Thalidomide

BreastfeedingPediatric
CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:

Alcohol, Amiodarone, Antihistamines, Antipsychotics, Bortezomib, Calcium channel blockers, Carbamazepine, Cimetidine, Cisplatin, CNS depressants, Digoxin, Disulfiram, Docetaxel, Famotidine, Griseofulvin, Lithium, Metronidazole, Modafinil, Opioids, Paclitaxel, Penicillins, Phenytoin, Rifabutin, Rifampin, St John's Wort, Succinylcholine, Vincristine

PREGNANCY CATEGORY: X

Under investigation for treating COVID-19

See adverse reactions attributed to class:

Covid-19 putative drug

Immunosuppressant

Thalidomide is a potent teratogen, an agent that causes congenital malformations and developmental abnormalities if introduced during gestation. Some of these teratogenic side effects of thalidomide include fetal limb growth retardation (arms, legs, hands, feet), ingrown genitalia, absence of lung, partial/total loss of hearing or sight, malformed digestive tract, heart, kidney, and stillborn infant.

FETAL RISK AND VENOUS THROMBOEMBOLIC EVENTS

See full prescribing information for complete boxed warning.

Acute generalized exanthematous pustulosis (AGEP) 

(2009): Momin SB+, Cutis 83(6), 291 (with dexamethasone and meloxicam)

Bullous dermatosis 5%

(1975): Sheskin J, Hautarzt (German) 26, 15%

Dermatitis 

(2017): He Y+, Therap Adv Gastroenterol 10(5), 3975%

(1971): Waters MFR, Lepr Rev 42, 26

Desquamation 

(2006): Olencki T+, Invest New Drugs 24(4), 321 (with interleukin-2)

Diaphoresis 13%

(1978): Smithells RW, Lancet 1, 1042

Edema (see also peripheral edema) 57%

(2011): Hus M+, Ann Hematol 90(10), 11615% (with dexamethasone)

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

(2006): Abgrall JF+, Haematologica 91(8), 1027

(2005): Moschella SL, Skinmed 4(1), 19

(2004): Strupp C+, Eur J Haematol 72(1), 52 (2 cases)

(2003): Hwu W-J, J Drugs Dermatol 2, 53 (with temozolomide)

(2000): Oliver SJ+, Clin Immunol 97(2), 109

(1997): Duran McKinster C, Skin and Allergy News August, 37

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

(1989): Grinspan D+, J Am Acad Dermatol 20, 1060

(1984): Gutierrez-Rodriguez O, Arthritis Rheum 27, 1118

Erythema 

(2005): Moschella SL, Skinmed 4(1), 19

(1989): Gutierrez-Rodriguez O+, J Rheumatol 16, 158

Erythema multiforme 

(2003): Hall VC+, J Am Acad Dermatol 48(4), 548 (3 cases) (with dexamethasone)

Erythema nodosum 

(1994): Gardner-Medwin JM+, Ann Rheum Dis 53(12), 828

(1988): Viraben R+, Dermatologica 176, 107

Erythroderma 

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

(1994): Bielsa I+, Dermatology (Basel) 189(2), 179

Exanthems 

(2000): Camisa C+, Arch Dermatol 136, 1442

(1991): Williams I+, Lancet 337, 43637% (in AIDS)

Exfoliative dermatitis 

(2005): Patt YZ+, Cancer 103(4), 749

(2003): Hall VC+, J Am Acad Dermatol 48(4), 548 (3 cases) (with dexamethasone)

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

(1988): Salafia A+, Int J Lepr Other Mycobact Dis 56, 625

Facial erythema <5%

(1989): Gutierrez-Rodriguez O+, J Rheumatol 16, 158

(1975): Sheskin J, Hautarzt (German) 26, 1

Hypersensitivity 

(2011): Hus M+, Ann Hematol 90(10), 11615% (with dexamethasone)

