ADVERSE EFFECTS

❖ Predictable or unpredictable
➢ Excessive pharmacologic effects
➢ Most predictable and are often the easiest to prevent
or counteract
➢ May be unpleasant or even dangerous
❖ Occur for many reasons, including the following:
➢ The drug may have other effects on the body besides
the therapeutic effects
➢ The patient is sensitive to the drug given
➢ The drug’s action on the body causes other
responses that are undesirable or unpleasant
➢ The patient is taking too much or too little of the
drug, leading to adverse effects
❖ Primary actions
➢ One of the most common occurences in drug therapy
is the development of adverse effects from simple
overdose
➢ It can be extensions of the desired effect.
❖ Secondary actions of the drug are effects that the drug
causes in the body that are not related to the therapeutic
effect side effects
➢ In addition to the desired pharmacological effect

HYPERSENSITIVITY
❖ Some patients are excessively responsive to either the
primary or the secondary effects of a drug
❖ It may result from a pathological or underlying condition
❖ Hypersensitive Reactions → Fell and Coombs Classification
System
➢ Type I reactions are immediate hypersensitivity
reactions that are mediated by immunoglobulin E
(IgE) antibodies. mediating allergic reactions
■ Eg: urticaria (hives), atopic dermatitis,
anaphylactic shock
cyto-, hemo-, erythema- dissolution or disruption of cells

➢ Type II reactions are cytolytic reactions that involve

complement are mediated by immunoglobulins G and
M (IgG and IgM) neutralize toxic substances, support phagocytosis, and destroy invading
microorganisms
■ Eg: hemolytic anemia, thrombocytopenia, and
drug-induced lupus erythematosus
➢ Type III reactions are mediated by immune complexes.
The deposition of antigen-antibody complexes in
vascular endothelium leads to inflammation,
lymphadenopathy, and fever (serum sickness)
swollen lymph nodes ■ Eg: severe skin rash seen in patients with a

life-threatening form of drug-induced immune

vasculitis that is known as Stevens-Johnson
syndrome
➢ Type IV reactions are delayed hypersensitivity
reactions that are mediated by sensitized
lymphocytes.
■ Eg. ampicillin-induced skin rash that occurs in
patients with viral mononucleosis
DRUG ALLERGY
Occurs when the body forms antibodies to a particular
drug, causing an immune response when the person is
re-exposed to the drug.
Four main classifications:
a. Anaphylactic reaction – this allergy involves an
antibody that reacts with specific sites in the body to
cause the release of chemicals, including histamine
that produce immediate reactions (mucous
membrane swelling & constricting bronchi) that can
lead to respiratory distress and even respiratory
arrest
b. Cytotoxic reaction – this allergy involves antibodies
that circulate in the blood and attack antigens (the
drug) on cell sites, causing death of that cell. This
reaction is not immediate but may be seen over a few
days.
 c. Serum Sickness reaction – this allergy involves
antibodies that circulate in the blood and cause
damage to various tissues by depositing in blood
vessels. This reaction may occur up to 1 week or more
after exposure to the drug.
d. Delayed allergic reaction – this reaction occurs
several hours after exposure and involves antibodies
that are bound to specific white blood cells.

DRUG-INDUCED TISSUE AND ORGAN DAMAGE

❖ DERMATOLOGICAL REACTION
➢ They adverse reactions involving the skin
➢ It range from a simple rash to potentially fatal
exfoliative dermatitis
■ Rashes, Hives
➢ Rash, scaling, fever, enlarged lymph nodes, enlarged
liver and the potentially fatal erythema multiforme
exudativum or known as Stevens-Johnson syndrome.
➢ INTERVENTION
■ In mild cases, or when the benefit of the drug
outweighs the discomfort of the skin lesion,
provide frequent skin care; instruct the patient
to avoid rubbing, wearing tight or rough
clothing, and using harsh soap, or perfumed
lotions
■ Administer anti-histamines as needed
■ In sever cases, discontinue the drug
■ Notify the prescriber
■ Application of topical corticosteroids or
emollient are frequently used

STOMATITIS
❖ Inflammation of the mucous membranes, can occur
because of a direct toxic reaction to the drug or because
 the drug deposits in the end capillaries in the mucous
membranes, leading to inflammation.
❖ Eg: Antineoplastic drugs
➢ ASSESSMENT
■ It includes swollen gums, inflamed gums
(gingivitis) and swollen and red tongue (glossitis)
➢ INTERVENTIONS
■ Provide frequent mouth care with a non irritating
solution
■ Offer nutrition evaluation
■ Development of tolerated diet

