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Adverse Drug Reaction (ADR) is any response to a drug which is noxious (harmful or deadly) and
unintended and which occurs at dose used by man for prophylaxis, diagnosis, or therapy.
In the past century, great advances have been made to discover, test, and market medications that
cure diseases and alleviate suffering. All drugs have the potential to cause harm in susceptible
individuals. All who manufacture, prescribe, dispense, regulate, and use drugs have a responsibility to
assure their proper use and reduce possibility of drug-induced disease.
Pharmacists stand at the crossroads of therapy, where they have the responsibility of providing
professional services to patients receiving drugs prescribed by physicians and also to patients selfmedicating with non-prescription drugs.
Pharmacists will be called upon to take a more active role in educating the public concerning safe and
effective use of medications. These new responsibilities probably will be carried out through
increased verbal communication as well as written material which will be aided by the computer.
1. Problems related to the primary action of the drug
Ex. Antihypertensive may cause abrupt or rapid lowering of blood pressure so that the patient may
suffer very low blood pressure and cause symptoms of fainting
2. Problems not related to the primary action of the drug.
Ex. Aspirin is analgesic/ antipyretic but has the property of irritating the walls of the stomach and
may produce ulceration and bleeding in the stomach.
3. Hypersensitivity or Allergy – generally not related to the dose of drug administered.
A. Drug Factors
1. Dose and Duration of Treatment
- The bigger the dose and the longer the treatment, the greater the possibility of adverse
drug reaction.
2. Inherent Toxicity of the Drug
- Drugs with multiple pharmacological effects are prone to produce adverse reactions.
Ex. Amphotericin B is a very toxic drug which produces ADR such as chills, fever, and nausea
in up to 75% of patients receiving it but it is a systematic anti-fungal with widest spectrum.
3. Multiple Drug Therapy
- ADR increases with the number of drug administered to a patient

4. and severity. or slowly after discontinuance of the medication or may occur in patients who have previously used the medication without difficulty A. diseases of the kidney that lead to renal failure. Common sites are dorsal surface of hands and feet.  Nausea & vomiting – potassium chloride. Poor Patient Compliance . distribution. etc. Blood Group . Toxic epidermal necrosis – rare but sometimes fatal. Age . Pathological changes in the body may cause organs to be more sensitive to the pharmacologic action of the drug. color. E. Photosensitivity – abnormal and severe reaction of the skin to sunlight 1) Phototoxic – resembles severe sunburn 2) Photoallergic – usually eczematous. preservative. 5. extent. purpuic (skin rashes resulting from bleeding into the skin from small blood vessels) 2.Women are prone to ADR than men 3. Most reactions involve:  Anorexia (loss of appetite). Formulation of the Drug .This may result due to excessive dose of the drug or use beyond a reasonable period of time TYPES OF ADVERSE DRUG REACTIONS 1. Exfoliative dermatitis – reddening of the skin followed by scaling and sloughing. Erythema multiforme macules (resembling freckles) and papules (resembling chicken pox). and excretion. forearms. They may occur in gradual onset. Hepatic Reaction – liver damage 3. bullous (blister with liquid).Disease can alter the normal functions of the body. appearance of scalded skin D. Dermatologic Reactions – may vary in site. Concurrent Diseases . Rashes resembling measles or urticarial (itchy wheals) eruptions B. C. INH.Heredity predisposes individuals to increased toxicity to drugs such as Succinyl Choline. flavor.Women of blood type A are more likely to develop thromboembolism (clot in the vein while in oral contraceptive than women of blood type O) 6. coating.Drugs with the same active ingredient may vary in their effect due to the excipient. B. and Monoamine Oxidase inhibitors 4. disappear rapidly. The most severe form can result to cardiac failure and death. Dreaded illnesses such as liver cirrhosis. Hirsutism – excessive hair growth F. and trunk. magnesium hydroxide . Route of Administration . Host (Patient) Factor 1. Sex . urticarial (red and wheals). and digestive tract diseases may affect drug absorption.Intravenous routes produces more ADR compared with the oral or IM routes 5. aluminum hydroxide.Infants and elderly suffer higher incidence of ADR 2. Gastrointestinal Reactions Most medications are taken orally and concentration of medication is highest in the gastrointestinal tract. metabolism. Heredity .

Cough. and prolonged bleeding after injury) can result from bone marrow suppression and platelet destruction D.Lincomycin. Acute renal ischemia c. Indomethacin and cytostatic drugs B. lithium carbonate. Primaquine.    Constipation and/or diarrhea Gastrointestinal hemorrhage – corticosteroids Pancreatitis Dysgeusia (altered taste sensation) – penicillins. levodopa. Amikacin. Sulfonamide. and Ibuprofen. decreased corneal sensitivity d. Nitrofurantoin. 5. Clindamycin. Gentamycin. Interstitial alveolitis and pneumonitis d. Aminoglycoside. Acute renal failure b.They may result from direct or indirect action such as allergic reaction that cause bronchoconstriction or cardiac depressants that induce pulmonary edema and direct toxic actions that cause pulmonary fibrosis (thickening or scarring of tissue) a. Tinnitus (ringing or buzzing) in the ears can be caused by NSAIDs (Indomethacin. Cochlear Toxicity – results in hearing loss Permanent hearing loss can be caused by Streptomycin. Oxyphenbutazone. Aspirin. Decreased tear production b. Corneal deposit e. Dyspnea – difficult breathing e. Naproxen. corneal sensitivity c. sclerosis. metronidazole. Pulmonary Reactions . and Ibuprofen). Naproxen. Hemolysis (destruction of blood cells) can be brought about by. Pulmonary fibrosis c. Acute interstitial nephritis d. interstitial inflammation 8. Isosorbide Dinitrate. Ethacrynic Acid. Aplastic Anemia – causative drugs are Chloramphenicol. Hematologic Reactions A. Blurred vision f. Elevated intraocular pressure g. Polyuria – production of large volume of urine . salicylates as Aspirin. Ototoxicity . Phenacetin. Renal Reactions (effects on the kidney) a. Temporary hearing loss can be caused by Indomethacin. dyspnea. and Quinidine. Netilmicin. spontaneous bruising. captopril  Dyspepsia and ulceration of gastric mucosa – NSAIDs  Colitis (inflammation of the colon). chest pain. Antibiotics. Vestibular Toxicity – results in dizziness or vertigo B. Optic neuropathy 7. Broncho-constriction and asthma b. Ocular Toxicity a. Quinine. Drug-induced agranulocytosis (severe acute deficiency of certain blood cells as a result of damage to bone marrow) C. fibrosis. Thrombocytopenia (reduction in the number of platelets in the blood resulting to bleeding into the skin. 6.can be manifested in two ways depending in the portion of the inner ear affected as follows: A. Chloramphenicol 4. Phenylbutazone. Whitening of lashes. Retinal damage. Methyldopa.

For a drug to induce teratogenic effects. it must be given from day 12 to 56. Teratogenic Effects – are developmental abnormalities in the fetus. period of organogenesis (development of the organs) Thalidomide (1960) caused teratogenic effects on 30% . The drug caused phocomelia (absence or deformity of limbs) Retinoids and ACE inhibitors (angiotension converting enzyme inhibitor) have shown potential to induce birth defects 10. Polydipsia – abnormal increase of thirst 9. Carcinogenic Effects – causes mutagenic transformation leading to production of cancer cells .e.40% of mothers who took the drug during organogenesis period.