Difference between revisions of "Template:Major side effects of bicalutamide alone"

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{| class="wikitable {{{state<includeonly>|floatright</includeonly>}}}" style="font-size:small; text-align:left; margin-left:auto; margin-right:auto; border:none;"
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{| class="wikitable {{{state<includeonly>|floatright</includeonly>}}}" style="width:30%; text-align:left; margin-left:auto; margin-right:auto; border:none;"
|+ {{Navbar|Major side effects of bicalutamide alone|mini=y}} {{Resize|105%|Major side effects of {{No selflink|bicalutamide}} alone}}
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|+ {{Navbar|Major side effects of bicalutamide alone|mini=y}} Major side effects of {{No selflink|bicalutamide}}<ref name="pmid12231039">{{cite journal | vauthors = Mcleod DG | title = Emerging role of adjuvant hormonal therapy | journal = Urology | volume = 60 | issue = 3 Suppl 1 | pages = 13–20; discussion 21 | date = September 2002 | pmid = 12231039 | doi = 10.1016/S0090-4295(02)01562-5 }}</ref><ref name="PMS-Bicalutamide-Label">https://pdf.hres.ca/dpd_pm/00009096.PDF</ref><ref name="pmid12353966">{{cite journal | vauthors = Bennett CL, Raisch DW, Sartor O | title = Pneumonitis associated with nonsteroidal antiandrogens: presumptive evidence of a class effect |journal=Annals of Internal Medicine | volume = 137 | issue = 7 | pages = 625 | date = October 2002 | pmid = 12353966 | doi = 10.7326/0003-4819-137-7-200210010-00029 | quote = An estimated 0.77% of the 6,480 nilutamide-treated patients, 0.04% of the 41,700 flutamide-treated patients, and 0.01% of the 86,800 bicalutamide-treated patients developed pneumonitis during the study period.}}</ref><ref name="Molina ManceroPicón2016">{{cite journal | last1 = Molina Mancero | first1 = Guillermo | last2 = Picón | first2 = Xavier | last3 = Di Tullio | first3 = Fernando | last4 = Ernst | first4 = Glenda | last5 = Dezanzo | first5 = Pablo | last6 = Salvado | first6 = Alejandro | last7 = Chertcoff | first7 = Julio F | title = Neumonía intersticial inducida por bloqueo androgénico máximo como tratamiento de cáncer de próstata avanzado | trans-title = Fatal interstitial lung disease associated with maximum androgen blockade. Report of one case | journal = Revista médica de Chile | volume = 144 | issue = 10 | year = 2016 | pages = 1356–1359 | issn = 0034-9887 | doi = 10.4067/S0034-98872016001000017}}</ref><ref name="pmid26663090">{{cite journal | vauthors = Lee K, Oda Y, Sakaguchi M, Yamamoto A, Nishigori C | title = Drug-induced photosensitivity to bicalutamide - case report and review of the literature | journal = Photodermatol Photoimmunol Photomed | volume = 32 | issue = 3 | pages = 161–4 | date = May 2016 | pmid = 26663090 | doi = 10.1111/phpp.12230 }}</ref><ref>{{cite journal | last1 = Gretarsdottir | first1 = Helga M. | last2 = Bjornsdottir | first2 = Elin | last3 = Bjornsson | first3 = Einar S. | title = Bicalutamide-Associated Acute Liver Injury and Migratory Arthralgia: A Rare but Clinically Important Adverse Effect | journal = Case Reports in Gastroenterology | volume = 12 | issue = 2 | year = 2018 | pages = 266–270 | issn = 1662-0631 | doi = 10.1159/000485175}}</ref><ref name="pmid12603397">{{cite journal | vauthors = Anderson J | title = The role of antiandrogen monotherapy in the treatment of prostate cancer | journal = BJU Int. | volume = 91 | issue = 5 | pages = 455–61 | date = March 2003 | pmid = 12603397 | doi = 10.1046/j.1464-410X.2003.04026.x | s2cid = 8639102 }}</ref>
 