SUPERINFECTION
❖ One of the body’s protective mechanisms is provided by
the wide variety of bacteria that live within or on the
surface of the body.
❖ This bacterial growth is called the normal flora
❖ Several kinds of drugs especially antibiotics destroy the
normal flora, leading to development of superinfection
➢ ASSESSMENT
■ Symptoms can include fever, diarrhea, black or
hairy tongue, inflamed and swollen tongue
(glossitis), mucous membrane lesions and
vaginal discharge with or without itching
➢ INTERVENTIONS
■ Provide supportive measures like frequent mouth
care, skin care, access to bathroom, small and
frequent meals
■ Administer antifungal therapy as appropriate

BLOOD DYSCRASIA
❖ It is bone marrow suppression caused by drug effects
➢ ASSESSMENT
■ Fever, chill, sore throat, weakness, back pain,
dark urine, agranulocytosis, anemia,
 thrombocytopenia (low platelet), leukopenia (low
WBC) or a combination of these (pancytopenia)
■ Most serious is aplastic anemia
➢ INTERVENTION
■ Monitor blood counts
■ Provide supportive measures (rest, protection
from exposure to infection, injury, or bleeding)
■ In severe cases, discontinue the drug or stop
administration until the bone marrow recovers to
safe level, but may have serious consequences
before toxicity can be detected

TOXICITY
❖ Introducing chemical into the body can sometimes affect
the body in a very noxious or toxic way

LIVER INJURY (HEPATOTOXICITY)

❖ Cholestatic hepatotoxicity is often caused by a
hypersensitivity mechanism producing inflammation and
stasis of the biliary system.
❖ Hepatocellular toxicity is sometimes caused by a toxic
drug metabolite.
➢ ASSESSMENT
■ Fever, malaise, nausea, and vomiting, jaundice,
change in color of urine or stools, abdominal
pain or colic, elevated liver enzymes (serum
transaminase level)
➢ INTERVENTIONS
■ Discontinue the drug and notify the prescriber
■ Offer supportive measures (small, frequent,
meals, skin care, cool environment, rest periods)

RENAL INJURY (NEPHROTOXICITY)

 ❖ Classified according to site and mechanism and include
interstitial nephritis, renal tubular necrosis and
crystalluria (the precipitation of insoluble drug in the
renal tubules)

BLADDER TOXICITY
❖ It is less common than renal toxicity, but it may occur as
an adverse effect of a few drugs.
❖ One example is cyclophosphanamide, an antineoplastic
drug whose metabolite causes hemorrhagic cystitis.
➢ ASSESSMENT
■ Elevated blood urea nitrogen (BUN), elevated
creatinine concentration, decreased hematocrit,
electrolyte imbalances, fatigue, malaise, edema,
irritability, and skin rash
➢ INTERVENTIONS
■ Notify the prescriber
■ Discontinue the drug as needed
■ Offer supportive measures (diet & fluid
restrictions, skin care, electrolyte therapy, rest)
■ In severe cases, dialysis may be required for
survival

OTHER ORGAN TOXICITIES

❖ Pulmonary toxicity occurs through a variety of
mechanisms. Some drugs cause respiratory depression via
their effects on the brain stem respiratory centers.
❖ Relatively few drugs produce cardiotoxicity. Some may
cause skeletal muscle damage evidenced by muscle pain
and sometimes leading to rhabdomyolysis.

POISONING
❖ Occurs when an overdose of a drug damages multiply
body systems, leading to the potential for fatal reactions.
 ❖ Emergency and life support measures often are needed in
severe cases

SKIN RASHES OF ALL VARIETIES

❖ These can range from a simple rash to potentially fatal
exfoliative dermatitis. Adverse reactions involve the skin
because many drugs can deposit there or cause direct
irritation to the tissue. Reactions
❖ It includes macular, papular, maculopapular & urticarial
rashes, and potentially fatal erythema multiforme
exudativum (Stevens-Johnson syndrome) may be produced
by drug hypesensitivity reactions.

IDIOSYNCRATIC REACTIONS
❖ Unexpected drug reactions caused by a genetically
determined susceptibility results:
➢ Extreme sensitivity to a low dose
➢ Extreme insensitivity to a high dose
➢ Unpredictable or unexplainable symptoms
➢ Results in paradoxical reactions (opposite of desired)
■ Eg: a sedative is given for insomnia, but instead
keeps the patient awake

DRUG INTERACTIONS
❖ Additive effect
➢ 2 drugs with similar actions are taken for a doubled
effect (1 + 1 = 2)
➢ Ibuprofen + paracetamol = added analgesic effect
❖ Synergistic
➢ Combined effect of 2 drugs is greater than sum of the
effect or each drug given alone (1+1=3)
➢ Aspirin + codeine = greater analgesic effect
❖ Potentiation
➢ A drug that has no effect enhances the effect of a 2nd
drug (0+1=2)
❖ Antagonistic
➢ One drug inhibits the effect of another drug (1+1=0)
➢ Tetracycline + antacid = decreased absorption of
tetracycline