Adverse Drug Reaction


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Introduction of Adverse drug Effects for Undergraduate Students (MBBS)

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Adverse Drug Reaction

  1. 1. ADVERSE DRUG EFFECTS Dr Mayur A. Chaudhari Assistant Professor Department of Pharmacology Govt. Medical College, Surat. Available at
  2. 2. Objectives Definitions Types Pharmacovigilance Categories Some Photographs
  3. 3. Adverse Effect Undesirable/Unintended consequence Of Drug administration Adverse Effect.
  4. 4. Adverse Drug Reaction Any Noxious Change Suspected to be due to a drug At doses used therapeutically Requires treatment/ Decrease in dose Caution in the future use.
  5. 5. Adverse Event Untoward medical occurrence Does not necessarily have a causal relation with drug
  6. 6. Gum Hypertrophy
  7. 7. Classification Adverse effects Augmented Bizarre Chronic Delayed Ending of Use
  8. 8. Phocomelia
  9. 9. Pharmacovigilance Science and activities relating to Detection, Assessment Understanding Prevention Of Adverse Effects
  10. 10. Pharmacovigilance Post marketing Surveillance Drug alerts/ medical Alerts Changes in labeling Withdrawal of drugs
  11. 11. Prevention of ADE Avoid Unwanted drug use Appropriate dose, route, frequency Proper history Drug interactions Proper technique Lab monitoring
  12. 12. Side effects Unwanted unavoidable Pharmacodynamic effects At Therapeutic dose Atropine – Antisecretory – Premedication, Dryness Codeine – Constipation - Traveler's Diarrhoea, Cough
  13. 13. Secondary Effects Indirect Consequences of Primary action Suppression of bacterial flora by Antibiotics - Superinfection Depression of immunity by steroids – Activation of latent TB
  14. 14. Toxic effects Excessive Pharmacological Action Due to Overdose or Prolonged use Bleeding due to Heparin, AV Block by Digoxin POISONING Resuscitation and maintenance of Vitals Termination of exposure Prevention of absorption Hastening elimination
  15. 15. Intolerance Toxic effect at Therapeutic dose Low Threshold to the action of drug Triflupromazine – Muscular Dystonia Carbamazepine – Ataxia Chloroquine – Vomiting, Abdominal Pain
  16. 16. Idiosyncrasy Genetically Determined abnormal reactivity to drug Barbiturate – Excitement and Mental Confusion Chloramphenicol – Aplastic Anaemia
  17. 17. Drug Allergy Immunologically mediated reaction Stereotype symptoms unrelated to Pharmacodynamic action Much smaller doses of drug Different time course of action.
  18. 18. Features of Drug Allergy Unrelated to pharmacodynamic actions Similar to food/ Protein allergy, Poor correlation with dose Only in few individuals Prior Sensitization needed Positive Dechallnge and rechallenge
  19. 19. Types I - Anaphylactic II - Cytolytic III – Arthus Reaction IV – Delayed Hypersensitivity
  20. 20. Allergy
  21. 21. Clinical Manifestations Urticarial Rashes and Angioedema (Type I, III) Nonurticarial Rashes (Type I, II, IV) Anaphylactic Shock (Type I) Asthma (Type I) Serum Sickness (Type III) Thrombocytopenia (Type II)
  22. 22. Photosensitivity Drug induced sensitization of the skin to UV Radiation Phototoxic Photoallergic
  23. 23. Drug Dependence Psychological Dependence Physical dependence Drug Abuse Drug addiction Drug habituation
  24. 24. Withdrawal reaction Sudden interruption of therapy results in adverse consequences Worsening of clinical condition ↑ Seizure frequency – Antiepileptic drug Hypertension - Clonidine
  25. 25. Teratogenicity Capacity of drug To cause Foetal abnormality When given to pregnant woman
  26. 26. Fertilization and implantation Organogenesis Growth and Development
  27. 27. Spina Bifida
  28. 28. Cleft Lip/ Cleft Palate
  29. 29. Teeth Staining by Tetracycline
  30. 30. Mutagenicity Capacity of drug to cause genetic defects
  31. 31. Carcinogenicity Capacity of drug to cause cancer
  32. 32. Drug Induced Diseases Iatrogenic / Physician Induced Peptic ulcer by Aspirin Hepatitis by isoniazid DLE by hydralazine
  33. 33. Thanks for Attention