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

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Revision as of 02:56, 11 November 2018

Major side effects of bicalutamide alone

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

  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. 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.
  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.