fenoprofen (Rx)

>10%

Dyspepsia (10.3%)

Somnolence

Increased LFT

1-10%

Abdominal pain

Anemia

Diarrhea

Dizziness

Edema

Headache

Constipation

Confusion

Tremor

Sweating

Tinnitus

Blurred vision

Palpitations

Nervousness

Fatigue

Rash

Nausea

Vomiting

GI bleeding, ulceration, perforation

Frequency Not Defined

Insomnia

Asthenia

Paresthesia

Muscle weakness

Decreased hearing

Purpura, bruising, hemorrhage

Thrombocytopenia, hemolytic anemia, aplastic anemia, agranulocytosis, pancytopenia, slight decreases in hemoglobin concentration & hematocrit

Dysuria, cystitis, hematuria

Nephrotic syndrome, renal failure, oliguria, anuria, azotemia, allergic nephritis, nephrosis, papillary necrosis

Jaundice

Cholestatic hepatitis

Contraindications

Absolute: ASA allergy

Relative: bleeding disorders, duodenal/gastric/peptic ulcer, renal impairment, stomatitis, SLE, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)

Cautions

Use caution in asthma (bronchial), cardiac disease, CHF, hepatic impairment, HTN

Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs

Heart Failure (HF) risk

• NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
• NSAIDS should be avoided or withdrawn whenever possible
• AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Pregnancy Category: C; avoid during third trimester, may cause premature closure of the ductus arteriosus

The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)

Lactation: excretion in milk unknown/not recommended

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase isoenzymes, cyclooxygenase-1 (COX-1) and -2 (COX-2)

May inhibit chemotaxis, may alter lymphocyte activity, decrease proinflammatory cytokine activity, and may inhibit neutrophil aggregation. These effects may contribute to its anti-inflammatory activity

Pharmacokinetics

Onset: 2-4hr

Duration: 4-6 hr

Peak Plasma Time: 2 hr

Peak Plasma Concentration: 50 mcg/mL

Protein Bound: 99% (albumin)

Metabolism: Liver

Metabolites: 4'-hydroxyfenoprofen, glucuronic acid conjugates

Enzymes inhibited: cyclooxygenase-1 (COX-1) & -2 (COX-2), prostaglandin synthesis

Half-life: 2.5-3 hr

Clearance: within 24 hr

Excretion: urine (primarily); feces