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In This Topic
Drugs
Adverse Drug Reactions
Overview of Adverse Drug Reactions
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Chapters in Drugs
  • Overview of Drugs
  • Administration and Kinetics of Drugs
  • Drug Dynamics
  • Factors Affecting Response to Drugs
  • Adverse Drug Reactions
  • Adherence to Drug Treatment
  • Trade-Name and Generic Drugs
  • Over-the-Counter Drugs
Topics in Adverse Drug Reactions
  • Overview of Adverse Drug Reactions
  • Types of Adverse Drug Reactions
  • Severity of Adverse Drug Reactions
  • Benefits Versus Risks of Drugs
  • Risk Factors for Adverse Drug Reactions
  • Allergies to Drugs
  • Overdose Toxicity
 
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Overview of Adverse Drug Reactions

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In the early 1900s, German scientist Paul Ehrlich described an ideal drug as a "magic bullet." Such a drug would be aimed precisely at a disease site and would not harm healthy tissues. Although many new drugs are aimed more accurately than their predecessors, none of them, as of yet, hit the target exclusively.

Most drugs produce several effects, but usually only one effect—the therapeutic effect—is wanted for the treatment of a disorder. The other effects may be regarded as unwanted, whether they are intrinsically harmful or not. For example, certain antihistamines cause drowsiness as well as control the symptoms of allergies. When an over-the-counter sleep aid containing an antihistamine is taken, drowsiness is considered a therapeutic effect. But when an antihistamine is taken to control allergy symptoms during the daytime, drowsiness is considered an annoying, unwanted effect.

Most people, including health care practitioners, refer to unwanted effects as side effects; another term used is adverse drug event. However, the term adverse drug reaction is technically more appropriate for drug effects that are unwanted, unpleasant, noxious, or potentially harmful.

Not surprisingly, adverse drug reactions are common. Most adverse drug reactions are relatively mild, and many disappear when the drug is stopped or the dose is changed. Some gradually subside as the body adjusts to the drug. Other adverse drug reactions are more serious and last longer. About 3 to 7% of all hospital admissions in the United States are for treatment of adverse drug reactions. Adverse drug reactions occur during 10 to 20% of hospital admissions, and about 10 to 20% of these reactions are severe.

Digestive disturbances—loss of appetite, nausea, a bloating sensation, constipation, and diarrhea—are particularly common adverse drug reactions, because most drugs are taken by mouth and pass through the digestive tract. However, almost any organ system can be affected. In older people (Aging and Drugs), the brain is commonly affected, often resulting in drowsiness and confusion.

Some adverse drug reactions are identified when a drug is being tested before it is submitted to the Food and Drug Administration (FDA) for approval. Other adverse drug reactions, typically those that are uncommon, are not detected until the drug has been on the market long enough to be used by a large number of people. Thus, doctors are required to report suspected adverse drug reactions to the FDA.

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Some Serious Adverse Drug Reactions

Adverse Drug Reaction

Types of Drugs

Examples

Anemia (resulting from decreased production or increased destruction of red blood cells)

Certain antibiotics

ChloramphenicolSome Trade Names
CHLORAMPHENICOL

Drugs used to treat malaria or tuberculosis in people with G6PD enzyme deficiency

ChloroquineSome Trade Names
ARALEN

Isoniazid

Primaquine

Angioedema (swelling of the lips, tongue, and throat causing difficulty breathing)

ACE inhibitors

CaptoprilSome Trade Names
CAPOTEN

EnalaprilSome Trade Names
VASOTEC

LisinoprilSome Trade Names
PRINIVIL

Bone fractures

Proton pump inhibitors

EsomeprazoleSome Trade Names
NEXIUM

LansoprazoleSome Trade Names
PREVACID

OmeprazoleSome Trade Names
PRILOSEC

Blood clots

Birth control drugs (all forms including patches and pills)

Drospirenone/ethinyl estradiolSome Trade Names
CLIMARA MENOSTAR

Norelgestromin/ethinyl estradiolSome Trade Names
CLIMARA MENOSTAR

Confusion and drowsiness

Sedatives, including many antihistamines

DiphenhydramineSome Trade Names
BENADRYL

Antidepressants (especially in older people)

