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Piroxicam
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Piroxicam | 10 mg/1 | 198107 | — |
| Piroxicam | 20 mg/1 | 198107 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 210347-001 | PIROXICAM | CAPSULE | PIROXICAM | Prescription | AB | ||
| 210347-002 | PIROXICAM | CAPSULE | PIROXICAM | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 7 | Labeling | Approved | June 25, 2026 | Standard |
| Supplement | 5 | Labeling | Approved | February 3, 2023 | Standard |
| Supplement | 4 | Labeling | Approved | August 16, 2022 | Standard |
| Supplement | 3 | Labeling | Approved | August 16, 2022 | Standard |
| Supplement | 2 | Labeling | Approved | December 23, 2019 | Standard |
| Original application | 1 | Approved | January 26, 2018 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260819). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Card iovascu lar Thrombot ic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. [see Warn ings and Precau tions ( 5.1 )] . • Piroxicam is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Con tra ind ica tions ( 4 ) and Warn ings and Precau tions ( 5.1 )]. Gastrointestinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions ( 5.2 )]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTR OINTESTINAL EVENTS See full prescribing in for mation for co mplete boxed warning. • Nonsteroidal anti-infla mmatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thro mbo tic even ts, including myocardial infarction and stro ke, which can be f atal. This risk may occur early in treat ment and may increase with duration of use ( 5.1 ) • Piroxicam is contraindicated in the setting of coron ary artery bypass gra ft (CAB G) surgery ( 4 , 5 .1 ) • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the sto mach or intestines, which can be fatal. These events can occur at any ti me during use and without warning sy m pto ms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 )
Recent Major Changes
openFDA Drug LabelingRECENT MAJOR CHANGES Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (5.10) 4/2021 Warnings and Precautions, Fetal Toxicity (5.11) 4/2021
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Piroxicam capsule, is indicated: • For relief of the signs and symptoms of osteoarthritis. • For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam capsule,is a nonste roidal anti -infla mmato ry d rug indicated for • Relief of the signs and sy mpt o ms of osteoarthritis (OA) • Relief of the signs and sy mpto ms of rheu m atoid arthritis (RA)
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ] . After observing the response to initial therapy with piroxicam capsules, the dose and frequency should be adjusted to suit an individual patient’s needs. For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of piroxicam capsules, steady-state blood levels are not reached for 7 to 12 days. Therefore, although the therapeutic effects of piroxicam capsules are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks. • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2 ) • OA and RA: 20 mg once daily ( 2 )
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Piroxicam Capsules, USP are available containing 10 mg or 20 mg of piroxicam, USP. • The 10 mg capsule is a hard gelatin capsule with a swedish orange opaque cap and ivory opaque body containing white to off-white powder. The capsule is imprinted with NP above 10 in black ink on the cap. • The 20 mg capsule is a hard gelatin capsule with a swedish orange opaque cap and swedish orange opaque body containing white to off-white powder. The capsule is imprinted with NP above 20 in black ink on the cap. Piroxicam capsules: 10 mg and 20 mg ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Piroxicam capsules are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 )] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.8 )] • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 ) ] • Known hypersensitivity to piroxicam or any components of the drug product ( 4 ) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) • In the setting of CABG surgery ( 4 )
Warnings and Cautions