(2005): Moschella SL, Skinmed 4(1), 19

(2002): Kane S+, J Clin Gastroenterol 35(2), 149

Nodular eruption 

(2000): Bahl S+, Skin and Aging, May, 41

Palmar erythema 

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

Peripheral edema (see also edema) 3–8%

(2016): Mateos MV+, Br J Haematol 175(3), 44825% (grade 3+) (with dexamethasone and elotuzumab)

(2008): Mehta V, Indian J Lepr 80(4), 345

(2000): Camisa C+, Arch Dermatol 136, 1442

(1994): Gardner-Medwin JM+, Ann Rheum Dis 53(12), 828

Pruritus (itching) 3–8%

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

(1989): Gutierrez-Rodriguez O+, J Rheumatol 16, 158

Psoriasis 

(2006): Varma K+, Br J Dermatol 154(4), 789

(2003): Dobson CM+, Br J Dermatol 149(2), 432

Purpura 

(2005): Moschella SL, Skinmed 4(1), 19

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

Rash 11–50%

(2021): Panda PK+, Am J Trop Med Hyg Jul, Online ahead of print [REVIEW]10%

(2021): Tirado-Sánchez A+, Australas J Dermatol Mar, Online ahead of print4%

(2018): Li CS+, Zhongguo Shi Yan Xue Ye Xue Za Zhi 26(3), 836 (with dexamethasone and bortezomib)

(2014): Laubach JP+, Expert Rev Hematol 7(1), 97 [REVIEW]

(2014): Wang YS+, Sichuan Da Xue Xue Bao Yi Xue Ban (Chinese) 45(3), 52967% (with bortezomib and dexamethasone)

(2010): Agata M+, Rinsho Ketsueki 51 (3), 18930%

(2010): Gilbert MR+, Neuro Oncol 12(11), 1167 (with temozolomide in combination with isotretinoin)

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

(2006): Bringhen S+, Expert Opin Investig Drugs 15(12), 1565 [REVIEW]

(2006): Olencki T+, Invest New Drugs 24(4), 321 (with interleukin-2)

(2005): Patt YZ+, Cancer 103(4), 74920%

(2004): Wang TE+, World J Gastroenterol 10(5), 649

(2003): Hwu W-J, J Drugs Dermatol 2, 53 (with temozolomide)

(2003): Matthews SJ+, Clin Ther 25(2), 342 [REVIEW]

(2003): Okafor MC, Pharmacotherapy 23(4), 481 [REVIEW]

(2002): Baughman RP+, Chest 122(1), 227

(2002): Steins MB+, Blood 99(3), 834

(2002): Tosi P+, Haematologica 87(4), 40811%

(2001): Rajkumar SV, Oncology (Huntingt) 15(7), 867 [REVIEW]

(2001): Singhal S+, BioDrugs 15(3), 163 [REVIEW]30%

(2000): Oliver SJ+, Clin Immunol 97(2), 109

(2000): Rajkumar SV, Oncology (Huntingt) 14(12), 11 [REVIEW]

(1997): Haslett P+, Infect Med 14, 393

(1997): Jacobson JM+, New Engl J Med 336, 1487>>50%

(1994): Gardner-Medwin JM+, Ann Rheum Dis 53(12), 828

(1993): Holm AL+, Arch Dermatol 129, 1548 (passim)

(1986): Hamza MH, Clin Rheumatol 5, 365

Septic–toxic shock 

(2017): Kwon J+, Cancer Med 6(1), 100 (fatal / 2 cases)Fatal (with cyclophosphamide and dexamethasone)

Stevens-Johnson syndrome 

(2018): Fakoya AOJ+, Open Access Maced J Med Sci 6(4), 730 [REVIEW]

(2008): Tebruegge M+, AIDS Read 18(10), 519

(2001): Clark TE+, Drug Saf 24(2), 87 [REVIEW]

Toxic epidermal necrolysis 

(2003): Hall VC+, J Am Acad Dermatol 48(4), 548 (3 cases) (with dexamethasone)