|-
 
|-
! Frequency !! [[System Organ Class|Class]] !! [[Side effect]]
+
! scope="col" style="width: 50px;"  | Frequency
 +
! scope="col" style="width: 200px;" | [[System Organ Class|Class of effect]]
 +
! scope="col" | Effect
 
|-
 
|-
| style="text-align: center; | Very common<br />(≥10%) || [[Reproductive disorder|Reproductive system]]<br />and [[breast disorder]]s || • [[Breast tenderness]]<sup>a</sup><br />• [[Gynecomastia]]<sup>a</sup>
+
! scope="row" | Very common (≥10%)
 +
| [[Reproductive disorder|Reproductive system]] and [[breast disorder]]s || •{{nbsp}}[[Breast tenderness]]{{efn|group=bic1|name=breast|May occur as often as 90% of those taking bicalutamide, but is mild-to-moderate in 90% of occurrences. Incidence greatly decreased in combination with castration.}}<br />•{{nbsp}}[[Gynecomastia]]{{efn|group=bic1|name=breast}}
 
|-
 
|-
| rowspan="3" style="text-align: center; | Common<br />(≥1% and <10%) || [[General disorder|General]] and [[psychiatric disorder|psychiatric<br />disorder]]s || • [[Asthenia]]<br /> • [[Decreased libido]]<br /> • [[Erectile dysfunction]]<br /> • [[Hot flash]]es
+
! scope="row" rowspan="3"| Common (1-10%)
 +
| [[General disorder|General]] and [[psychiatric disorder]]s || •{{nbsp}}[[Asthenia]]<br /> •{{nbsp}}[[Decreased libido]]<br /> •{{nbsp}}[[Erectile dysfunction]]<br /> •{{nbsp}}[[Hot flash]]es
 
|-
 
|-
| [[Skin and subcutaneous tissue disorders|Skin and subcutaneous<br />tissue disorders]] || • [[Decreased body hair]]
+
| [[Skin and subcutaneous tissue disorders|Skin and subcutaneous<br />tissue disorders]]
 +
| •{{nbsp}}[[Decreased body hair]]
 
|-
 
|-
| [[Hepato-biliary disorder]]s || • [[Elevated liver enzymes]]<sup>b</sup>
+
| [[Hepato-biliary disorder]]s
 +
| •{{nbsp}}[[Elevated liver enzymes]]{{efn|group=bic1|Usually transient, rarely severe. Resolves or improves with continued therapy or on discontinuation.}}
 
|-
 
|-
| style="text-align: center; | Uncommon<br />(≥0.1% and <1%) || [[Immune system disorder]]s || • [[Hypersensitivity reaction]]s,<br />([[angioedema]] and [[urticaria|hives]])
+
! scope="row" | Uncommon (0.1-1%)
 +
| [[Immune system disorder]]s and [[hypersensitivity reaction]]s || •{{nbsp}}[[Angioedema]]<br /> •{{nbsp}}[[Urticaria|Hives]]
 
|-
 
|-
| rowspan="3" style="text-align: center; | Rare (<0.1%)<br />and unknown || [[Respiratory disorder|Respiratory]], [[thoracic disorder|thoracic]], and<br />[[mediastinal disorder]]s || • [[Lung disease]]<sup>c</sup>
+
! scope="row" rowspan="3" | Rare (<0.1%) or unknown
 +
| [[Respiratory disorder]]s || •{{nbsp}}[[Lung disease]]{{efn|group=bic1|name=case|Reported in single cases, but not observed in any large, randomized trial.}}
 
|-
 
|-
| [[Skin and subcutaneous tissue disorders|Skin and subcutaneous<br />tissue disorders]] || • [[Photosensitivity|Sensitivity to light]]
+
| [[Skin and subcutaneous tissue disorders]] || •{{nbsp}}[[Photosensitivity|Sensitivity to light]]
 
