Side effect

Summary

In medicine, a side effect is an effect of the use of a medicinal drug or other treatment, usually adverse but sometimes beneficial, that is unintended. 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.[1] 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, ≥ 110
  • Common (frequent), 110 to 1100
  • Uncommon (infrequent), 1100 to 11000
  • Rare, 11000 to 110000
  • Very rare, < 110000

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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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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  1. ^ Due A (2023). "What are side effects?". European Journal for Philosophy of Science. 13 (1): 16. doi:10.1007/s13194-023-00519-8. PMC 10006551. PMID 36936702.
  2. ^ "Nicotine Side Effects". Drugs.com.
  3. ^ Schraufnagel DE, Blasi F, Drummond MB, Lam DC, Latif E, Rosen MJ, et al. (September 2014). "Electronic cigarettes. A position statement of the forum of international respiratory societies". American Journal of Respiratory and Critical Care Medicine. 190 (6): 611–8. doi:10.1164/rccm.201407-1198PP. PMID 25006874. S2CID 43763340.
  4. ^ "Common and Rare Side Effects for misoprostol oral".
  5. ^ "Definitions" (PDF). 8 May 2007. Archived from the original (PDF) on 4 March 2016.
  6. ^ "A Guideline on Summary of Product Characteristics" (PDF). European commission. 1 September 2009.
  7. ^ Mühlbauer V, Mühlhauser I (November 2015). "Understanding adverse drug reactions in package leaflets - an exploratory survey among health care professionals". BMC Health Services Research. 15 (1): 505. doi:10.1186/s12913-015-1160-1. PMC 4641349. PMID 26554666.
  8. ^ Mühlbauer V, Prinz R, Mühlhauser I, Wegwarth O (13 September 2018). "Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey". PLOS ONE. 13 (9): e0203800. Bibcode:2018PLoSO..1303800M. doi:10.1371/journal.pone.0203800. PMC 6136776. PMID 30212555.
  9. ^ Boseley S (17 June 2006). "Drugs firm blocks cheap blindness cure". The Guardian. London. Retrieved 20 May 2010.
  10. ^ Gracer R (February 2007). "The Buprenorphine Effect on Depression" (PDF). naabt.org. National Alliance of Advocates for Buprenorphine Treatment. Retrieved 19 September 2015.
  11. ^ Bodkin JA, Zornberg GL, Lukas SE, Cole JO (February 1995). "Buprenorphine treatment of refractory depression". Journal of Clinical Psychopharmacology. 15 (1): 49–57. doi:10.1097/00004714-199502000-00008. PMID 7714228.
  12. ^ Leehey K (1 August 2003). "Mood Stabilizers for Bipolar Disorder (Manic Depressive)". Leeheymd.com. Archived from the original on 13 November 2011. Retrieved 17 August 2011.
  13. ^ a b Wing DA, Powers B, Hickok D (April 2010). "U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States". Obstetrics and Gynecology. 115 (4): 825–833. doi:10.1097/AOG.0b013e3181d53843. PMID 20308845.
  14. ^ Shen WW, Mahadevan J, Hofstatter L, Sata LS (July 1983). "Doxepin as a potent H2 and H2 antihistamine for epigastric distress". The American Journal of Psychiatry. 140 (7): 957–8. doi:10.1176/ajp.140.7.957. PMID 6859336. Archived from the original on 4 September 2011.
  15. ^ "Off-label Use of Gabapentin" (PDF). Idaho Drug Utilization Review, educational leaflet. 2004. Archived from the original (PDF) on 9 August 2007.
  16. ^ "Pregnancy". drugs.nmihi.com. (New Medical Information and Health Information). Archived from the original on 11 October 2008.
  17. ^ Deem SG. "Premature Ejaculation". Emedicine.com. Archived from the original on 1 December 2008. Retrieved 17 August 2011.
  18. ^ Gelenberg AJ, Freeman MP, Markowitz JC, et al. (2010). "Practice guideline for the treatment of patients with major depressive disorder" (PDF). Am J Psychiatry. 167 (Suppl 10): 9–118.
  19. ^ Cheshire WP, Fealey RD (2008). "Drug-induced hyperhidrosis and hypohidrosis: incidence, prevention and management". Drug Safety. 31 (2): 109–26. doi:10.2165/00002018-200831020-00002. PMID 18217788. S2CID 23041000.
  20. ^ World Health Organization model list of essential medicines: 22nd list. Geneva: World Health Organization. 2021. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
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  • "MedEffect Canada". Health Canada. 13 July 2011.
  • "Definitions" (PDF). World Health Organization.