Difference between revisions of "Template:Major side effects of bicalutamide alone"
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| − | |+ {{Resize|105%|Major side effects of bicalutamide alone}} | + | |+ {{Navbar|Major side effects of bicalutamide alone|mini=y}} {{Resize|105%|Major side effects of bicalutamide alone}} |
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! Frequency !! [[System Organ Class|Class]] !! [[Side effect]] | ! Frequency !! [[System Organ Class|Class]] !! [[Side effect]] | ||
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| [[Hepato-biliary disorder]]s || • [[Hepatotoxicity|Liver toxicity]]<sup>d</sup> | | [[Hepato-biliary disorder]]s || • [[Hepatotoxicity|Liver toxicity]]<sup>d</sup> | ||
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| − | | colspan="3" style="width: 1px;" | {{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 (150 mg/day) 4,000-patient trial.<br /><sup>c</sup> = Six case reports of interstitial lung disease published (as of 2016). Incidence of 0.01% (12 patients) in an 87,000-patient cohort.<br /><sup>d</sup> = Five case reports of hepatotoxicity published (as of 2016). No cases in a high-dose (150 mg/day) 4,000-patient trial (incidence of <0.03%).<br / | + | | colspan="3" style="width: 1px;" | {{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 (150 mg/day) 4,000-patient trial.<br /><sup>c</sup> = Six case reports of interstitial lung disease published (as of 2016). Incidence of 0.01% (12 patients) in an 87,000-patient cohort.<br /><sup>d</sup> = Five case reports of hepatotoxicity published (as of 2016). No cases in a high-dose (150 mg/day) 4,000-patient trial (incidence of <0.03%).<br />''Sources:'' <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 name="pmid27099451">{{cite journal | vauthors = Yun GY, Kim SH, Kim SW, Joo JS, Kim JS, Lee ES, Lee BS, Kang SH, Moon HS, Sung JK, Lee HY, Kim KH | title = Atypical onset of bicalutamide-induced liver injury | journal = World J. Gastroenterol. | volume = 22 | issue = 15 | pages = 4062–5 | date = April 2016 | pmid = 27099451 | pmc = 4823258 | doi = 10.3748/wjg.v22.i15.4062 | url = }}</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>}} |
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Revision as of 02:29, 11 November 2018
| Frequency | Class | Side effect |
|---|---|---|
| Very common (≥10%) |
Reproductive system and breast disorders |
• Breast tendernessa • Gynecomastiaa |
| Common (≥1% and <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 enzymesb | |
| Uncommon (≥0.1% and <1%) |
Immune system disorders | • Hypersensitivity reactions, including angioedema and hives |
| Rare (<0.1%) and unknown |
Respiratory, thoracic, and mediastinal disorders |
• Interstitial lung diseasec |
| Skin and subcutaneous tissue disorders |
• Sensitivity to light | |
| Hepato-biliary disorders | • Liver toxicityd | |
Footnotes and sources
a = Incidence of breast changes of up to 80 to 90%. Mild-to-moderate in 90% of cases. Incidence greatly decreased in combination with castration. b = 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 (150 mg/day) 4,000-patient trial. c = Six case reports of interstitial lung disease published (as of 2016). Incidence of 0.01% (12 patients) in an 87,000-patient cohort. d = Five case reports of hepatotoxicity published (as of 2016). No cases in a high-dose (150 mg/day) 4,000-patient trial (incidence of <0.03%). Sources: [1][2][3][4][5][6][7] | ||
References
- ↑ 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.
- ↑ https://pdf.hres.ca/dpd_pm/00009096.PDF
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ Yun GY, Kim SH, Kim SW, Joo JS, Kim JS, Lee ES, Lee BS, Kang SH, Moon HS, Sung JK, Lee HY, Kim KH (April 2016). "Atypical onset of bicalutamide-induced liver injury". World J. Gastroenterol. 22 (15): 4062–5. doi:10.3748/wjg.v22.i15.4062. PMC 4823258. PMID 27099451.
- ↑ 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.