|-
 
|-
| [[Hepato-biliary disorder]]s || • [[Hepatotoxicity|Liver toxicity]]<sup>d</sup>
+
| [[Hepato-biliary disorder]]s || •{{nbsp}}[[Hepatotoxicity|Liver toxicity]]{{efn|group=bic1|name=case}}
 
|- class="sortbottom"
 
|- class="sortbottom"
| colspan="3" style="width: 1px; background-color:#eaecf0; text-align: center;" | {{Hidden | <noinclude>expanded = true |</noinclude> header = Footnotes and sources | content = <sup>a</sup> = Incidence of breast changes of up to 80 to 90%. Mild-to-moderate in 90% of cases. Incidence greatly decreased in combination with castration.<br /><sup>b</sup> = Elevated liver enzymes rarely severe and usually transient, resolving or improving with continued therapy or with discontinuation. Incidence of 3.4% relative to 1.9% for placebo in a high-dose 4,000-patient trial.<br /><sup>c</sup> = 17 case reports of interstitial or eosinophilic lung disease (as of 2020). Incidence for interstitial of 0.01% (12 patients) in an 87,000-patient cohort.<br /><sup>d</sup> = 9 case reports of liver toxicity published (as of 2020). No cases in a high-dose 4,000-patient trial (suggesting incidence of <0.03%).<br />{{Center|''Sources:'' <noinclude><ref name="pmid12231039">{{cite journal | vauthors = Mcleod DG | title = Emerging role of adjuvant hormonal therapy | journal = Urology | volume = 60 | issue = 3 Suppl 1 | pages = 13–20; discussion 21 | date = September 2002 | pmid = 12231039 | doi = 10.1016/S0090-4295(02)01562-5 | url = }}</ref><ref name="PMS-Bicalutamide-Label">https://pdf.hres.ca/dpd_pm/00009096.PDF</ref><ref name="pmid12353966">{{cite journal | vauthors = Bennett CL, Raisch DW, Sartor O | title = Pneumonitis associated with nonsteroidal antiandrogens: presumptive evidence of a class effect |journal=Annals of Internal Medicine | volume = 137 | issue = 7 | pages = 625 | date = October 2002 | pmid = 12353966 | doi = 10.7326/0003-4819-137-7-200210010-00029 | quote = An estimated 0.77% of the 6,480 nilutamide-treated patients, 0.04% of the 41,700 flutamide-treated patients, and 0.01% of the 86,800 bicalutamide-treated patients developed pneumonitis during the study period.}}</ref><ref name="Molina ManceroPicón2016">{{cite journal | last1 = Molina Mancero | first1 = Guillermo | last2 = Picón | first2 = Xavier | last3 = Di Tullio | first3 = Fernando | last4 = Ernst | first4 = Glenda | last5 = Dezanzo | first5 = Pablo | last6 = Salvado | first6 = Alejandro | last7 = Chertcoff | first7 = Julio F | title = Neumonía intersticial inducida por bloqueo androgénico máximo como tratamiento de cáncer de próstata avanzado | trans-title = Fatal interstitial lung disease associated with maximum androgen blockade. Report of one case | journal = Revista médica de Chile | volume = 144 | issue = 10 | year = 2016 | pages = 1356–1359 | issn = 0034-9887 | doi = 10.4067/S0034-98872016001000017}}</ref><ref name="pmid26663090">{{cite journal | vauthors = Lee K, Oda Y, Sakaguchi M, Yamamoto A, Nishigori C | title = Drug-induced photosensitivity to bicalutamide - case report and review of the literature | journal = Photodermatol Photoimmunol Photomed | volume = 32 | issue = 3 | pages = 161–4 | date = May 2016 | pmid = 26663090 | doi = 10.1111/phpp.12230 | url = }}</ref><ref>{{cite journal | last1 = Gretarsdottir | first1 = Helga M. | last2 = Bjornsdottir | first2 = Elin | last3 = Bjornsson | first3 = Einar S. | title = Bicalutamide-Associated Acute Liver Injury and Migratory Arthralgia: A Rare but Clinically Important Adverse Effect | journal = Case Reports in Gastroenterology | volume = 12 | issue = 2 | year = 2018 | pages = 266–270 | issn = 1662-0631 | doi = 10.1159/000485175}}</ref><ref name="pmid12603397">{{cite journal | vauthors = Anderson J | title = The role of antiandrogen monotherapy in the treatment of prostate cancer | journal = BJU Int. | volume = 91 | issue = 5 | pages = 455–61 | date = March 2003 | pmid = 12603397 | doi = 10.1046/j.1464-410X.2003.04026.x | url = }}</ref></noinclude><includeonly>See template.</includeonly>}}}}
+
| colspan="3" style="background-color:#eaecf0; text-align: center;" | {{noteslist|group=bic1}}
 