Amitriptyline

ImipramineSome Trade Names
TOFRANIL

Decreased production of white blood cells, with increased risk of infection

Certain antipsychotic drugs

ClozapineSome Trade Names
CLOZARIL

Chemotherapy drugs

CyclophosphamideSome Trade Names
LYOPHILIZED CYTOXAN

MercaptopurineSome Trade Names
PURINETHOL

MethotrexateSome Trade Names
TREXALL

Vinblastine

Some drugs used to treat thyroid disorders

Propylthiouracil

Kidney damage

NSAIDs (repeated use of excessive doses)

IbuprofenSome Trade Names
ADVIL MOTRIN

Ketoprofen

NaproxenSome Trade Names
ALEVE ANAPROX NAPROSYN

Aminoglycoside antibiotics

Gentamicin

Kanamycin

Some chemotherapy drugs

CisplatinSome Trade Names
PLATINOL

MethotrexateSome Trade Names
TREXALL

Antifungals

Amphotericin BSome Trade Names
FUNGIZONE

Some antibiotics

Gentamicin

TetracyclineSome Trade Names
SUMYCIN
(outdated)

Liver damage

Some analgesics

AcetaminophenSome Trade Names
TYLENOL
(use of excessive doses)

Some drugs used to treat tuberculosis

Isoniazid

Iron supplements (in excessive amounts)

—

Antidepressants

DuloxetineSome Trade Names
CYMBALTA

Antibiotics

TetracyclineSome Trade Names
SUMYCIN

Muscle tissue destruction (rhabdomyolysis)

Statins

AtorvastatinSome Trade Names
LIPITOR

SimvastatinSome Trade Names
ZOCOR

Stomach or intestinal ulcers (with or without bleeding)

NSAIDs

AspirinSome Trade Names
BAYER

IbuprofenSome Trade Names
ADVIL MOTRIN

Ketoprofen

NaproxenSome Trade Names
ALEVE ANAPROX NAPROSYN

Anticoagulants

Heparin

WarfarinSome Trade Names
COUMADIN

Bisphosphonates

AlendronateSome Trade Names
FOSAMAX

EtidronateSome Trade Names
DIDRONEL

RisedronateSome Trade Names
ACTONEL

Toxic epidermal necrolysis (see Hypersensitivity and Inflammatory Skin Disorders: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis)

Some antibiotics

Penicillins

Quinolones

Anticonvulsants

PhenytoinSome Trade Names
DILANTIN

Valproic acid

Ventricular tachycardia (see Abnormal Heart Rhythms: Ventricular Tachycardia)

Antiarrhythmics

Amiodorone

Procainamide

SotalolSome Trade Names
BETAPACE

Antipsychotics

Chlorpromazine

HaloperidolSome Trade Names
HALDOL

LithiumSome Trade Names
LITHOBID

ACE = angiotensin-converting enzyme; G6PD = glucose-6-phosphate dehydrogenase; NSAIDs = nonsteroidal anti-inflammatory drugs.

Some Serious Adverse Drug Reactions

Adverse Drug Reaction

Types of Drugs

Examples

Anemia (resulting from decreased production or increased destruction of red blood cells)

Certain antibiotics

ChloramphenicolSome Trade Names
CHLORAMPHENICOL

Drugs used to treat malaria or tuberculosis in people with G6PD enzyme deficiency

ChloroquineSome Trade Names
ARALEN

Isoniazid

Primaquine

Angioedema (swelling of the lips, tongue, and throat causing difficulty breathing)

ACE inhibitors

CaptoprilSome Trade Names
CAPOTEN

EnalaprilSome Trade Names
VASOTEC

LisinoprilSome Trade Names
PRINIVIL

Bone fractures

Proton pump inhibitors

EsomeprazoleSome Trade Names
NEXIUM

LansoprazoleSome Trade Names
PREVACID

OmeprazoleSome Trade Names
PRILOSEC

Blood clots

Birth control drugs (all forms including patches and pills)