(2001): Diggle GE, Int J Clin Pract 55(9), 627 [REVIEW]

(2000): Rajkumar SV+, N Engl J Med 343(13), 972

(1999): Horowitz SB+, Pharmacotherapy 19, 1177

Toxic pustuloderma 

(1997): Darvay A+, Clin Exp Dermatol 22, 297

Ulcerations 

(2001): Schlossberg H+, Bone Marrow Transplant 27, 229 (serious)

Urticaria / hives 3%

(2005): Moschella SL, Skinmed 4(1), 19

(1975): Sheskin J, Hautarzt (German) 26, 13%

Vasculitis (angiitis) / cutaneous vasculitis (angiitis) 

(2007): Yildirim ND+, Jpn J Clin Oncol 37(9), 704

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

Xerosis 21%

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

(2002): Bariol C+, J Gastroenterol Hepatol 17(2), 135

(2000): Bahl S+, Skin and Aging May, 41

(2000): Oliver SJ+, Clin Immunol 97(2), 109

(1989): Gutierrez-Rodriguez O+, J Rheumatol 16, 158

Dandruff 

(2021): Zhang S+, Ann Palliat Med Jan, Online ahead of print20%

Brittle nails 

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

Oral candidiasis 4–11%

(package insert)

Xerostomia (dry mouth) 8%

(2021): Zhang S+, Ann Palliat Med Jan, Online ahead of print23%

(2017): Zhang L+, J Clin Oncol 35(31), 3558

(2002): Bariol C+, J Gastroenterol Hepatol 17(2), 135

(2000): Bahl S+, Skin and Aging May, 41

(1999): Monastirli A+, Skin Pharmacol Appl Skin Physiol 12(6), 305

(1996): Huizinga TW+, Ann Rheum Dis 55(11), 833

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

(1994): Gardener-Merwin JM+, Ann Rheum Dis 53, 828

(1989): Grinspan D+, J Am Acad Dermatol 20, 1060

(1989): Gutierrez-Rodriguez O+, J Rheumatol 16, 158

Atrioventricular block 

(2006): Hinterseer M+, Clin Res Cardiol 95(9), 474

Bradycardia / sinus bradycardia 

(2015): Okamura I+, Rinsho Ketsueki 56(1), 38

(2011): Hus M+, Ann Hematol 90(10), 11615% (with dexamethasone)

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

(2006): Durk HA, Onkologie 29(12), 582 [REVIEW]

(2005): Moschella SL, Skinmed 4(1), 19

Cardiotoxicity 

(2017): Bringhen S+, Clin Lymphoma Myeloma Leuk 17(7), 391 [REVIEW]

(2014): Palumbo A+, J Clin Oncol 32(7), 63411% (grade 3 or 4) (with bortezomib, melphalan and prednisone)

Hypotension 16%

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

Myocardial ischemia 

(2007): Martino M+, Eur J Haematol 78 (1), 35 (3 cases)

Postural hypotension 

(2017): Kwon J+, Cancer Med 6(1), 10012% (with an alkylating agent and steroid)

Tachycardia 

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

Thromboembolism 

(2017): Bringhen S+, Clin Lymphoma Myeloma Leuk 17(7), 391 [REVIEW]

(2011): Hus M+, Ann Hematol 90(10), 11615% (with dexamethasone)

Venous thromboembolism 

(2017): Kaur U+, Curr Drug Saf May, Epub ahead of print

(2017): Kwon J+, Cancer Med 6(1), 1002% (with an alkylating agent and steroid)

(2014): Huang H+, Leuk Res 38(9), 1048 [REVIEW]

(2012): Ipek Y+, J Thromb Thrombolysis 33(2), 197 [REVIEW]

(2010): Hurteau JA+, Gynecol Oncol 119(3), 4446% (grade 3 or 4)

