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Side effect
Side effect
Side effect
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In medicine, a side effect is an unintended effect caused by a medicinal drug or other treatment's capacities or properties, and these effects are often adverse but sometimes beneficial.[1] Herbal and traditional medicines also have side effects.

A drug or procedure usually used for a specific effect may be used specifically because of a beneficial side-effect; this is termed "off-label use" until such use is approved. For instance, X-rays have long been used as an imaging technique; the discovery of their oncolytic capability led to their use in radiotherapy for ablation of malignant tumours.

Frequency of side effects

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Possible side effects of nicotine[2][3]

The World Health Organization and other health organisations characterise the probability of experiencing side effects as:[4][5]

  • Very common, ≥ 1⁄10
  • Common (frequent), 1⁄10 to 1⁄100
  • Uncommon (infrequent), 1⁄100 to 1⁄1000
  • Rare, 1⁄1000 to 1⁄10000
  • Very rare, < 1⁄10000

The European Commission recommends that the list should contain only effects where there is "at least a reasonable possibility" that they are caused by the drug and the frequency "should represent crude incidence rates (and not differences or relative risks calculated against placebo or other comparator)".[6] The frequency describes how often symptoms appear after taking the drug, without assuming that they were necessarily caused by the drug. Both healthcare providers[7] and lay people[8] misinterpret the frequency of side effects as describing the increase in frequency caused by the drug.

Examples of therapeutic side effects

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See also: Serendipity

Most drugs and procedures have a multitude of reported adverse side effects; the information leaflets provided with virtually all drugs list possible side effects. Beneficial side effects are less common; some examples, in many cases of side-effects that ultimately gained regulatory approval as intended effects, are:

See also

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References

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[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Side effect

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from Grokipedia
A side effect is any unintended response to a or medical treatment that occurs alongside its primary therapeutic purpose, potentially ranging from minor and transient issues like drowsiness or upset stomach to severe, life-threatening reactions such as organ damage or allergic responses. These effects can be predictable and dose-related or arise unpredictably due to individual factors, and while some may resolve on their own after discontinuation, others require immediate medical intervention. In clinical contexts, side effects are distinguished from the drug's intended action but are integral to , as they influence treatment decisions and regulatory approvals. The study and management of side effects fall under adverse drug reaction (ADR) monitoring, where organizations like the define them as unintended pharmacological effects at normal doses, encompassing both harmful and occasionally beneficial outcomes. During , side effects are identified through rigorous clinical trials, but many only emerge post-approval via real-world use, prompting systems like the FDA's MedWatch program for voluntary reporting by patients and providers. Common causes include drug interactions with other medications, food, or underlying health conditions, with prevalence varying by — for instance, antibiotics often cause gastrointestinal upset, while agents may lead to broader systemic impacts. Addressing side effects typically involves strategies such as dosage reduction, therapeutic substitution, or adjunctive therapies to alleviate symptoms while preserving efficacy, emphasizing the balance between benefits and risks in . Ongoing focuses on predictive modeling and genomic testing to anticipate and minimize these effects, reducing the global burden of adverse drug events, which represent a significant burden and contribute substantially to healthcare costs. plays a crucial role, empowering individuals to recognize and report symptoms early, thereby enhancing overall drug safety profiles.

Definition and Basics

Definition

In pharmacology and medicine, a side effect is defined as any unintended or secondary effect of a drug, treatment, or medical procedure that occurs beyond its primary therapeutic goal. This encompasses effects that may arise from the drug's pharmacological properties at standard doses, distinguishing them from the intended outcome such as symptom relief or disease modification. The term "side effect" first appeared in general usage in to describe subsidiary consequences of actions, but its application in and pharmacological contexts emerged in 1939 to characterize non-target outcomes of therapeutic interventions. Side effects differ from the primary effect in that they manifest concurrently or subsequently to the desired action, often at the same therapeutic dose, and are typically predictable based on the drug's mechanism. While many side effects are benign or manageable, some qualify as adverse reactions when they pose harm, though this classification is explored further in dedicated contexts.

