Sulindac

CLINORIL

Open Sulindac in the interactive console ↗

What it isCOX-inhibiting NSAID prodrug converted to an active sulfide; arthritis and acute gout.

Why this oneIts unusual off-label niche is suppressing colorectal polyps in familial adenomatous polyposis.

What limits itHepatotoxicity and severe skin reactions are unusually prominent; cardiovascular and GI risks remain.

FDA-approved for

arthritis (~1978)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING NSAID class: serious CV thrombotic events (MI, stroke), contraindicated peri-CABG; serious GI bleeding/ulceration/perforation.

FDA dosing	Population	Start	Target	Max
Osteoarthritis / rheumatoid arthritis / ankylosing spondylitis	Adults	150 mg BID	150 mg BID	400 mg/day
Acute painful shoulder (subacromial bursitis/supraspinatus tendinitis) / acute gouty arthritis	Adults	200 mg BID	200 mg BID	400 mg/day

Renal Undefined

Hepatic Undefined

Doses above 400 mg/day not recommended

Instructions

Take with food
Use lowest effective dose for shortest duration
Acute painful shoulder: usually 7-14 days; acute gouty arthritis: usually 7 days

Contraindications

Coronary artery bypass graft (CABG) surgery setting
Aspirin/NSAID-induced asthma, urticaria, or allergic-type reactions

Cautions

CV thrombotic events (MI, stroke) — use shortest duration; avoid peri-CABG
GI bleeding, ulceration, perforation — can occur without warning; elderly at higher risk
Hepatotoxicity; hypertension; heart failure/edema; renal effects
Anaphylactic/anaphylactoid reactions; serious skin reactions

Adverse reactions

GI pain
Dyspepsia
Nausea/vomiting
Diarrhea
Constipation
Flatulence
Rash
Pruritus
Dizziness
Headache
Edema
Tinnitus

Pregnancy Avoid at ≈30 weeks gestation and later (premature ductus arteriosus closure); limit use 20-30 weeks (fetal renal dysfunction/oligohydramnios)

Lactation Undefined

⚠ BOXED WARNINGS

Cardiovascular thrombotic events
Gastrointestinal bleeding, ulceration and perforation

Cost, est. cash$5–$150/month

Generic entry1990

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger3 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryMultiple / indication-, trimester- or formulation-dependent

Defining liabilityGI bleeding, kidney injury, hypertension and fluid retention; many agents increase lithium concentrations.

Active metabolites

Sulindac sulfide

Mechanism of action: Sulindac ballicule

Sulindac ballicule: receptor binding, kinetics and half-life diagram

Open Sulindac in the interactive console ↗

Memory aids: mascots and interaction avatars

Sulindac CLINORIL mascot mnemonic cartoon — **“Sully’s Clinical role”**
“The N said... NSAID”

Box: minimal PK interactions

Open Sulindac in the interactive console ↗