Agitation 9–26%

(2007): Lazzerini M+, Aliment Pharmacol Ther 25(4), 419

Chills 

(2006): Olencki T+, Invest New Drugs 24(4), 321 (with interleukin-2)

Dysesthesia 

(1989): Grinspan D+, J Am Acad Dermatol 20, 1060

Fever (pyrexia) 19–23%

(2011): Hus M+, Ann Hematol 90(10), 11612% (with dexamethasone)

(2006): Olencki T+, Invest New Drugs 24(4), 321 (with interleukin-2)

Hallucinations 

(2007): Lazzerini M+, Aliment Pharmacol Ther 25(4), 419

Headache 

(2021): Tirado-Sánchez A+, Australas J Dermatol Mar, Online ahead of print24%

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

Hyperesthesia 

(2010): Agata M+, Rinsho Ketsueki 51 (3), 18948%

(2000): Bahl S+, Skin and Aging, May, 41

Insomnia 9%

(2021): Tirado-Sánchez A+, Australas J Dermatol Mar, Online ahead of print7%

Mood changes 

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

Neurotoxicity 22%

(2017): He Y+, Therap Adv Gastroenterol 10(5), 39721%

(2017): Seng BJJ+, Int J Artif Organs 40(11), 636

(2016): Bramuzzo M+, Medicine (Baltimore) 95(30), Epub [REVIEW]64%

(2015): Mancano MA, Hosp Pharm 50(1), 13 (orofacial)

(2014): Leiba M+, Br J Haematol 166(5), 702 [REVIEW]11% (grade 3 or 4) (with bortezomib and dexamethasone)

(2014): Soffietti R+, Handb Clin Neurol 121, 1199 [REVIEW]

(2012): Moehler T, Curr Cancer Drug Targets 12(4), 372 [REVIEW]

(2011): Hus M+, Ann Hematol 90(10), 116124% (with dexamethasone)

(2008): Durrieu G+, Presse Med (French) 37(6 Pt 1), 935 (57 cases)

(2006): Chan JK+, Gynecol Oncol 103(3), 91971%

(2006): Durk HA, Onkologie 29(12), 582 [REVIEW]

(2005): Cuadrado MJ+, Am J Med 118(3), 24627%

(2005): Fleming FJ+, Neuromuscul Disord 15(2), 172 (4 cases)

(2005): Moschella SL, Skinmed 4(1), 19

(2005): Tosi P+, Eur J Haematol 74(3), 21275%

(2004): Briani C+, Neurology 62(12), 2288

(2004): Offidani M+, Eur J Haematol 72(6), 40339%

(2004): Strupp C+, Eur J Haematol 72(1), 52 (2 cases)

(2004): Wang TE+, World J Gastroenterol 10(5), 649

(2003): Foldyna D+, Vnitr Lek 49(11), 85941%

(2003): Matthews SJ+, Clin Ther 25(2), 342 [REVIEW]

(2003): Okafor MC, Pharmacotherapy 23(4), 481 [REVIEW]

(2002): Grover JK+, Ann Oncol 13(10), 1636

(1992): Awofeso N, Trop Doct 22(3), 139

Paresthesias 6–16%

(2021): Tirado-Sánchez A+, Australas J Dermatol Mar, Online ahead of print9%

(2005): Moschella SL, Skinmed 4(1), 19

(2005): Tosi P+, Eur J Haematol 74(3), 212

(2004): Nguyen YT+, J Am Acad Dermatol A(2), 235

(2002): Baughman RP+, Chest 122(1), 227

(2000): Bahl S+, Skin and Aging, May, 41

(2000): Ordi-Ros J+, J Rheumatol 27, 1429

(1999): Duong DJ, Arch Dermatol 135, 1079

(1998): Lee JB+, J Am Acad Dermatol 39, 835

Parkinsonism 

(2009): Crystal SC+, Mov Disord 24(12), 1863

(2008): Alvarez MV+, Neurology 70(8), e32

Peripheral neuropathy 

(2021): Panda PK+, Am J Trop Med Hyg Jul, Online ahead of print [REVIEW]6%

(2019): Buscarini E+, Orphanet J Rare Dis 14(1)18% (with bevacizumab)

