1. ADVERSE DRUG REACTION
Dr. Syed Ayaz Ali M.Pharm; Ph.D Associate Professor & Head Dept. of Pharmacology Y.B.Chavan College of Pharmacy Aurangabad

2. ADVERSE DRUG REACTIONS
Drug Administered
Undesired Effects
Desired Effects
Clinically beneficial action
Innocuous (Not Harmful)
Harmful Or ADR or Untoward reaction

3. Factors Responsible for ADR’s
Drug Explosion- Potent drugs- ADR is appreciable
Physician – drug induced diseases (Iatrogenic diseases)
Increased availability of potent drugs
Dangerous drugs without prescription
Environmental & Occupational exposure of Chemicals, drugs to Humans
Polypharmacy
Self medication
Side effect: It is restricted to therapeutically undesirable but unavoidable effects of drugs , even when they are used in their therapeutic doses.
Examples: Anorexia, Cramps, Mild diarrhea, headache, nausea etc.

4. Adverse drug reactions can be logically separated into two types.
Adverse drug reactions : An adverse drug reaction is any response to a drug which is noxious (injurious) and unintended and which occurs at doses used in man for prophylaxis, diagnosis or therapy of disease. Major Adverse drug reactions can involve many organs and include addiction, allergic reactions, shock, CHF, Paralysis, coma, convulsions, diabetes mellitus, neoplasia, anaphylactic shock etc. ADR’s require treatment or decrease in dosage or stoppage of therapy.
Adverse drug reactions can be logically separated into two types.

5. Type A ADR’s Type B ADR’s
Normal Totally Abnormal
Augmented Pharmacological actions 2. Not expected
In Therapeutic doses 3. In Therapeutic doses
E.g. Bradycardia with Beta blockers 4.E.g. Malignant hyperthermia of anesthetic & Immune reactions.
Predictable 5.Unpredictable
Dose dependent 6. Not observed during conventional toxicological screening.
Incidence & morbidity is high 7.Incidence & morbidity is low
Mortality is low 8.Mortality is high.

6. Classification of ADR’s Adverse drug reactions may be classified as under 1. Pharmacologic ADR’s A. Extension of therapeutic effect B. Nontherapeutic adverse effect 2. Non Pharmacologic ADR’s A. Hypersensitivity (Drug Allergy) B. Idiosyncrasy (Pharmacogenetics) C. Photosensitivity 3. Disease related ADR’s 4. Multiple Drug Reactions 5. Miscellaneous ADR’s A. Carcinogenicity B. Teratogenicity (Dysmorphogenesis) C. Drug Dependence D. Overdosage (Relative & Absolute) E. Drug-induced sexual dysfunctions

7. Drugs acting on Cholinergic Nervous System
Category
Class
Prominent ADR’s
Parasympathomimetics
Cholinomimetic Choline esters
Generalized cholinergic stimulation, sweating, salivation, flushing, fall in B.P, abdominal pain, diarrhea, bronchospasm
Natural alkaloids
CNS disturbances, profuse sweating & salivation
Anticholinestrase (Reversible) Physostigmine
Convulsions, bradycardia, paralysis of skeletal muscles
Neostigmine
Parasympatholytics
Atropine
Xerostomia, hallucination, delirium, dryness of mouth, dry skim, increase in body temp, blurred vision, photophobia, urinary retention, palpitation & tachycardia and constipation.