Intended vs. Unintended Effects

In , effects of a are classified as intended or unintended based on their alignment with the therapeutic purpose for which the drug is prescribed. Intended effects, also known as therapeutic effects, are those that achieve the primary goal of treatment, such as pain relief from an like aspirin. In contrast, unintended effects, often termed side effects, are secondary outcomes arising from the drug's causal mechanisms that were not the reason for its administration, such as drowsiness or gastrointestinal upset from the same . This classification hinges on the prescriber's intention and the intervention's inherent pharmacological properties, where side effects are explicitly defined as stemming from the drug's action. The designation of an effect as intended or unintended can shift depending on the therapeutic context, illustrating the relativity of this classification. For instance, the vasodilatory action of was originally intended for treating severe , but its promotion of growth was initially an unintended side effect observed in patients. Subsequent recognition of this effect led to its reformulation and approval as a topical treatment for androgenetic alopecia, where growth became the intended therapeutic outcome while emerged as a potential side effect at lower doses. Similarly, immunosuppressive effects of drugs like corticosteroids are intended in to prevent graft rejection but may manifest as unintended side effects, such as increased susceptibility, when the same agents are used primarily for purposes in other conditions. These contextual variations underscore that an effect's status is not inherent to the drug but determined by the clinical indication and user intent. In clinical practice, this distinction guides physicians in prescribing by requiring a careful of the intended benefits against the potential unintended risks to optimize outcomes. For example, when selecting an antihypertensive, a might favor a with strong intended blood pressure-lowering despite known unintended metabolic side effects, provided the overall benefit-risk profile supports its use in the 's specific . This assessment involves integrating evidence from clinical trials, history, and regulatory data to ensure that the therapeutic gains outweigh any secondary harms, thereby informing and monitoring strategies.

Classification

Adverse Side Effects

Adverse side effects, also known as adverse drug reactions (ADRs), refer to unintended and harmful responses to a that occur at doses normally used for prophylaxis, , or therapy. These effects can range from mild discomforts, such as or , to severe outcomes like organ damage or , often necessitating discontinuation of the drug or medical intervention. Unlike intended therapeutic actions, adverse effects arise from the drug's interaction with the body in unanticipated ways, potentially impacting and treatment adherence. Classification of adverse side effects by severity helps in clinical assessment and management, with standardized scales providing a framework for grading their intensity. The Common Terminology Criteria for Adverse Events (CTCAE), developed by the , categorizes effects into five grades: Grade 1 (mild; asymptomatic or mild symptoms, no intervention needed), Grade 2 (moderate; minimal intervention required), Grade 3 (severe; medically significant but not immediately life-threatening), Grade 4 (life-threatening; urgent intervention indicated), and Grade 5 (death related to the ). This grading aids healthcare providers in weighing risks against benefits and guiding regulatory decisions. A key classification of ADRs distinguishes between Type A (augmented) reactions, which are predictable, dose-related, and common (e.g., gastrointestinal upset from antibiotics), and Type B (bizarre) reactions, which are unpredictable, idiosyncratic, and often immune-mediated (e.g., ). Common categories of adverse side effects include allergic reactions, , and organ-specific damage. Allergic reactions encompass responses, such as rashes, urticaria, or , triggered by immune-mediated mechanisms to otherwise tolerated drugs. refers to dose-dependent harm from excessive drug exposure, leading to symptoms like gastrointestinal distress or , often due to impaired metabolism. Organ-specific damage, exemplified by ( causing elevated enzymes or failure) or (kidney impairment), targets particular systems and may result from direct cellular or idiosyncratic responses. These categories highlight the diverse pathways through which adverse effects manifest, underscoring the need for vigilant monitoring.

Therapeutic Side Effects

Therapeutic side effects are unintended secondary effects of a that confer additional benefits, distinct from the 's primary therapeutic purpose. Unlike adverse effects, these can be harnessed for new medical applications, often through the process of repurposing. In , such effects arise from off-target interactions with biological pathways, providing opportunities to expand a drug's indications without the need for entirely new development. A prominent historical example is , developed in the 1970s as an oral vasodilator for severe . During clinical trials, researchers observed —excessive hair growth—as an unintended side effect in patients, particularly on the face, scalp, and extremities. This observation, initially noted in 1971, led to targeted studies on its potential for treating hair loss. By reformulating minoxidil as a topical solution and conducting dedicated trials, it was approved by the FDA in 1988 for androgenetic alopecia, transforming an antihypertensive into a leading therapy for baldness. The process of identifying therapeutic side effects typically begins with clinical during trials or routine patient care, where unexpected benefits are documented and hypothesized. Subsequent steps involve preclinical validation to elucidate mechanisms, followed by focused clinical studies to confirm and for the new indication. Post-marketing surveillance systems, such as those monitored by regulatory agencies, further aid detection by aggregating real-world data. This iterative approach, often driven by , has enabled rapid while minimizing development timelines and costs compared to de novo drug .