(2018): Iida S+, Cancer Sci Feb, Epub ahead of print9% (grade 3 or 4) (with dexamethasone)

(2018): Li CS+, Zhongguo Shi Yan Xue Ye Xue Za Zhi 26(3), 836 (with dexamethasone and bortezomib)

(2017): Bramuzzo M+, Inflamm Bowel Dis 23(10), 181042%Pediatric

(2017): Bringhen S+, Clin Lymphoma Myeloma Leuk 17(7), 391 [REVIEW] (exacerbation)

(2017): Holmberg LA+, Acta Haematol 137(3), 123 (with clarithromycin and dexamethasone)

(2017): Kaur U+, Curr Drug Saf May, Epub ahead of print (passim)

(2017): Kwon J+, Cancer Med 6(1), 10029% (with an alkylating agent and steroid)

(2016): Castro TB+, Braz J Med Biol Res 49(6), e512868%

(2016): Wang Y+, J Natl Cancer Inst 108(3), Epub [REVIEW]

(2015): Lazzerini M+, Inflamm Bowel Dis 21(8), 1739Pediatric

(2015): Morawska M+, Hematol Oncol 33(4), 113

(2014): Garcia MK+, J Hematol Oncol 7(1), 41

(2014): Huang H+, Leuk Res 38(9), 1048 [REVIEW]

(2014): Laubach JP+, Expert Rev Hematol 7(1), 97 [REVIEW]

(2014): Palumbo A+, J Clin Oncol 32(7), 63411% (grade 3 or 4) (with bortezomib, melphalan and prednisone)

(2014): Wang YS+, Sichuan Da Xue Xue Bao Yi Xue Ban (Chinese) 45(3), 5297% (grade 3) (with bortezomib and dexamethasone)

(2013): Gruson B+, Br J Haematol 161(3), 43411%

(2012): Mateos MV, Leuk Res 36 Suppl 1, S35 [REVIEW]

(2010): Hurteau JA+, Gynecol Oncol 119(3), 4446% (grade 3 or 4)

(2007): Martino M+, Eur J Haematol 78(1), 35 (2 cases)

(2007): Prince HM+, Leuk Lymphoma 48(1), 46

(2006): Bringhen S+, Expert Opin Investig Drugs 15(12), 1565 [REVIEW]70%

(2006): Doss DS, Clin J Oncol Nurs 10(4), 514 [REVIEW] (with dexamethasone)

(2006): Lyakhovisky A+, Harefuah 145(7), 489 (2 cases)

(2006): Mileshkin L+, Leuk Lymphoma 47(11), 2276

(2006): Mileshkin L+, J Clin Oncol 24(27), 450741%

(2006): Rose MI+, Plast Reconstr Surg 117(7), 2329

(2000): Walchner M+, Int J Dermatol 39(5), 383

Sedation  

(2017): Zhang L+, J Clin Oncol 35(31), 3558

Seizures 

(2005): Moschella SL, Skinmed 4(1), 19

Somnolence (drowsiness) 36%

(2021): Zhang S+, Ann Palliat Med Jan, Online ahead of print29%

(2019): Buscarini E+, Orphanet J Rare Dis 14(1)12% (with bevacizumab)

(2018): Li Y+, Aging Clin Exp Res 30(5), 499 (with capecitabine)

(2017): He Y+, Therap Adv Gastroenterol 10(5), 39726%

(2017): Kwon J+, Cancer Med 6(1), 10030% (with an alkylating agent and steroid)

(2017): Seng BJJ+, Int J Artif Organs 40(11), 636

(2014): Laubach JP+, Expert Rev Hematol 7(1), 97 [REVIEW]

