle dogs treated with 37.5 mg/kg/day for 42 days or 6 months.

Oxaprozin, which belongs to the group of prostaglandin synthesis inhibitors, when taken during pregnancy, especially in the third trimester, may cause weak uterine contractions and premature closure of the ductus arteriosus. The use of prostaglandin synthesis inhibitors at an early stage of pregnancy can adversely affect the course of pregnancy.

In the event of pregnancy, absence of menstruation or suspected possible pregnancy, the patient should inform her doctor.

The use of oxaprozin is contraindicated in the third trimester of pregnancy. In the I and II trimesters, it is permissible to use it as directed by a doctor if the expected benefit to the mother outweighs the potential risk to the fetus.

Fertility

The use of NSAIDs may adversely affect fertility. Animal studies have shown that taking NSAIDs can suppress ovulation. In several cases of infertility in women taking NSAIDs, fertility was restored after their withdrawal. Before prescribing the drug to women trying to get pregnant, the benefit-risk ratio should be assessed.

Use during breastfeeding

Special studies on the safety of the use of oxaprozin during breastfeeding have not been conducted.

It is not known whether oxaprozin is excreted in human breast milk. Experimental studies have shown the release of oxaprozin into the milk of lactating animals. The effects in the infant are unknown.

Stop breastfeeding if using the drug.

Method of administration and doses

Adults, by mouth (used in the minimum effective dose)

Deforming osteoarthritis: 0.6-1.2 g 1 time per day.

Rheumatoid arthritis: 1.2 g once daily, maximum dose 1.8 g/day or 26 mg/kg/day.

Classification

• ATH

  M01AE12

• Pharmacological group

  NSAIDs – Derivatives of propionic acid

• FDA pregnancy category

  C
  (risk not excluded)

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More on the topic

Find out more about the active substance Oxaprozin:

• INN
• Reviews
• Questions
• Latin name
• Chemical formula

Information about the active substance Oxaprozin is intended for medical and pharmaceutical professionals, for reference purposes only. The instructions are not intended to replace professional medical advice, diagnosis or treatment. The information contained here may change over time. The most accurate information on the use of drugs containing the active substance Oxaprozin is contained in the manufacturer’s instructions attached to the package.

Oxaprozin | Side effects, dosage, uses and more

Highlights for Oxaprozin

1. Oxaprozin is an oral medication used to treat rheumatoid arthritis, juvenile rheumatoid arthritis and osteoarthritis.
2. This drug may increase the risk of heart problems such as heart attack and stroke. The risk may be higher the longer you take this drug.
3. Try to stay out of the sun while taking oxaprozin. You become more sensitive to the effects of the sun while taking this drug. If you cannot avoid the sun, wear sunscreen and protective clothing.
4. Oxaprozin may cause ulcers and stomach bleeding without symptoms. Smoking cigarettes or drinking alcohol can make these conditions worse.

IMPORTANT INFORMATION

FDA Warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). The black box warning alerts physicians and patients to potentially dangerous consequences.

• Risk of heart disease . Oxaprozin belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs may increase the risk of cardiovascular disease such as heart attack, heart failure, and stroke. Your risk may be higher if you take it long-term, at high doses, or if you already have heart problems or risk factors for heart disease, such as high blood pressure.
• May cause ulcers and bleeding in the stomach . Oxaprozin can cause ulcers and bleeding in the stomach and intestines. This can happen at any time during treatment and may not cause symptoms. Smoking cigarettes or drinking alcohol can make these conditions worse.
• Coronary Artery Bypass Surgery . Oxaprozin should not be used for pain after coronary bypass surgery. Taking this may increase the risk of heart attack or stroke.

May cause an allergic reaction

This medicine may cause a severe allergic reaction. Symptoms may include:

• hives
• breathing problems
• swelling of throat or tongue
• rash
• chest pain

Do not take oxaprozin if you have experienced any of these types of allergic reactions or asthma after taking aspirin or other NSAIDs.

May cause high blood pressure

Oxaprozin may cause high blood pressure in people who do not already have high blood pressure.

May cause kidney damage

Long term use of this drug may cause kidney damage. Seniors are at increased risk.

Indications for use

Oxaprozin is a prescription drug. It is available as a tablet to take by mouth. General version available. Usually drugs usually cost less. In some cases, they may not be available in every strength or form as a brand. Talk to your healthcare provider to see if the general principle will work for you.

Why it is used

Oxaprozin is used to treat the symptoms of rheumatoid arthritis, juvenile rheumatoid arthritis, and osteoarthritis.

How it works.

It is not clear how oxaprozin works. It belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs help reduce pain, inflammation, and fever.

