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Tools Health & LongevityFDA Drug Safety Explorer

openFDA & FAERS Post-Market Pharmacovigilance Active

FDA Drug Safety & Boxed Warning Explorer

Search 50,000+ FDA-approved medications (including Zerodol-P, Paracetamol, Ibuprofen, Ozempic, Metformin, Adderall, and Statins). View official Black Box Warnings, FAERS adverse reaction incidence rates, contraindications, and laboratory monitoring protocols.

Zerodol-P / Aceclo-Plus

Generic: Aceclofenac 100mg + Paracetamol 325mg

Drug Class: Non-Steroidal Anti-Inflammatory Drug (NSAID) + Non-Opioid Analgesic

WHO-EML / National Formulary Combination

Boxed Warning Present

Official FDA Boxed Warning

WARNING: HEPATOTOXICITY & GASTROINTESTINAL / CARDIOVASCULAR RISK. Paracetamol/Acetaminophen can cause acute liver failure exceeding 4,000 mg/day or when combined with alcohol. Aceclofenac increases the risk of serious gastrointestinal adverse events including ulceration, bleeding, and perforation of the stomach or intestines.

FAERS & Clinical Trial Adverse Event Incidence (%)

Reports: 54,200

Dyspepsia / Abdominal Discomfort

Mild18%

Nausea & Vomiting

Mild12%

Dizziness & Lightheadedness

Mild8%

Elevated Hepatic Transaminases (ALT/AST)

Moderate4.5%

Gastrointestinal Bleeding / Peptic Ulcer

Severe2.1%

Renal Impairment / Elevated Serum Creatinine

Severe1.5%

Absolute & Relative Contraindications

•Active peptic ulcer disease or history of recurrent GI bleeding
•Severe hepatic impairment (cirrhosis or acute hepatitis)
•Severe renal failure (eGFR < 30 mL/min)
•Third trimester of pregnancy (premature closure of ductus arteriosus)
•Aspirin-exacerbated respiratory disease (aspirin triad)

Required Clinical & Laboratory Monitoring

Liver function tests (ALT, AST, Bilirubin) for extended therapy > 14 days

Renal function (Serum Creatinine and BUN) in elderly or hypertensive patients

Stool occult blood and hemoglobin if long-term analgesic use is necessary

Strict enforcement: Max 4,000 mg total daily paracetamol from ALL combined sources

View Full FDA Package Insert on DailyMed / AccessData

Pharmacovigilance Telemetry

Total FAERS Adverse Reports

54,200

Serious Outcome Proportion

19%

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Pharmacovigilance & Clinical Safety Notice:Information is synthesized from openFDA structured product labeling, FAERS quarterly data, and clinical pharmacology monographs. FAERS reports represent spontaneous post-marketing submissions and do not establish direct causality. Never discontinue or adjust prescription dosages without consulting a licensed physician.