Mechanisms and Causes

Pharmacological Mechanisms

Side effects in often arise from unintended drug-receptor interactions, where a binds to non-target receptors, triggering physiological responses beyond its therapeutic intent. For instance, first-generation antihistamines like diphenhydramine can cross the blood-brain barrier and bind to histamine H1 receptors in the , leading to as an off-target effect. This off-target binding occurs due to structural similarities between target and non-target receptors, allowing the drug to interact with multiple sites in the body, which can disrupt normal signaling pathways such as those involving G-protein coupled receptors or ion channels. Metabolic pathways play a critical role in generating side effects through the of drugs into active or toxic s, primarily mediated by hepatic enzymes. The (CYP450) family, including isoforms like and , oxidizes many xenobiotics, sometimes producing reactive intermediates that cause cellular damage, such as from acetaminophen's . These enzymes exhibit polymorphism and substrate specificity, leading to idiosyncratic toxicities when shifts toward harmful byproducts rather than . Inhibition or induction of CYP450 by co-administered drugs can further amplify these risks, altering profiles and exacerbating side effects. Dose-response relationships underpin the emergence of side effects, as therapeutic doses maintain within a narrow window, while higher exposures exceed safety thresholds, activating adverse pathways. Conceptually, the illustrates a sigmoidal progression where low doses yield minimal effects, therapeutic levels achieve desired outcomes, and supratherapeutic doses provoke through receptor saturation or metabolic overload. Side effects typically manifest on the ascending or plateau phases of this , highlighting the importance of therapeutic indices—the of toxic to effective doses—to predict and mitigate risks. Individual factors can modulate these curves, as explored in related sections on patient-specific influences.

Patient-Specific Factors

Patient-specific factors play a crucial role in determining the occurrence, severity, and type of side effects experienced from medications, as individual biological, demographic, and environmental variations can significantly alter responses. These factors introduce variability beyond the inherent properties of the drug itself, influencing how it is processed, tolerated, and interacts within the body. Understanding these influences is essential for approaches that aim to minimize adverse outcomes. Genetic variations, particularly in , substantially affect and the risk of side effects. Polymorphisms in the 2D6 () gene, for instance, lead to distinct metabolizer phenotypes—such as poor, intermediate, extensive, or ultrarapid—that alter the activation or clearance of substrates like antidepressants, opioids, and beta-blockers. For drugs inactivated by like metoprolol, poor metabolizers experience elevated plasma concentrations of the parent drug, increasing the likelihood of adverse reactions such as enhanced hypotensive effects. For prodrugs like that require for activation to , poor metabolizers have reduced efficacy due to insufficient formation, along with potentially more -related side effects from higher parent drug levels. Conversely, ultrarapid metabolizers of such prodrugs may produce excessive , increasing toxicity risks, as seen with leading to overdose. These genetic differences underscore the importance of in predicting side effect risks for CYP2D6-metabolized drugs. Demographic characteristics, including age, , and comorbidities, further modulate side effect profiles through physiological changes and interactions. In older adults, age-related declines in renal and hepatic function, along with reduced physiological reserve, heighten susceptibility to side effects, particularly renal from like nonsteroidal agents or aminoglycosides. Comorbidities exacerbate this ; for example, patients with or are more prone to imbalances or fluid retention from diuretics and antihypertensives. differences also contribute, with women generally experiencing a higher incidence of adverse reactions due to pharmacokinetic variations, such as slower clearance and higher body fat distribution, which can prolong exposure to lipophilic compounds. These demographic influences highlight the need for dose adjustments and monitoring tailored to patient profiles. Lifestyle and environmental factors, such as diet, , and concurrent exposures, can amplify or mitigate side effects by affecting absorption, distribution, and interactions. Dietary components interact with medications; for instance, high-fat meals may delay gastric emptying and enhance bioavailability of lipophilic drugs like , potentially intensifying gastrointestinal side effects, while inhibits enzymes, elevating levels of statins and increasing risk. , common in patients managing multiple conditions, heightens the potential for drug-drug interactions that precipitate side effects, such as from combined antidepressants or bleeding risks from concurrent anticoagulants and antiplatelets. Environmental factors like can induce activity, accelerating metabolism of and reducing its efficacy while altering side effect thresholds. Addressing these modifiable factors through counseling can help optimize therapeutic outcomes and reduce adverse events.

