Drug-induced liver disease: identification and management MCQs With Answer

Introduction: Drug-induced liver disease (DILI) is a critical topic for M.Pharm students, integrating pharmacology, toxicology and clinical decision-making. This quiz collection focuses on identification, classification, causality assessment and management strategies for DILI, including recognition of hepatocellular, cholestatic and mixed injury patterns, application of R-value and Hy’s law, use of RUCAM, and appropriate therapeutic responses such as drug withdrawal, antidotes, corticosteroids when indicated, and criteria for referral or transplant. Emphasis is placed on common offending agents, latency patterns, risk factors and prevention strategies. These practice MCQs are designed to deepen understanding and prepare students for clinical and regulatory roles concerning drug safety and hepatotoxicity.

Q1. Which of the following best defines an intrinsic (predictable) form of drug-induced liver injury?

• Idiosyncratic toxicity occurring unpredictably at therapeutic doses
• Dose-dependent hepatotoxicity with a predictable latency, such as acetaminophen overdose
• Immune-mediated liver injury appearing weeks to months after exposure
• Cholestatic injury caused by bile duct obstruction from drugs

Correct Answer: Dose-dependent hepatotoxicity with a predictable latency, such as acetaminophen overdose

Q2. The R-value used to classify patterns of liver injury is calculated how?

• (Total bilirubin / ULN) ÷ (ALT / ULN)
• (ALT / ULN) ÷ (ALP / ULN)
• (ALP / ULN) ÷ (ALT / ULN)
• (AST / ULN) ÷ (ALP / ULN)

Correct Answer: (ALT / ULN) ÷ (ALP / ULN)

Q3. An R-value of 6 indicates which predominant pattern of liver injury?

• Cholestatic
• Mixed
• Hepatocellular
• Unknown

Correct Answer: Hepatocellular

Q4. According to Hy’s law, which combination predicts a high risk of severe outcome in DILI?

• ALP >2×ULN and bilirubin >2×ULN without ALT elevation
• ALT or AST >3×ULN with total bilirubin >2×ULN in absence of cholestasis
• ALT >1.5×ULN and ALP >1.5×ULN
• Bilirubin >3×ULN regardless of transaminases

Correct Answer: ALT or AST >3×ULN with total bilirubin >2×ULN in absence of cholestasis

Q5. Which drug is classically associated with intrinsic, dose-related hepatotoxicity?

• Amoxicillin-clavulanate
• Acetaminophen (paracetamol)
• Isoniazid
• Flucloxacillin

Correct Answer: Acetaminophen (paracetamol)

Q6. Which antibiotic is a common cause of idiosyncratic cholestatic DILI and frequently reported in registries?

• Amoxicillin-clavulanate
• Ciprofloxacin
• Doxycycline
• Gentamicin

Correct Answer: Amoxicillin-clavulanate

Q7. The Roussel Uclaf Causality Assessment Method (RUCAM) is primarily used to:

• Quantify severity of liver failure for transplant listing
• Assess causality between a suspected drug and liver injury
• Determine antiviral therapy in viral hepatitis
• Calculate MELD score

Correct Answer: Assess causality between a suspected drug and liver injury

Q8. A patient on isoniazid develops ALT 200 U/L (ULN 40) and total bilirubin 1.0 mg/dL (ULN 1.2). What is the R-value and likely pattern?

• R = 1.6, cholestatic
• R = 5.0, hepatocellular
• R = 20.0, hepatocellular
• R = 0.2, cholestatic

Correct Answer: R = 5.0, hepatocellular

Q9. First-line management step when DILI is suspected in a patient taking a non-essential medication:

• Continue drug and monitor weekly
• Immediately stop the suspected offending medication
• Start steroids empirically
• Arrange urgent liver transplant

Correct Answer: Immediately stop the suspected offending medication

Q10. N-acetylcysteine (NAC) is the established antidote for which DILI scenario?

• Idiosyncratic antibiotic-induced cholestasis
• Acetaminophen overdose causing intrinsic hepatotoxicity
• Statin-induced transaminase elevation
• Herbal supplement–induced chronic hepatitis

Correct Answer: Acetaminophen overdose causing intrinsic hepatotoxicity

Q11. Which finding would most strongly suggest an immune-allergic mechanism of DILI?

• Rapid ALT rise within hours of first dose
• Eosinophilia, fever, rash and short latency after initiation
• Progressive cholestasis months after continuous dosing without systemic symptoms
• Isolated mild ALT elevation with no systemic signs

Correct Answer: Eosinophilia, fever, rash and short latency after initiation

Q12. In evaluation of suspected DILI, which investigation is most useful to exclude other causes and support diagnosis?

• Hepatitis serologies (A, B, C) and autoimmune markers
• Serum ceruloplasmin only
• Routine urine culture
• Fasting lipid profile

Correct Answer: Hepatitis serologies (A, B, C) and autoimmune markers

Q13. Which of the following is true regarding rechallenge with a suspected hepatotoxic drug?

• Rechallenge is safe for all drugs if initial injury was mild
• Rechallenge is contraindicated if initial injury met Hy’s law criteria or was severe
• Rechallenge is recommended to confirm diagnosis regardless of severity
• Rechallenge should be performed without monitoring

Correct Answer: Rechallenge is contraindicated if initial injury met Hy’s law criteria or was severe

Q14. Which herbal or dietary supplement class is increasingly implicated in DILI cases?

• Probiotics
• Bodybuilding supplements and herbal weight-loss products
• Oral multivitamins at recommended doses
• Dietary fiber supplements

Correct Answer: Bodybuilding supplements and herbal weight-loss products

Q15. A mixed pattern of liver injury is defined by an R-value that falls within which range?

• R ≤ 2
• R > 5
• R between 2 and 5 inclusive
• R = 0

Correct Answer: R between 2 and 5 inclusive

Q16. Which of the following statements about statin-associated liver enzyme elevations is most accurate?

• Statins frequently cause clinically significant liver failure and should be stopped in all elevations
• Mild asymptomatic transaminase elevations are common and often transient; continue statin with monitoring unless severe
• Statins always require immediate discontinuation if ALT rises above ULN
• Statin-induced liver injury is always cholestatic

Correct Answer: Mild asymptomatic transaminase elevations are common and often transient; continue statin with monitoring unless severe

Q17. Which prognostic score is commonly used to assess need for liver transplantation in acute liver failure from DILI?

• Child–Pugh score
• MELD score and King’s College criteria
• APACHE II score
• R-value

Correct Answer: MELD score and King’s College criteria

Q18. Which antitubercular drug is most commonly associated with hepatocellular DILI requiring monitoring?

• Ethambutol
• Rifampicin
• Isoniazid
• Streptomycin

Correct Answer: Isoniazid

Q19. In suspected severe DILI with signs of acute liver failure (encephalopathy, coagulopathy), the recommended immediate action is:

• Discontinue offending drug and refer urgently to a liver transplant center
• Restart the offending drug at a lower dose
• Wait and observe for one week
• Prescribe broad-spectrum antibiotics only

Correct Answer: Discontinue offending drug and refer urgently to a liver transplant center

Q20. Which monitoring strategy is appropriate when initiating a drug with known hepatotoxic potential (e.g., isoniazid) in an M.Pharm-managed medication plan?

• No baseline tests; test only if symptoms develop
• Baseline liver enzymes and periodic monitoring (e.g., monthly) with patient education on symptoms
• Empiric prescribing of hepatoprotective herbal remedies without testing
• Immediate liver biopsy before starting therapy

Correct Answer: Baseline liver enzymes and periodic monitoring (e.g., monthly) with patient education on symptoms

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