Drospirenone/ethinyl estradiolSome Trade Names
CLIMARA MENOSTAR

Norelgestromin/ethinyl estradiolSome Trade Names
CLIMARA MENOSTAR

Confusion and drowsiness

Sedatives, including many antihistamines

DiphenhydramineSome Trade Names
BENADRYL

Antidepressants (especially in older people)

Amitriptyline

ImipramineSome Trade Names
TOFRANIL

Decreased production of white blood cells, with increased risk of infection

Certain antipsychotic drugs

ClozapineSome Trade Names
CLOZARIL

Chemotherapy drugs

CyclophosphamideSome Trade Names
LYOPHILIZED CYTOXAN

MercaptopurineSome Trade Names
PURINETHOL

MethotrexateSome Trade Names
TREXALL

Vinblastine

Some drugs used to treat thyroid disorders

Propylthiouracil

Kidney damage

NSAIDs (repeated use of excessive doses)

IbuprofenSome Trade Names
ADVIL MOTRIN

Ketoprofen

NaproxenSome Trade Names
ALEVE ANAPROX NAPROSYN

Aminoglycoside antibiotics

Gentamicin

Kanamycin

Some chemotherapy drugs

CisplatinSome Trade Names
PLATINOL

MethotrexateSome Trade Names
TREXALL

Antifungals

Amphotericin BSome Trade Names
FUNGIZONE

Some antibiotics

Gentamicin

TetracyclineSome Trade Names
SUMYCIN
(outdated)

Liver damage

Some analgesics

AcetaminophenSome Trade Names
TYLENOL
(use of excessive doses)

Some drugs used to treat tuberculosis

Isoniazid

Iron supplements (in excessive amounts)

—

Antidepressants

DuloxetineSome Trade Names
CYMBALTA

Antibiotics

TetracyclineSome Trade Names
SUMYCIN

Muscle tissue destruction (rhabdomyolysis)

Statins

AtorvastatinSome Trade Names
LIPITOR

SimvastatinSome Trade Names
ZOCOR

Stomach or intestinal ulcers (with or without bleeding)

NSAIDs

AspirinSome Trade Names
BAYER

IbuprofenSome Trade Names
ADVIL MOTRIN

Ketoprofen

NaproxenSome Trade Names
ALEVE ANAPROX NAPROSYN

Anticoagulants

Heparin

WarfarinSome Trade Names
COUMADIN

Bisphosphonates

AlendronateSome Trade Names
FOSAMAX

EtidronateSome Trade Names
DIDRONEL

RisedronateSome Trade Names
ACTONEL

Toxic epidermal necrolysis (see Hypersensitivity and Inflammatory Skin Disorders: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis)

Some antibiotics

Penicillins

Quinolones

Anticonvulsants

PhenytoinSome Trade Names
DILANTIN

Valproic acid

Ventricular tachycardia (see Abnormal Heart Rhythms: Ventricular Tachycardia)

Antiarrhythmics

Amiodorone

Procainamide

SotalolSome Trade Names
BETAPACE

Antipsychotics

Chlorpromazine

HaloperidolSome Trade Names
HALDOL

LithiumSome Trade Names
LITHOBID

ACE = angiotensin-converting enzyme; G6PD = glucose-6-phosphate dehydrogenase; NSAIDs = nonsteroidal anti-inflammatory drugs.

Last full review/revision October 2012 by Joan B. Tarloff, PhD

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Pronunciations

acetaminophen

amitriptyline

amphotericin B

angioedema

angiotensin

anticoagulants

chloramphenicol

chlorpromazine

clozapine

cyclophosphamide

dehydrogenase

diphenhydramine

edema

glucose-6-phosphate dehydrogenase

haloperidol

imipramine

isoniazid

ketoprofen

lansoprazole

lithium

malaria

mercaptopurine

methotrexate

naproxen

omeprazole

phenytoin

propylthiouracil

quinolones

tachycardia

toxic epidermal necrolysis

ventricular

ventricular tachycardia

warfarin

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Next: Types of Adverse Drug Reactions

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