Frequency and Assessment

Incidence and Prevalence

The incidence of side effects, often referred to as adverse drug reactions (ADRs) when unintended and harmful, varies significantly depending on the drug, patient population, and setting. In outpatient settings, the pooled of ADRs is approximately 8.32%, with mild effects such as or commonly reported in 10-20% of cases for frequently prescribed medications like antibiotics and analgesics. Recent studies indicate ADRs affect approximately 6-10% of hospitalized patients overall, with estimates around 6.2% (95% CI 5.1-7.2%) in a 2025 meta-analysis, and serious events varying from 3.5% to 10.1% depending on the region and methodology. Regulatory classifications further categorize side effect frequencies as very common (affecting more than 1 in 10 ), common (1 in 100 to 1 in 10), uncommon (1 in 1,000 to 1 in 100), rare (1 in 10,000 to 1 in 1,000), and very rare (fewer than 1 in 10,000), providing a standardized framework for assessing occurrence across treatments. Measurement of side effect incidence is influenced by differences between controlled clinical trials and real-world post-marketing . Clinical trials, involving selected populations under strict monitoring, primarily detect common ADRs occurring in more than 1% of participants, but they often underrepresent rare or long-term effects due to limited sample sizes and duration. In contrast, post-marketing data from spontaneous reporting systems reveal broader patterns but suffer from substantial underreporting, estimated at over 90% for all ADRs and up to 95% for serious ones, leading to incomplete estimates in everyday . This underreporting is exacerbated by factors such as time constraints and gaps, resulting in lower documented rates in routine care compared to intensive study environments. Over the past decade (2015-2025), documentation of side effects has trended upward globally, driven by enhanced efforts, including mandatory reporting requirements and digital surveillance tools, with significant increases in ADR report submissions observed across multiple countries as of 2022. As of 2025, has seen further boosts from surveillance and AI-assisted signal detection. Reporting rates vary widely by country income level, with high-income countries often exceeding hundreds to over a thousand reports per million inhabitants annually (e.g., 1,130 in in 2019), while low- and middle-income countries typically report far lower figures, often below 10 per million, reflecting disparities in healthcare infrastructure and regulatory enforcement. These variations underscore the role of improved international systems, such as the WHO's VigiBase, in bridging gaps and elevating overall awareness of side effect prevalence.

Reporting and Monitoring

Reporting and monitoring of side effects, particularly adverse drug reactions, occur primarily through post-approval systems designed to detect, assess, and mitigate risks after a reaches the market. These efforts involve both regulatory-mandated reporting mechanisms and clinical practices to ensure ongoing safety surveillance. In the United States, the (FDA) operates the MedWatch program as the primary system for voluntary and mandatory reporting of adverse events associated with prescription drugs, over-the-counter medications, biologics, and medical devices. Healthcare professionals, patients, and consumers can submit reports via online forms, phone, or mail, detailing suspected side effects to facilitate FDA's analysis and potential regulatory actions such as label updates or product withdrawals. Mandatory reporting is required for manufacturers and healthcare providers in cases of serious events, while voluntary reports from the public help identify rare or emerging issues not captured in pre-approval trials. Similarly, in the , the (EMA) manages EudraVigilance, a for collecting, managing, and analyzing reports of suspected adverse reactions to medicines authorized or under study in the region. Marketing authorization holders, sponsors, and national competent authorities submit individual case safety reports electronically, enabling real-time signal detection and across the EU. The system supports both individual case evaluations and analysis to inform safety decisions, with public access to anonymized reports promoting transparency. Pharmacovigilance encompasses systematic processes for signal detection and causality assessment to evaluate reported side effects. Signal detection involves statistical and non-statistical methods to identify potential safety issues from disparate sources like spontaneous reports and , using tools such as disproportionality in databases like the FDA Adverse Event Reporting System (FAERS) or EudraVigilance. Once a signal is identified, causality assessment determines the likelihood that a caused the observed effect, often employing standardized scales like the , a 10-question probabilistic tool scoring factors such as temporal association, dechallenge, and rechallenge to categorize reactions as definite, probable, possible, or doubtful. This algorithm, developed in 1981, aids in standardizing evaluations across reports to prioritize follow-up investigations. In clinical settings, ongoing monitoring of side effects integrates patient-reported , laboratory evaluations, and records to track individual responses during treatment. diaries allow individuals to document symptoms, adherence, and perceived side effects in real-time, improving accuracy in capturing subjective experiences that might otherwise be underreported during visits. Routine lab tests, such as counts or liver function panels, detect objective indicators of , with thresholds triggering dose adjustments or discontinuation. Electronic health records (EHRs) facilitate integrated by aggregating for automated alerts on potential adverse events, supporting through analysis while enhancing care coordination.