(2012): Moehler T, Curr Cancer Drug Targets 12(4), 372 [REVIEW]

(2011): Hus M+, Ann Hematol 90(10), 116110% (with dexamethasone)

(2010): Hurteau JA+, Gynecol Oncol 119(3), 44412% (grade 3 or 4)

(2010): Valente Mdo S+, Rev Soc Bras Med Trop 43 (2), 201

(2007): Lazzerini M+, Aliment Pharmacol Ther 25(4), 419

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

(2003): Matthews SJ+, Clin Ther 25(2), 342 [REVIEW]

(2002): Ciepluch H+, Med Sci Monit 8(4), PI31

Tremor 4–26%

(2017): He Y+, Therap Adv Gastroenterol 10(5), 3972%

(2015): Zadori D+, Expert Opin Drug Saf 14(6), 877 [REVIEW]

(2005): Chiruka S+, Am J Hematol 78(1), 81

(2005): Tosi P+, Eur J Haematol 74(3), 212

(2003): Hwu W-J, J Drugs Dermatol 2, 53 (with temozolomide)

(1999): Duong DJ+, Arch Dermatol 135(9), 1079

Vertigo / dizziness 4–20%

(2021): Zhang S+, Ann Palliat Med Jan, Online ahead of print11%

(2019): Buscarini E+, Orphanet J Rare Dis 14(1)9% (with bevacizumab)

(2017): He Y+, Therap Adv Gastroenterol 10(5), 3975%

(2017): Kwon J+, Cancer Med 6(1), 10012% (with an alkylating agent and steroid)

(2017): Zhang L+, J Clin Oncol 35(31), 3558

(2014): Laubach JP+, Expert Rev Hematol 7(1), 97 [REVIEW]

(2012): Horton MR+, Ann Intern Med 157(6), 398

(2011): Hus M+, Ann Hematol 90(10), 116110% (with dexamethasone)

(2010): Valente Mdo S+, Rev Soc Bras Med Trop 43 (2), 201

(2007): Lazzerini M+, Aliment Pharmacol Ther 25(4), 419

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

(2006): Durk HA, Onkologie 29(12), 582 [REVIEW]

(2005): Moschella SL, Skinmed 4(1), 19

(2005): Tosi P+, Eur J Haematol 74(3), 212

(2003): Foldyna D+, Vnitr Lek 49(11), 85947%

(2002): Baughman RP+, Chest 122(1), 227

(2002): Ciepluch H+, Med Sci Monit 8(4), PI31

(2002): Crouch RB+, Australas J Dermatol 43(4), 278

Amenorrhea 

(2015): Lazzerini M+, Inflamm Bowel Dis 21(8), 1739

(2004): Dharia SP+, Fertil Steril 82(2), 460 [REVIEW]

(2002): Frances C+, Eur J Dermatol 12(1), 63

(2001): Passeron T+, Br J Dermatol 144(6), 1292 (2 cases)

(1999): Gompel A+, Arthritis Rheum 42(10), 2259

(1998): Ordi J+, Arthritis Rheum 41(12), 2273

Appetite increased 

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

Galactorrhea 

(1996): Tseng S+, J Am Acad Dermatol 35, 969 [REVIEW] (passim)

Gynecomastia 

(2003): Mourad YA+, Hematol J 4(5), 372

(2002): Pulik M+, Am J Hematol 70(3), 265

Hypertransaminasemia (transaminitis) / elevated transaminases 

(2021): Panda PK+, Am J Trop Med Hyg Jul, Online ahead of print [REVIEW]10%

Hypothyroidism 

(2015): Okamura I+, Rinsho Ketsueki 56(1), 38

Menstrual irregularities 

(2017): He Y+, Therap Adv Gastroenterol 10(5), 3972%

Thyroid dysfunction 

(2011): Hamnvik OP+, J Natl Cancer Inst 103(21), 1572 [REVIEW]

