Adverse effect
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In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.
An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not a complication. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects only occur only when starting, increasing or discontinuing a treatment.
Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen.
The harmful outcome is usually indicated by some result such as morbidity, mortality, alteration in body weight, levels of enzymes, loss of function, or as a pathological change detected at the microscopic, macroscopic or physiological level. It may also be indicated by symptoms reported by a patient. Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures, such as drug interactions.
In clinical trials, a distinction is made between adverse events (AEs) and serious adverse events (SAEs). Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE. The results of these trials are often included in the labeling of the medication to provide information both for patients and the prescribing physicians.
Examples of adverse effects associated with specific medications
- Abortion, miscarriage or uterine hemorrhage associated with misoprostol (Cytotec), a labor-inducing drug (this is a case where the adverse effect has been used legally and illegally for performing abortions)
- Addiction to many sedatives and analgesics, such as diazepam, morphine, etc.
- Birth defects associated with thalidomide and isotretinoin (Accutane)
- Bleeding of the intestine associated with aspirin therapy
- Cardiovascular disease associated with COX-2 inhibitors (i.e. Vioxx)
- Deafness and kidney failure associated with gentamicin (an antibiotic)
- Death, following sedation, in children using propofol (Diprivan)
- Dementia associated with coronary artery bypass surgery
- Depression or hepatic injury caused by interferon
- Diabetes caused by atypical antipsychotic medications (neuroleptic psychiatric drugs)
- Diarrhea caused by the use of orlistat (Xenical)
- Erectile dysfunction associated with many drugs, such as antidepressants
- Fever associated with vaccination (in the past, imperfectly manufactured vaccines, such as Bacillus Calmette-Guérin (BCG) and poliomyelitis, have caused the very disease they intended to fight)
- Glaucoma associated with corticosteroid-based eye drops
- Hair loss and anemia may be caused by chemotherapy against cancer, leukemia, etc.
- Headache following spinal anaesthesia
- Hypertension in ephedrine users, which prompted FDA to remove the dietary supplement status of ephedra extracts
- Insomnia caused by stimulants, methylphenidate (Ritalin), Adderall, etc.
- Lactic acidosis associated with the use of stavudine (Zerit, for HIV therapy) or metformin (for diabetes)
- Mania caused by corticosteroids [1]
- Liver damage from paracetamol
- Melasma and thrombosis associated with use of estrogen-containing hormonal contraception, such as the combined oral contraceptive pill
- Priapism associaded with the use of sildenafil
- Rhabdomyolysis associated with statins (anticholesterol drugs)
- Seizures caused by withdrawal from benzodiazepines
- Drowsiness or increase in appetite due to antihistamine use. Some antihistamines are used in sleep aids explicitly because they cause drowsiness.
- Stroke or heart attack associated with sildenafil (Viagra), when used with nitroglycerin
- Suicide, increased tendency associated to the use of fluoxetine and other selective serotonin reuptake inhibitor (SSRI) antidepressants
- Tardive dyskinesia associated with long-term use of metoclopramide and many antipsychotic medications
See also
- Biosafety
- Classification of Pharmaco-Therapeutic Referrals
- Consultant pharmacist
- Drug interaction
- EudraVigilance
- Evidence-based medicine
- List of pharmaceutical companies
- List of withdrawn drugs
- Medical algorithm
- Medical prescription
- Nocebo
- Patient safety
- Perioperative mortality
- Pharmacotoxicology
- Placebo
- Polypharmacy
- Toxicology