openFDA Drug Labeling5.1 Cardiovascular Thrombotic Events Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as piroxicam, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2)]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see Contraindications (4)]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of Piroxicam Capsules in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Piroxicam Capsules are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. 5.2 Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including piroxicam capsules, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term NSAID therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS Most common adverse reactions (incidence >2% from clinical trials) are: nausea, constipation, flatulence, abdominal pain, diarrhea, headache, dizziness, edema, rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Heart Failure and Edema [see Warnings and Precautions (5.5 )] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)] Anaphylactic Reactions [see Warnings and Precautions (5.7)] Serious Skin Reactions [see Warnings and Precautions (5.9)] Hematologic Toxicity [see Warnings and Precautions (5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients taking Piroxicam Capsules or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are: Cardiovascular System: Edema Digestive System: Anorexia, abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting Nervous System: Dizziness, headache, vertigo Skin and Appendages: Pruritus, rash Special Senses: Tinnitus Additional adverse experiences reported occasionally include: Cardiovascular System: Palpitations Digestive System: Stomatitis Nervous System: Drowsiness Special Senses: Blurred vision 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of Piroxicam Capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole : Fever, infection, sepsis, anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope, arrhythmia, exacerbation of angina, hypotension, myocardial infarction, vasculitis Digestive System: Dyspepsia, elevated liver enzymes, gross bleeding/perforation, heartburn, ulcers (gastric/duodenal), dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, eructation, liver failure, pancreatitis Hemic and Lymphatic System: Anemia, increased bleeding time, ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia Hypersensitivity: Positive ANA Metabolic and Nutritional: Weight changes, Fluid retention, hyperglycemia, hypoglycemia Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, akathisia, convulsions, coma, hallucinations, meningitis, mood alterations Respiratory System: Asthma, dyspnea, respiratory depression, pneumonia Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens Johnson Syndrome, urticaria, vesiculobullous reaction Special Senses: Conjunctivitis, hearing impairment, swollen eyes Urogenital System: Abnormal renal function, cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure, glomerulonephritis Reproductive System and Breast Disorders: Female fertility decreased To report SUSPECTED ADVERSE …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with piroxicam. Table 1: Clinically Significant Drug Interactions with Piroxicam Drugs That Interfere with Hemostasis Clinical Impact: • Piroxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of piroxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of piroxicam capsules with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions ( 5.11 )] . Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions ( 5.2 )] . Intervention: Concomitant use of piroxicam capsules and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions ( 5.11 )] . Piroxicam capsules are not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: • During concomitant use of piroxicam capsules and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. • During concomitant use of piroxicam capsules and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions ( 5.6 )]. • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of piroxicam capsules with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions ( 5.6 )] . Digoxin Clinical Impact: The concomitant use of piroxicam with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of piroxicam capsules and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSA …
