Drug reference directory
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 only30AVOIDAvoid≥90

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
30minONSET2hPEAK3.5ht½7hDURATION
ONSET
30min · absorption
PEAK
2h · Tmax
t½
3.5h · t½
DURATION
7h · per dose
EXCRETION
Renal — mainly metabolites
route + CYP
INTERACTIONS
3 major
SEVERE in our sources
PREGNANCY
Avoid; 3rd trimester contraindicated.
FDA category + note
Top interactionssee all 5 →
  • LithiumSevereDatabaseKimi deep-research + Cla
  • AnticoagulantsSevereDatabaseKimi deep-research + Cla
  • Other Hepatotoxic DrugsSevereDatabaseKimi deep-research + Cla

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

Ace Inhibitors
Moderate
Database

Triple-whammy AKI

Monitor renal function

Source: Kimi deep-research + Cla

Corticosteroids
Moderate
Database

Additive GI ulceration

Gastroprotection

Source: Kimi deep-research + Cla

7 additional unreviewed or low-confidence interactions hidden because their provenance or source detail is insufficient.

Related guidelines

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Textbook-sourced·Sources: KD Tripathi 7e·Updated: 2026-05-20·Cockpit curated: 2026-05-20

Nimesulide Drug Reference · House