Management of adverse drug reactions MCQs With Answer

Management of adverse drug reactions (ADR) is a core topic for B.Pharm students, covering identification, prevention, reporting, and treatment of harmful drug effects. This introduction emphasizes pharmacovigilance, causality assessment (Naranjo, WHO‑UMC), severity assessment, risk minimization, and practical management steps such as drug withdrawal, supportive care, antidotes, and dose adjustment in renal or hepatic impairment. Key concepts include ADR classification (Type A–F), pharmacogenomics, drug interactions, monitoring strategies, and regulatory reporting of suspected ADRs. Understanding these topics helps pharmacists ensure patient safety, reduce morbidity, and contribute to effective signal detection. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which ADR type is dose-dependent, predictable, and related to the known pharmacology of the drug?

• Type A (Augmented)
• Type B (Bizarre)
• Type C (Chronic)
• Type D (Delayed)

Correct Answer: Type A (Augmented)

Q2. The first-line immediate management for anaphylaxis caused by a drug is:

• High‑dose intravenous corticosteroids
• Intramuscular epinephrine
• Oral antihistamine
• Subcutaneous insulin

Correct Answer: Intramuscular epinephrine

Q3. Which causality assessment tool is commonly used for standardized ADR assessment and yields categories like ‘definite’, ‘probable’, and ‘possible’?

• Hartwig Severity Scale
• Naranjo Algorithm
• Beers Criteria
• Glasgow Coma Scale

Correct Answer: Naranjo Algorithm

Q4. In the management of suspected serious ADR, the most appropriate initial step is:

• Immediate rechallenge with the suspected drug
• Continue drug and observe for 48 hours
• Stop the suspected offending drug
• Switch to a drug in the same class without assessment

Correct Answer: Stop the suspected offending drug

Q5. Which monitoring parameter is most important when managing a patient on long‑term methotrexate therapy to detect ADRs early?

• Serum amylase
• Complete blood count and liver function tests
• Pulmonary function testing daily
• Serum creatine kinase only

Correct Answer: Complete blood count and liver function tests

Q6. A severe cutaneous adverse reaction presenting with mucosal involvement and epidermal detachment is most consistent with:

• Urticaria
• Stevens‑Johnson syndrome / Toxic epidermal necrolysis (SJS/TEN)
• Fixed drug eruption
• Drug-induced acne

Correct Answer: Stevens‑Johnson syndrome / Toxic epidermal necrolysis (SJS/TEN)

Q7. Which of the following is an antidote used in management of paracetamol (acetaminophen) overdose?

• Flumazenil
• N‑acetylcysteine
• Atropine
• Vitamin K

Correct Answer: N‑acetylcysteine

Q8. Which pharmacogenomic marker is associated with a high risk of hypersensitivity to abacavir?

• CYP2D6 poor metabolizer status
• HLA‑B*57:01 allele
• VKORC1 polymorphism
• HLA‑DR4 allele

Correct Answer: HLA‑B*57:01 allele

Q9. The WHO‑UMC system is used primarily for:

• Severity grading of ADRs for clinical trials
• Causality assessment of suspected adverse drug reactions
• Calculating drug doses in renal failure
• Laboratory reference ranges

Correct Answer: Causality assessment of suspected adverse drug reactions

Q10. Which action is contraindicated after a severe immunologic ADR such as SJS/TEN?

• Permanently avoid the suspected causal drug
• Perform immediate desensitization without specialist input
• Report the reaction to the pharmacovigilance center
• Provide supportive care and dermatology consultation

Correct Answer: Perform immediate desensitization without specialist input

Q11. The Hartwig and Siegel scale is used to assess:

• Drug‑drug interaction severity
• Causality of ADRs
• Clinical severity (mild, moderate, severe) of ADRs
• Pharmacokinetic parameters

Correct Answer: Clinical severity (mild, moderate, severe) of ADRs

Q12. Which is the best method to reduce ADR risk in elderly patients on multiple medications?

• Increase all doses to achieve efficacy quickly
• Medication review to reduce polypharmacy
• Stop monitoring because ADRs are unavoidable
• Prescribe only over‑the‑counter drugs

Correct Answer: Medication review to reduce polypharmacy

Q13. Reporting a suspected ADR to a national pharmacovigilance program typically requires submitting which type of document?

• Individual Case Safety Report (ICSR)
• Randomized controlled trial protocol
• Patient consent form only
• Marketing authorization application

Correct Answer: Individual Case Safety Report (ICSR)

Q14. In a patient with warfarin toxicity, which laboratory test is most useful to guide management?

• Serum creatinine
• International Normalized Ratio (INR)
• Serum bilirubin
• Fasting blood glucose

Correct Answer: International Normalized Ratio (INR)

Q15. Which preventive strategy is appropriate to avoid drug‑induced QT prolongation?

