pharmacopeia
GET
/api/v1/drug/piroxicam

Boxed warning

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic 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 Warnings and Precautions (5.1) ] . • Piroxicam capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (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 GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

2D structure
4-hydroxy-2-methyl-1,1-dioxo-N-pyridin-2-yl-1lambda6,2-benzothiazine-3-carboxamide
SMILES CN1C(=C(C2=CC=CC=C2S1(=O)=O)O)C(=O)NC3=CC=CC=N3
InChIKey QYSPLQLAKJAUJT-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

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).

Cyclooxygenase

Indications

Sourced from openFDA
  • Piroxicam capsules are indicated: • For relief of the signs and symptoms of osteoarthritis. • For relief of the signs and symptoms of rheumatoid arthritis.ICD-10: M06.9, M19.90

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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 )

Warnings & precautions

Sourced from openFDA

• Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) • Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) • Heart Failure and Edema : Avoid use of piroxicam capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) • Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of piroxicam capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) • Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) • Exacerbation of Asthma Related to Aspirin Sensitivity : Piroxicam capsules are contraindicated in patients with aspirin-sensitive asthma.

Adverse reactions

Sourced from openFDA

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 (5.11) ] 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 Nostrum Laboratories, Inc. at quality@nostrumpharma.com or 1-877-770-1288 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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.

Use in specific populations

Sourced from openFDA

Pregnancy : Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation ( 5.10 , 8.1 ) 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, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of piroxicam capsules in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. 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.

Pharmacokinetics

Sourced from openFDA
Metabolism
General Pharmacokinetic Characteristics The pharmacokinetics of piroxicam have been characterized in healthy subjects, special populations and patients. The pharmacokinetics of piroxicam are linear.

Overdosage

Sourced from openFDA

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 NSAID overdose. There are no specific antidotes. 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 osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). 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. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

Approval history

Sourced from openFDA
  • Dec 11, 1992ANDAANDA074131Teva
  • Apr 13, 2017ANDAANDA208340Unichem
  • Dec 29, 2017ANDAANDA206152Micro Labs
  • Jan 26, 2018ANDAANDA210347Strides Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
6,275 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Hypersensitivity96515%
  2. 2Rash90814%
  3. 3Arthralgia89714%
  4. 4Condition Aggravated89214%
  5. 5Drug Ineffective85614%
  6. 6Rheumatoid Arthritis84113%
  7. 7Fatigue83913%
  8. 8Diarrhoea83613%
  9. 9Pain82813%
  10. 10Nausea81213%
  11. 11Psoriatic Arthropathy81013%
  12. 12Sinusitis79613%
  13. 13Sciatica75712%
  14. 14Off Label Use75512%
  15. 15Headache73912%

Literature

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Recent PubMed references pinned to Piroxicam as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 37 ClinicalTrials.gov registrations naming Piroxicam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Piroxicam. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Piroxicam work?
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).
What is Piroxicam used for?
According to FDA labeling, Piroxicam carries indications including: Piroxicam capsules are indicated: • For relief of the signs and symptoms of osteoarthritis. • For relief of the signs and symptoms of rheumatoid arthritis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Piroxicam?
Piroxicam is classified as Antiinflammatory agents, non-steroids, Antiinflammatory preparations, non-steroids for topical use, Oxicams, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production.
What are the brand names for Piroxicam?
Piroxicam is marketed under brand names including Feldene.
What are the contraindications for Piroxicam?
Piroxicam labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for piroxicam is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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