|}<!--
 
|}<!--
  

Latest revision as of 18:17, 19 December 2020

Major side effects of Template:No selflink[1][2][3][4][5][6][7]

Frequency Class of effect Effect
Very common (≥10%) Reproductive system and breast disorders  Breast tenderness[lower-alpha 1]
 Gynecomastia[lower-alpha 1]
Common (1-10%) General and psychiatric disorders  Asthenia
 Decreased libido
 Erectile dysfunction
 Hot flashes
Skin and subcutaneous
tissue disorders
 Decreased body hair
Hepato-biliary disorders  Elevated liver enzymes[lower-alpha 2]
Uncommon (0.1-1%) Immune system disorders and hypersensitivity reactions  Angioedema
 Hives
Rare (<0.1%) or unknown Respiratory disorders  Lung disease[lower-alpha 3]
Skin and subcutaneous tissue disorders  Sensitivity to light
Hepato-biliary disorders  Liver toxicity[lower-alpha 3]
Template:Noteslist
Template documentation

References

  1. Mcleod DG (September 2002). "Emerging role of adjuvant hormonal therapy". Urology. 60 (3 Suppl 1): 13–20, discussion 21. doi:10.1016/S0090-4295(02)01562-5. PMID 12231039.
  2. https://pdf.hres.ca/dpd_pm/00009096.PDF
  3. Bennett CL, Raisch DW, Sartor O (October 2002). "Pneumonitis associated with nonsteroidal antiandrogens: presumptive evidence of a class effect". Annals of Internal Medicine. 137 (7): 625. doi:10.7326/0003-4819-137-7-200210010-00029. PMID 12353966. An estimated 0.77% of the 6,480 nilutamide-treated patients, 0.04% of the 41,700 flutamide-treated patients, and 0.01% of the 86,800 bicalutamide-treated patients developed pneumonitis during the study period.
  4. Molina Mancero, Guillermo; Picón, Xavier; Di Tullio, Fernando; Ernst, Glenda; Dezanzo, Pablo; Salvado, Alejandro; Chertcoff, Julio F (2016). "Neumonía intersticial inducida por bloqueo androgénico máximo como tratamiento de cáncer de próstata avanzado" [Fatal interstitial lung disease associated with maximum androgen blockade. Report of one case]. Revista médica de Chile. 144 (10): 1356–1359. doi:10.4067/S0034-98872016001000017. ISSN 0034-9887.
  5. Lee K, Oda Y, Sakaguchi M, Yamamoto A, Nishigori C (May 2016). "Drug-induced photosensitivity to bicalutamide - case report and review of the literature". Photodermatol Photoimmunol Photomed. 32 (3): 161–4. doi:10.1111/phpp.12230. PMID 26663090.
  6. Gretarsdottir, Helga M.; Bjornsdottir, Elin; Bjornsson, Einar S. (2018). "Bicalutamide-Associated Acute Liver Injury and Migratory Arthralgia: A Rare but Clinically Important Adverse Effect". Case Reports in Gastroenterology. 12 (2): 266–270. doi:10.1159/000485175. ISSN 1662-0631.
  7. Anderson J (March 2003). "The role of antiandrogen monotherapy in the treatment of prostate cancer". BJU Int. 91 (5): 455–61. doi:10.1046/j.1464-410X.2003.04026.x. PMID 12603397. S2CID 8639102.


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