NSAIDs can help reduce swelling by lowering levels of prostaglandin, a hormone that normally causes inflammation.

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Side effects

Side effects of oxaprozin

More common side effects

The most common side effects with oxaprozin include:

• diarrhea
• dizziness
• headache heartburn
• Serious side effects

If you experience any of these serious side effects, call your doctor right away.

If your symptoms are potentially life-threatening or if you think you are experiencing a medical emergency, call 9-1-1.

allergic reactions. Examples include:

• skin rash
  • itching or hives
  • swelling of your face, lips or tongue
  • heart problems. Symptoms may include:
• chest pain
  • unexplained weight gain or swelling
  • bleeding or peptic ulcers. Symptoms may include:
• severe stomach pain
  • nausea and vomiting
  • blood in urine or vomit
  • black or bloody stools
  • stroke. Symptoms may include:
• difficulty speaking
  • weakness on one side of your body
  • liver problems. Symptoms may include:
• yellowing of your skin or whites of your eyes
  • feeling unusually weak or tired
  • difficulty breathing or wheezing
• redness, blistering, peeling, or loosening of your skin, including on the inside of your mouth
• unusual bleeding or bruising
• Pharmacist’s advice Oxaprozin does not cause drowsiness.

Denial of responsibility

: Our goal is to provide you with the most current and up-to-date information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information does not replace medical advice. Always discuss possible side effects with a health care provider who knows your medical history . Advertising

Interaction

Oxaprozin may interact with other drugs

Oxaprozin may interact with other drugs, herbs or vitamins you may be taking. This is why your doctor must carefully manage all of your medications. If you are wondering how this drug might interact with something else you are taking, talk to your doctor or pharmacist.

You can lower your chances of drug interactions by listing all your prescriptions at one pharmacy. Thus, the pharmacist can check for possible drug interactions.

Alcohol interactions

Combining oxaprozin with alcohol increases the risk of ulcers or stomach ulcers.

Medicines that may interact with this drug

Non-steroidal anti-inflammatory drug

aspirin

• Taking aspirin and oxaprozin together may increase the toxic side effects from aspirin. These may include nausea, vomiting, sweating, and ringing in the ears.

Antirheumatic drug modifying diseases

methotrexate

• Combining these drugs can cause your body to have more than normal levels of methotrexate. This may cause more side effects, including nausea, vomiting, diarrhea, mouth ulcers, fever, and hair loss.

Blood pressure drugs

angiotensin-converting enzyme (ACE) inhibitors

• diuretics
• Oxaprozin may make your blood pressure medications ineffective.

Anticoagulant, thinner blood

warfarin

• The combination of these drugs increases the risk of gastrointestinal bleeding.

Disclaimer

: Our goal is to provide you with the most current and up-to-date information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information does not replace medical advice. Always talk to your health care provider about potential interactions with all prescription drugs, vitamins, herbs, and supplements, and over-the-counter drugs you take . Oxaprozin warnings

People with asthma

If you have aspirin-sensitive asthma and take oxaprozin, you are at increased risk of a severe, potentially fatal asthma attack. If you have asthma, which can be caused by aspirin, you should not use oxaprozin. Oxaprozin works similarly to aspirin .

People with liver disease

You may need to closely monitor or stop taking this drug if you have serious liver disease or have had abnormal liver test results. This drug is processed in the liver. If your liver function is reduced, you may not be able to process the drug as quickly. This can cause the drug to build up in your body, which can cause toxic side effects .

People with ulcer or stomach bleeding

This drug increases the risk of stomach or intestinal bleeding .

Pregnant women

Oxaprozin is a category C pregnancy drug. This means two things:

Animal studies have shown adverse effects on the fetus when the mother takes the drug.

1. There have not been enough human studies to be sure how this drug could affect the fetus.
2. Avoid taking this drug during the third trimester. This may harm your fetus.

Talk to your doctor if you are pregnant or planning to become pregnant before taking this drug.

Breastfeeding women

It is not known if oxaprozin passes through breast milk. If so, it may cause side effects in a child who is breastfed. You and your doctor can decide whether you will take oxaprozin or breastfeed .

Elderly

People over 65 may have reduced kidney function. This can lead to the formation of oxaprozin in the body, which can lead to toxic effects. If you are over 65, your doctor may start you on a lower dose of .

Children

For rheumatoid arthritis and osteoarthritis, the safety and efficacy of oxaprozin have not been established in people under 18 years of age .

Allergies

Oxaprozin may cause a severe allergic reaction. Symptoms may include:

swelling of the eyes, face, lips, throat, or tongue

• skin rash
• itching or hives
• swelling of the face, lips or tongue
• Do not take this drug again if you have ever had an allergic reaction to it. It may be dangerous to repeat.