Examples and Case Studies

Common Examples in Medications

One of the most frequently encountered gastrointestinal side effects in medication use is , commonly associated with opioids prescribed for . For instance, opioids such as and often induce in up to 25% of patients, particularly during initial treatment phases, contributing to discomfort that may lead to discontinuation of therapy. Similarly, nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, widely used for and relief, can cause as a minor gastrointestinal disturbance, affecting a notable portion of users and often manifesting alongside dyspepsia. Neurological side effects, such as , are prevalent among antihypertensive medications, particularly beta-blockers like and metoprolol, which are staples in treating high . These drugs frequently lead to or light-headedness due to their impact on blood pressure regulation, with studies indicating an increased risk ( of 1.72) that affects daily activities like standing or driving for many patients. Dermatological reactions, including rashes, represent a common side effect of antibiotics, especially penicillin-based ones such as amoxicillin, used routinely for bacterial infections. Penicillin allergies or sensitivities often present as or maculopapular rashes in approximately 5-10% of treated individuals, prompting immediate medical attention to avoid escalation.

Historical and Notable Cases

One of the most infamous cases of drug-induced side effects is the thalidomide tragedy, which unfolded in the late 1950s and early 1960s. Developed by the German pharmaceutical company Chemie Grünenthal and marketed under names like Contergan, was promoted as a safe for treating in pregnant women, with over 10,000 tons produced and distributed in 46 countries by 1961. However, by 1961, reports emerged linking the drug to severe congenital malformations, particularly —a condition causing shortened or absent limbs—in newborns. An estimated 10,000 to 20,000 children worldwide were born with thalidomide-related birth defects between 1956 and 1962, with approximately 40% of affected infants dying in infancy. In the United States, the disaster was largely averted due to the vigilance of FDA reviewer Frances Kelsey, who rejected approval applications from 1960 to 1961 citing inadequate safety data on and potential fetal risks, despite pressure from the distributor Richardson-Merrell; only 17 U.S. cases were reported from limited investigational use. The tragedy prompted global regulatory reforms, most notably the 1962 Kefauver-Harris Amendments in the U.S., which mandated proof of both safety and for new drugs, required in clinical trials, and strengthened FDA oversight of pharmaceutical advertising and testing protocols. Another landmark incident involved rofecoxib, marketed as Vioxx by Merck & Co., a selective cyclooxygenase-2 (COX-2) inhibitor approved by the FDA in May 1999 for osteoarthritis and acute pain relief, with over 80 million prescriptions filled in the U.S. alone by 2004. Initially hailed for reducing gastrointestinal side effects compared to traditional NSAIDs, Vioxx's cardiovascular risks became evident through post-marketing studies; the Adenomatous Polyp Prevention on Vioxx (APPROVe) trial, halted in September 2004, showed a doubled relative risk of serious cardiovascular events like myocardial infarction and stroke after 18 months of use (3.5% incidence in the Vioxx group versus 1.9% in placebo). Merck voluntarily withdrew Vioxx from the market on September 30, 2004, amid lawsuits estimating up to 27,000 heart attacks or strokes attributable to the drug, leading to settlements exceeding $4.85 billion. This event intensified scrutiny of the entire COX-2 inhibitor class, prompting FDA warnings for similar drugs like celecoxib (Celebrex) and valdecoxib (Bextra, withdrawn in 2005), and highlighting flaws in post-approval surveillance and direct-to-consumer marketing, which had generated over $2.5 billion in annual sales for Vioxx. The scandal spurred congressional investigations into FDA-Merck interactions and reinforced requirements for cardiovascular safety assessments in anti-inflammatory drug trials. The ongoing opioid crisis exemplifies long-term unintended consequences of strategies, rooted in aggressive prescribing practices from the late 1990s onward. Opioids such as (OxyContin, approved in 1995) and were promoted for chronic non-cancer based on assertions of low risk—estimated at under 1% in some early claims—leading to a surge in prescriptions from 76 million in 1991 to 259 million by 2012 in the U.S. , recognized as a key side effect involving (OUD), affects 8-12% of patients on long-term therapy, with misuse rates up to 29%, driven by tolerance, dependence, and reward pathway alterations in the . This overprescription, influenced by pain advocacy campaigns like "pain as the fifth vital sign" in the 1990s and , contributed to over 500,000 overdose deaths from 1999 to 2020, predominantly from prescription and illicit opioids, with totals exceeding 645,000 opioid-involved deaths by 2021 and over 1.1 million total deaths by 2023, marking a declared by the U.S. Department of Health and Human Services in 2017. The crisis has reshaped guidelines, with the CDC issuing restrictive prescribing recommendations in 2016 and 2022, emphasizing non-opioid alternatives and to mitigate risks, and ongoing efforts including to and treatment programs as of 2025.

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