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of Piroxicam Capsules in women who have difficulties conceiving (8.3) 8.1 Pregnancy Risk Summary Use of NSAIDs, including Piroxicam Capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Piroxicam Capsules use between about 20 and 30 weeks of gestation, and avoid Piroxicam Capsules use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including Piroxicam Capsules, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 and 10 times the maximum recommended human dose (MRHD), respectively. In rat studies with piroxicam, fetotoxicity (postimplantation loss) was observed at exposures 2 times the MRHD, and delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of piroxicam. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as piroxicam, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including Piroxicam Capsules, can cause premature closure of the fetal ductus arteriosus ( see Data ). Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If Piroxicam Capsules treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Piroxicam Capsules and follow up according to clinical practice ( see Data ). Labor or Delivery There are no studies on the effects of Piroxicam Capsules during labor or delivery. In animal studies, NSAIDS, including piroxicam inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in preg …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Piroxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Piroxicam Capsules, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Piroxicam is a potent inhibitor of prostaglandin (PG) synthesis in vitro . Piroxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because piroxicam is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Description
openFDA Drug Labeling11 DESCRIPTION Piroxicam capsules, USP are a nonsteroidal anti-inflammatory drug, available as dark green and olive 10 mg capsules and dark green 20 mg capsules, for oral administration. The chemical name is 4-hydroxyl-2-methyl- N -2-pyridinyl-2 H -1,2,-benzothiazine-3-carboxamide 1,1-dioxide. It has the following structural formula: C 15 H 13 N 3 O 4 S M.W. 331.35 Piroxicam, USP occurs as an off-white to light tan or light yellow powder, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous alkaline solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in piroxicam capsules, USP include: colloidal silicon dioxide, corn starch, D&C Yellow No. 10, FD&C Green No. 3, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and titanium dioxide. The imprinting ink contains propylene glycol, shellac and titanium dioxide. The 10 mg capsule also contains: ammonium hydroxide, black iron oxide, FD&C Blue No. 1, simethicone (which contains dimethicone and silicon dioxide), and yellow iron oxide. chemical-structure.jpg
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Symptoms following acute NSAID overdoses have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.6 )] . Manage patients with symptomatic and supportive care following an acute NSAID overdose. There are no specific antidotes. It is advisable to contact a poison control center (1-800-222-1222) to determine the latest recommendations because strategies for the management of overdose are continually evolving. If gastric decontamination may be potentially beneficial to the patient, e.g., short time since ingestion or a large overdosage (5 to 10 times the recommended dosage), consider emesis and/or activated charcoal (60 grams to 100 grams in adults, 1 gram to 2 grams per kg of body weight in pediatric patients) and/or an osmotic cathartic in symptomatic patients. The long plasma half-life of piroxicam should be considered when treating an overdose with piroxicam. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Piroxicam Capsules USP for oral administration: Piroxicam capsules USP, 10 mg are maroon opaque cap with imprinting 'PR' and blue opaque body with imprinting '10', size “4” hard gelatin capsules filled with off-white to light tan or light yellow powder. Bottles of 15 NDC 42571-176-15 Bottles of 100 NDC 42571-176-01 Bottles of 500 NDC 42571-176-05 Bottles of 1000 NDC 42571-176-10 Piroxicam capsules USP, 20 mg are maroon opaque cap with imprinting 'PR' and maroon opaque body with imprinting '20', size “2” hard gelatin capsules filled with off-white to light tan or light yellow powder. Bottles of 15 NDC 42571-177-15 Bottles of 100 NDC 42571-177-01 Bottles of 500 NDC 42571-177-05 Bottles of 1000 NDC 42571-177-10 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: PIROXICAM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 42291-953-01 | 42291-953 | AvKARE | 100 CAPSULE in 1 BOTTLE (42291-953-01) | August 1, 2024 |