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Dosage

How to take oxaprozin

All possible dosages and forms cannot be included here.

Your dose, form, and how often you take it will depend on:

your age

• a condition being treated
• how bad is your condition
• other medical conditions you have
• How do you react to the first dose of
• Why are you taking this drug?

Rheumatoid Arthritis

Brand:

Daypro Alta Shape:

Oral Tablet Strength:

600 mg Adult dose (age 18 years and over)

two 600 mg tablets taken once a day .

• If you cannot tolerate this amount in one dose, your doctor may change your dose to one 600 mg tablet taken twice daily as needed.
• Do not exceed 1,800 mg per day or 26 mg/kg per day, whichever is less.
• If you weigh less than 110 pounds (50 kg) or have mild arthritis, your doctor may start you at 600 mg once a day. This may reduce the risk of side effects.
• Child dosage (ages 0-17)

A safe and effective dose has not been determined for this use of .

Warnings

Oxaprozin is approved for use in children with juvenile rheumatoid arthritis. It should not be used in children for other conditions.

Osteoarthritis

Brand:

Daypro Alta Shape:

Oral tablet Strength:

600 mg Adult dose (ages 18 and over)

two 600 mg tablets taken once a day .

• If you cannot tolerate this amount in one dose, your doctor may change your dose to one 600 mg tablet taken twice daily as needed.
• Do not exceed 1,800 mg per day or 26 mg/kg per day, whichever is less.
• If you weigh less than 110 pounds (50 kg) or have mild arthritis, your doctor may start you at 600 mg once a day. This may reduce the risk of side effects.
• Child dosage (ages 0-17)

A safe and effective dose has not been determined for this use of .

Warnings

Oxaprozin is approved for use in children with juvenile rheumatoid arthritis. It should not be used in children for other conditions.

Disclaimer

: Our goal is to provide you with the most current and up-to-date information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible doses. This information does not replace medical advice. Always talk to your doctor or pharmacist about dosages that are right for you . Juvenile Rheumatoid Arthritis

Brand:

Daypro Alta Form:

Oral Tablet Strength:

600mg 901 32 Child dosage (ages 0-17 years)

Children’s dosage is based on their weight .

• 48-69 lbs (22-31 kg): Take one 600 mg tablet once daily.
• 70-120 lbs (32-54 kg): Take one and half of a 600 mg tablet for a total dose of 900 mg once a day.
• 121 lbs or more (55 kg or more): Take two 600 mg tablets once daily.
• Warnings

Oxaprozin is approved for use in children with juvenile rheumatoid arthritis. It should not be used in children for other conditions.

Disclaimer

: Our goal is to provide you with the most current and up-to-date information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible doses. This information does not replace medical advice. Always talk to your doctor or pharmacist about dosages that are right for you . Pharmacist advice

If you stop or miss doses If you stop taking this drug, skip doses, or don’t take it as scheduled, your arthritis symptoms may get worse .

If you take too much

If you take too much oxaprozin you may experience:

• stomach pain • stomach bleeding

Rarely, it can cause dangerous allergic reactions, high blood pressure, kidney failure, difficulty breathing or coma. Seek medical attention right away if you are taking or think you are taking too much oxaprozin.

What to do if you miss a dose

If you miss a dose, take it as soon as you remember. However, if it is only a few hours before the next dose, wait and take the single dose at the usual time. Never try to catch up by taking two pills at once. This can lead to toxic side effects.

How can I find out if a drug is working?

You can say this drug works if your pain or swelling gets better.

Oxaprozin is a short-term drug .

Important considerations for taking oxaprozin

You can take this drug with or without food

Taking this with food can limit indigestion.

You can cut or crush an oral tablet

Store between 59 and 86°F (15-30°C)

Keep container tightly closed. Protect this drug from light. After the expiration date, throw away all unused medicines.

Multidose prescription

When traveling with your medicine:

Always carry it with you or in your carry bag.

Don’t worry about airport x-ray machines. They cannot harm this drug.

• You may need to show your pharmacy’s pre-printed label to identify the drug. When traveling, keep the original labeled bottle labeled with the recipe.
• Your doctor will do tests to check your health and make sure the drug is working for you. These include:
• blood test

kidney function test

• liver function test
• sun sensitivity
• Oxaprozin may make you more sensitive to the sun. If you cannot avoid the sun, wear protective clothing and use sunscreen.

Insurance

Many insurance companies will need prior approval before they can approve a prescription and pay for oxaprozin.

Disclaimer: Healthline has made every effort to ensure that all information is, in fact, correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and experience of a licensed healthcare professional. You should always consult your physician or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions.