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Drug reference

Nimesulide

Selective COX-2 inhibitor (sulfonanilide NSAID) · Anti-inflammatory, Antipyretic, Analgesic

START
100 mg PO twice daily for ≤15 days
TYPICAL MAX
200 mg/day for ≤15 days
STOP IF
Any hepatic enzyme rise, jaundice, GI bleed, AKI, or rash
WATCH
LFTs at baseline (and during use if prolonged); GI symptoms; renal function
CDSCO approvedSchedule HATC M01AX17
Dose laddermg/d
100per dose200max/day
Renal dose adjustmenteGFR mL/min/1.73m²
CAUTIONUsual short-term use60REDUCEReduce dose; short course only30AVOIDAvoid90

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
30minONSET2hPEAK3.5h7hDURATION
ONSET
30min · absorption
PEAK
2h · Tmax
3.5h ·
DURATION
7h · per dose
EXCRETION
Renal — mainly metabolites
route + CYP
INTERACTIONS
4 major
SEVERE in our sources
PREGNANCY
Avoid; 3rd trimester contraindicated.
FDA category + note
Top interactionssee all 12
  • LithiumSevereDatabaseKimi deep-research + Cla
  • AnticoagulantsSevereDatabaseKimi deep-research + Cla
  • Other Hepatotoxic DrugsSevereDatabaseKimi deep-research + Cla
  • WarfarinSevereDatabase

Mechanism

Selective COX-2 inhibitor with additional anti-inflammatory actions (reduced PMN activation, scavenging of reactive oxygen species) — analgesic, antipyretic, and anti-inflammatory; preferential COX-2 selectivity less than coxibs.

Indications

Acute pain (musculoskeletal, dysmenorrhoea, dental — short-term ≤15 days)Osteoarthritis (short-term)Fever (regions where licensed)

Dosing

Adult
100 mg PO twice daily for ≤15 days; do not exceed treatment duration.
Pediatric
Generally not recommended; FEVER in <12 y contraindicated.
Renal adjustment
Reduce in significant impairment; avoid severe.
Hepatic adjustment
Contraindicated in any hepatic impairment.
Geriatric
Lower doses; GI/hepatic/renal risk.
Max dose
200 mg/day for ≤15 days

Pharmacokinetics

Onset
Analgesia ~30 min
Peak effect
~2 h (Tmax)
Duration
~6–8 h
Half-life
~2–5 h
Bioavailability
Well absorbed orally
Protein binding
>99%
Metabolism
Hepatic (active hydroxy metabolite)
Excretion
Renal (mainly metabolites)

Contraindications

  • Active GI ulcer / bleeding
  • Hepatic impairment (any) — significant hepatotoxicity signal
  • Severe heart failure
  • Severe renal impairment
  • Third trimester pregnancy
  • Fever in children <12 y
  • Hypersensitivity / aspirin-asthma triad

Side effects

Common
Nausea / dyspepsiaDiarrhoeaHeadacheDizzinessRash
Serious
  • Hepatotoxicity (severe — withdrawal reason in many countries)
  • Acute liver failure
  • GI bleeding / ulcer
  • AKI
  • Severe skin reactions (SJS/TEN)
  • Reye-like syndrome in children

Pregnancy & lactation

Pregnancy

Avoid; 3rd trimester contraindicated.

Lactation

Avoid (limited data; safer alternatives).

Drug interactions

Lithium
Severe
Database

Reduced renal clearance

Monitor levels

Source: Kimi deep-research + Cla

Anticoagulants
Severe
Database

Additive bleeding (selective-COX-2 less than non-selective NSAID, still significant)

Avoid; gastroprotection

Source: Kimi deep-research + Cla

Other Hepatotoxic Drugs
Severe
Database

Additive hepatic injury

Avoid stacking; nimesulide already withdrawn in many countries for hepatotoxicity

Source: Kimi deep-research + Cla

Warfarin
Severe
Database

Increased risk of bleeding (gastrointestinal, other sites), increased INR

Avoid concomitant use. If unavoidable, monitor INR very closely and adjust warfarin dose. Consider alternative analgesics.

Ace Inhibitors (e.g., Enalapril, Ramipril)
Moderate
Database

Reduced antihypertensive effect, increased risk of renal impairment (especially in dehydrated or elderly patients), potential for hyperkalemia.

Monitor blood pressure and renal function (creatinine, electrolytes). Ensure adequate hydration. Avoid in patients with pre-existing renal dysfunction. Consider alternative analgesics.

Angiotensin Receptor Blockers (arbs) (e.g., Losartan, Telmisartan)
Moderate
Database

Reduced antihypertensive effect, increased risk of renal impairment (especially in dehydrated or elderly patients), potential for hyperkalemia.

Monitor blood pressure and renal function (creatinine, electrolytes). Ensure adequate hydration. Avoid in patients with pre-existing renal dysfunction. Consider alternative analgesics.

Aspirin (low Dose)
Moderate
Database

Increased risk of gastrointestinal bleeding and ulceration. Nimesulide may interfere with aspirin's antiplatelet effect if taken concurrently.

Avoid concomitant use if possible. If unavoidable, monitor for signs of bleeding. Consider a proton pump inhibitor (PPI) for gastroprotection. Administer nimesulide at least 2 hours after aspirin.

Corticosteroids (e.g., Prednisolone)
Moderate
Database

Increased risk of gastrointestinal ulceration and bleeding.

Use with caution. Consider a proton pump inhibitor (PPI) for gastroprotection, especially in patients with a history of GI issues.

Cyclosporine
Moderate
Database

Increased risk of nephrotoxicity and renal impairment.

Avoid concomitant use. If unavoidable, monitor renal function (creatinine, BUN) closely. Consider alternative analgesics.

Diuretics (e.g., Furosemide, Hydrochlorothiazide)
Moderate
Database

Reduced diuretic and antihypertensive effect, increased risk of renal impairment (especially in dehydrated or elderly patients).

Monitor blood pressure and renal function (creatinine, electrolytes). Ensure adequate hydration. Consider alternative analgesics if renal risk is high.

Methotrexate
Moderate
Database

Increased plasma concentrations of methotrexate, leading to methotrexate toxicity (myelosuppression, mucositis, renal failure).

Avoid concomitant use, especially with high-dose methotrexate. If unavoidable, monitor methotrexate levels and signs of toxicity. Consider alternative analgesics.

Ace Inhibitors
Moderate
Database

Triple-whammy AKI

Monitor renal function

Source: Kimi deep-research + Cla

Related guidelines

Ask House about Nimesulide

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Sources: KD Tripathi 7e·Verified: 2026-05-20 · House clinical team·Cockpit curated: 2026-05-20