| 42291-954-01 | 42291-954 | AvKARE | 100 CAPSULE in 1 BOTTLE (42291-954-01) | August 1, 2024 |
| 42291-954-50 | 42291-954 | AvKARE | 500 CAPSULE in 1 BOTTLE (42291-954-50) | August 1, 2024 |
| 63629-9148-1 | 63629-9148 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE, PLASTIC (63629-9148-1) | January 26, 2022 |
| 63629-9149-1 | 63629-9149 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE, PLASTIC (63629-9149-1) | January 26, 2022 |
| 63629-9150-1 | 63629-9150 | Bryant Ranch Prepack | 500 CAPSULE in 1 BOTTLE, PLASTIC (63629-9150-1) | January 26, 2022 |
| 71335-1999-1 | 71335-1999 | Bryant Ranch Prepack | 10 CAPSULE in 1 BOTTLE (71335-1999-1) | April 3, 2024 |
| 71335-1999-2 | 71335-1999 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-1999-2) | November 23, 2021 |
| 71335-1999-3 | 71335-1999 | Bryant Ranch Prepack | 7 CAPSULE in 1 BOTTLE (71335-1999-3) | April 3, 2024 |
| 71335-1999-4 | 71335-1999 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-1999-4) | April 3, 2024 |
| 71335-1999-5 | 71335-1999 | Bryant Ranch Prepack | 20 CAPSULE in 1 BOTTLE (71335-1999-5) | April 3, 2024 |
| 71335-1999-6 | 71335-1999 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-1999-6) | April 3, 2024 |
| 71335-1999-7 | 71335-1999 | Bryant Ranch Prepack | 180 CAPSULE in 1 BOTTLE (71335-1999-7) | April 3, 2024 |
| 71335-1999-8 | 71335-1999 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-1999-8) | April 3, 2024 |
| 71335-2067-1 | 71335-2067 | Bryant Ranch Prepack | 10 CAPSULE in 1 BOTTLE (71335-2067-1) | March 29, 2022 |
| 71335-2067-2 | 71335-2067 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2067-2) | March 29, 2022 |
| 71335-2067-3 | 71335-2067 | Bryant Ranch Prepack | 7 CAPSULE in 1 BOTTLE (71335-2067-3) | March 29, 2022 |
| 71335-2067-4 | 71335-2067 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2067-4) | March 29, 2022 |
| 71335-2067-5 | 71335-2067 | Bryant Ranch Prepack | 20 CAPSULE in 1 BOTTLE (71335-2067-5) | March 29, 2022 |
| 71335-2067-6 | 71335-2067 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2067-6) | March 29, 2022 |
| 71335-2067-7 | 71335-2067 | Bryant Ranch Prepack | 180 CAPSULE in 1 BOTTLE (71335-2067-7) | March 29, 2022 |
| 71335-2067-8 | 71335-2067 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-2067-8) | March 29, 2022 |
| 71335-9622-1 | 71335-9622 | Bryant Ranch Prepack | 10 CAPSULE in 1 BOTTLE (71335-9622-1) | January 9, 2023 |
| 71335-9622-2 | 71335-9622 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-9622-2) | January 9, 2023 |
| 71335-9622-3 | 71335-9622 | Bryant Ranch Prepack | 7 CAPSULE in 1 BOTTLE (71335-9622-3) | January 9, 2023 |
| 71335-9622-4 | 71335-9622 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-9622-4) | January 9, 2023 |
| 71335-9622-5 | 71335-9622 | Bryant Ranch Prepack | 20 CAPSULE in 1 BOTTLE (71335-9622-5) | January 9, 2023 |
| 71335-9622-6 | 71335-9622 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-9622-6) | January 9, 2023 |
| 71335-9622-7 | 71335-9622 | Bryant Ranch Prepack | 180 CAPSULE in 1 BOTTLE (71335-9622-7) | January 9, 2023 |
| 71335-9622-8 | 71335-9622 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-9622-8) | January 9, 2023 |
| 72162-1290-1 | 72162-1290 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE, PLASTIC (72162-1290-1) | March 11, 2024 |
| 72162-1291-1 | 72162-1291 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE, PLASTIC (72162-1291-1) | March 11, 2024 |
| 72162-1291-5 | 72162-1291 | Bryant Ranch Prepack | 500 CAPSULE in 1 BOTTLE, PLASTIC (72162-1291-5) | March 11, 2024 |
| 72189-350-60 | 72189-350 | Direct_Rx | 60 CAPSULE in 1 BOTTLE (72189-350-60) | April 27, 2023 |
| 42571-176-01 | 42571-176 | Micro Labs Limited | 100 CAPSULE in 1 BOTTLE (42571-176-01) | March 1, 2018 |
| 42571-176-05 | 42571-176 | Micro Labs Limited | 500 CAPSULE in 1 BOTTLE (42571-176-05) | March 1, 2018 |
| 42571-176-10 | 42571-176 | Micro Labs Limited | 1000 CAPSULE in 1 BOTTLE (42571-176-10) | March 1, 2018 |
| 42571-176-15 | 42571-176 | Micro Labs Limited | 15 CAPSULE in 1 BOTTLE (42571-176-15) | March 1, 2018 |
| 42571-177-01 | 42571-177 | Micro Labs Limited | 100 CAPSULE in 1 BOTTLE (42571-177-01) | March 1, 2018 |
| 42571-177-05 | 42571-177 | Micro Labs Limited | 500 CAPSULE in 1 BOTTLE (42571-177-05) | March 1, 2018 |