• Co‑prescribe two QT‑prolonging drugs routinely
• Screen for electrolyte abnormalities and avoid interacting drugs
• Avoid ECG monitoring altogether
• Prescribe at maximum dose regardless of risk

Correct Answer: Screen for electrolyte abnormalities and avoid interacting drugs

Q16. Rechallenge with a drug after a mild, non‑life‑threatening ADR may be considered when:

• The reaction was severe and life‑threatening
• The suspected drug is essential, benefits outweigh risks, and done under supervision
• No documentation or consent is obtained
• There is a safer alternative available

Correct Answer: The suspected drug is essential, benefits outweigh risks, and done under supervision

Q17. Which of the following best describes a ‘signal’ in pharmacovigilance?

• Confirmed causal relationship between a drug and an adverse event
• Information that suggests a new causal association or new aspect of a known association
• A routine lab result within normal limits
• A marketing promotion for a drug

Correct Answer: Information that suggests a new causal association or new aspect of a known association

Q18. Activated charcoal is most useful for management of oral drug overdose when administered:

• Within minutes to a few hours after ingestion, depending on the drug
• Only after 48 hours
• Never, it is ineffective for all drugs
• Only for drugs that are water soluble

Correct Answer: Within minutes to a few hours after ingestion, depending on the drug

Q19. Which drug interaction mechanism commonly increases plasma levels of a substrate drug leading to ADRs?

• Induction of hepatic CYP450 enzymes
• Inhibition of hepatic CYP450 enzymes
• Increased renal clearance of the substrate
• Reduced gastrointestinal absorption of the substrate

Correct Answer: Inhibition of hepatic CYP450 enzymes

Q20. For immunologic drug allergies, a useful prevention strategy before starting therapy is:

• Ignore patient allergy history since most are irrelevant
• Obtain detailed allergy history and perform allergy testing when indicated
• Always prescribe the newest drug available
• Administer drug without monitoring in all cases

Correct Answer: Obtain detailed allergy history and perform allergy testing when indicated

Q21. Which of the following is a typical feature of Type A ADRs?

• Idiosyncratic immune mechanism
• Unpredictable and unrelated to dose
• Related to pharmacological action and dose‑dependent
• Always requires desensitization

Correct Answer: Related to pharmacological action and dose‑dependent

Q22. A patient develops severe neutropenia after starting clozapine. The correct management includes:

• Continue clozapine and monitor weekly
• Immediate discontinuation of clozapine and hematology referral
• Double the dose to overcome the effect
• Switch to another antipsychotic without monitoring

Correct Answer: Immediate discontinuation of clozapine and hematology referral

Q23. Which regulatory action indicates the highest level of concern for drug safety communicated to prescribers?

• Routine informational leaflet
• Black box (boxed) warning
• General marketing authorization
• Over‑the‑counter switch

Correct Answer: Black box (boxed) warning

Q24. In hepatic impairment, which management approach helps reduce ADR risk for hepatically cleared drugs?

• Maintain standard dose regardless of liver function
• Reduce dose or increase dosing interval based on hepatic function
• Discontinue monitoring of liver enzymes
• Increase dose opportunistically

Correct Answer: Reduce dose or increase dosing interval based on hepatic function

Q25. Which ADR reporting characteristic is most useful for signal detection at a national pharmacovigilance center?

• High‑quality, well‑documented individual case reports
• Anonymous one‑line comments without details
• Only positive, benefit‑focused reports
• Internal memos not shared with authorities

Correct Answer: High‑quality, well‑documented individual case reports

Q26. Desensitization procedures are primarily indicated for:

• Severe SJS/TEN reactions
• Essential drug allergy where no alternatives exist and reaction is IgE‑mediated, performed under supervision
• All idiosyncratic, dose‑dependent reactions
• Routine prevention of drug interactions

Correct Answer: Essential drug allergy where no alternatives exist and reaction is IgE‑mediated, performed under supervision

Q27. Which laboratory test should be monitored in patients on long‑term amiodarone therapy to detect ADRs?

• Thyroid function tests and liver function tests
• Urine dipstick only
• Serum amylase daily
• Fasting lipid profile weekly

Correct Answer: Thyroid function tests and liver function tests

Q28. If a patient develops torsades de pointes due to a drug, the immediate management includes:

• Oral beta‑blocker administration
• Intravenous magnesium sulfate and removal of offending drug
• Continue the drug and observe
• Give high‑dose vitamin D

Correct Answer: Intravenous magnesium sulfate and removal of offending drug

Q29. Which factor increases the likelihood of an ADR due to accumulation of renally cleared drugs?

• Young age with normal renal function
• Renal impairment reducing drug clearance
• Enhanced hepatic metabolism
• Use of non‑renal elimination pathways

Correct Answer: Renal impairment reducing drug clearance

Q30. Patient counseling to minimize ADR risks should include which key point?

• Stop all medications when feeling unwell without consulting
• Report any new or unusual symptoms promptly and follow monitoring advice
• Ignore drug‑drug interaction warnings
• Never inform healthcare providers about herbal supplements

Correct Answer: Report any new or unusual symptoms promptly and follow monitoring advice

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