| 42571-177-10 | 42571-177 | Micro Labs Limited | 1000 CAPSULE in 1 BOTTLE (42571-177-10) | March 1, 2018 |
| 42571-177-15 | 42571-177 | Micro Labs Limited | 15 CAPSULE in 1 BOTTLE (42571-177-15) | March 1, 2018 |
| 72789-210-01 | 72789-210 | PD-Rx Pharmaceuticals, Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-210-01) | October 27, 2021 |
| 72789-211-01 | 72789-211 | PD-Rx Pharmaceuticals, Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-211-01) | October 27, 2021 |
| 71205-032-30 | 71205-032 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE, PLASTIC (71205-032-30) | May 1, 2018 |
| 71205-032-60 | 71205-032 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE, PLASTIC (71205-032-60) | May 1, 2018 |
| 71205-032-90 | 71205-032 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE, PLASTIC (71205-032-90) | May 1, 2018 |
| 71205-203-30 | 71205-203 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (71205-203-30) | January 1, 2019 |
| 71205-203-60 | 71205-203 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (71205-203-60) | January 1, 2019 |
| 71205-203-90 | 71205-203 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (71205-203-90) | January 1, 2019 |
| 64380-842-06 | 64380-842 | Strides Pharma Science Limited | 100 CAPSULE in 1 BOTTLE (64380-842-06) | May 7, 2018 |
| 64380-843-06 | 64380-843 | Strides Pharma Science Limited | 100 CAPSULE in 1 BOTTLE (64380-843-06) | May 7, 2018 |
| 64380-843-07 | 64380-843 | Strides Pharma Science Limited | 500 CAPSULE in 1 BOTTLE (64380-843-07) | May 9, 2018 |
| 0093-0756-01 | 0093-0756 | Teva Pharmaceuticals USA, Inc. | 100 CAPSULE in 1 BOTTLE (0093-0756-01) | October 19, 1994 |
| 0093-0757-01 | 0093-0757 | Teva Pharmaceuticals USA, Inc. | 100 CAPSULE in 1 BOTTLE (0093-0757-01) | January 26, 1994 |
| 0093-0757-05 | 0093-0757 | Teva Pharmaceuticals USA, Inc. | 500 CAPSULE in 1 BOTTLE (0093-0757-05) | January 26, 1994 |
| 29300-255-01 | 29300-255 | Unichem Pharmaceuticals (USA), Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (29300-255-01) | August 1, 2017 |
| 29300-255-05 | 29300-255 | Unichem Pharmaceuticals (USA), Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-255-05) | August 1, 2017 |
| 29300-256-01 | 29300-256 | Unichem Pharmaceuticals (USA), Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (29300-256-01) | August 1, 2017 |
| 29300-256-05 | 29300-256 | Unichem Pharmaceuticals (USA), Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-256-05) | August 1, 2017 |
| 29300-256-13 | 29300-256 | Unichem Pharmaceuticals (USA), Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (29300-256-13) | August 1, 2017 |
| 42291-953 | 42291-953 | AvKARE | — | August 1, 2024 |
| 42291-954 | 42291-954 | AvKARE | — | August 1, 2024 |
| 63629-9148 | 63629-9148 | Bryant Ranch Prepack | — | February 20, 2020 |
| 63629-9149 | 63629-9149 | Bryant Ranch Prepack | — | February 20, 2020 |
| 63629-9150 | 63629-9150 | Bryant Ranch Prepack | — | February 20, 2020 |
| 71335-1999 | 71335-1999 | Bryant Ranch Prepack | — | August 1, 2017 |
| 71335-2067 | 71335-2067 | Bryant Ranch Prepack | — | May 7, 2018 |
| 71335-9622 | 71335-9622 | Bryant Ranch Prepack | — | March 1, 2018 |
| 72162-1290 | 72162-1290 | Bryant Ranch Prepack | — | February 20, 2020 |
| 72162-1291 | 72162-1291 | Bryant Ranch Prepack | — | February 20, 2020 |
| 72189-350 | 72189-350 | Direct_Rx | — | April 27, 2023 |
| 42571-176 | 42571-176 | Micro Labs Limited | — | March 1, 2018 |
| 42571-177 | 42571-177 | Micro Labs Limited | — | March 1, 2018 |
| 72789-210 | 72789-210 | PD-Rx Pharmaceuticals, Inc. | — | May 7, 2018 |
| 72789-211 | 72789-211 | PD-Rx Pharmaceuticals, Inc. | — | May 7, 2018 |
| 71205-032 | 71205-032 | Proficient Rx LP | — | September 28, 2017 |
| 71205-203 | 71205-203 | Proficient Rx LP | — | March 1, 2018 |
| 64380-842 | 64380-842 | Strides Pharma Science Limited | — | May 7, 2018 |
| 64380-843 | 64380-843 | Strides Pharma Science Limited | — | May 7, 2018 |
| 0093-0756 | 0093-0756 | Teva Pharmaceuticals USA, Inc. | — | October 19, 1994 |
| 0093-0757 | 0093-0757 | Teva Pharmaceuticals USA, Inc. | — | January 26, 1994 |
| 29300-255 | 29300-255 | Unichem Pharmaceuticals (USA), Inc. | — | August 1, 2017 |
| 29300-256 | 29300-256 | Unichem Pharmaceuticals (USA), Inc. | — | August 1, 2017 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.