Weight gain 22%

(2021): Tirado-Sánchez A+, Australas J Dermatol Mar, Online ahead of print3%

Weight loss 23%

(package insert)

Abdominal pain 3%

(2005): Cuadrado MJ+, Am J Med 118(3), 246

Constipation 

(2021): Tirado-Sánchez A+, Australas J Dermatol Mar, Online ahead of print4%

(2021): Zhang S+, Ann Palliat Med Jan, Online ahead of print23%

(2018): Li Y+, Aging Clin Exp Res 30(5), 499 (with capecitabine)

(2017): He Y+, Therap Adv Gastroenterol 10(5), 39726%

(2017): Kaur U+, Curr Drug Saf May, Epub ahead of print (passim)

(2017): Seng BJJ+, Int J Artif Organs 40(11), 636

(2017): Zhang L+, J Clin Oncol 35(31), 3558

(2016): Castro TB+, Braz J Med Biol Res 49(6), e512847%

(2015): Okamura I+, Rinsho Ketsueki 56(1), 38

(2014): Laubach JP+, Expert Rev Hematol 7(1), 97 [REVIEW]

(2012): Horton MR+, Ann Intern Med 157(6), 398

(2012): Moehler T, Curr Cancer Drug Targets 12(4), 372 [REVIEW]

(2011): Hus M+, Ann Hematol 90(10), 116114% (with dexamethasone)

(2010): Agata M+, Rinsho Ketsueki 51 (3), 18933%

(2002): Ciepluch H+, Med Sci Monit 8(4), PI31

Diarrhea 4–19%

(package insert)

Flatulence 8%

(package insert)

Hepatitis 

(2012): Vilas-Boas F+, Gastroenterol Hepatol 35(8), 560

Hepatotoxicity / liver injury / acute liver injury / drug-induced liver injury (DILI) 

(2017): He Y+, Therap Adv Gastroenterol 10(5), 3975%

(2017): Seng BJJ+, Int J Artif Organs 40(11), 636

(2015): Huang XE+, Asian Pac J Cancer Prev 16(17), 7867 (1 case) (with chemotherapy)

(2006): Hanje AJ+, Pharmacotherapy 26(7), 1018

Nausea 

(2011): Hus M+, Ann Hematol 90(10), 11615% (with dexamethasone)

Pancreatitis / acute pancreatitis 

(2008): Chung LW+, Ann Hematol 87(5), 421

(2002): Rajkumar SV+, J Clin Oncol 20(21), 4319

Vomiting  

(2011): Hus M+, Ann Hematol 90(10), 11612% (with dexamethasone)

Erectile dysfunction 

(2007): Martino M+, Eur J Haematol 78(1), 35

(2007): Rosenbach M+, Dermatol Ther 20(4), 175 (passim)

Impotence 38%

(2007): Murphy PT+, Haematologica 92(10), 1440

Leukorrhea  17–35%

(package insert)

Anemia 6–13%

(2018): Li CS+, Zhongguo Shi Yan Xue Ye Xue Za Zhi 26(3), 836 (with dexamethasone and bortezomib)

(2017): Kwon J+, Cancer Med 6(1), 1008% (with an alkylating agent and steroid)

(2017): Lu J+, Br J Haematol 176(5), 74315% (grade 3 or 4) (with melphalan and prednisone)

(2014): Huang H+, Leuk Res 38(9), 1048 [REVIEW]

(2013): Nooka AK, Oncology (Williston Park) 27 Suppl 3, 11 [REVIEW] (passim)

Granulocytopenia 

(2018): Li CS+, Zhongguo Shi Yan Xue Ye Xue Za Zhi 26(3), 836 (with dexamethasone and bortezomib)

Myelosuppression / bone marrow suppression / myelotoxicity 

(2015): Huang XE+, Asian Pac J Cancer Prev 16(17), 7867 (1 case) (with chemotherapy)

Neutropenia (neutrophils decreased) 31%

(2017): Kwon J+, Cancer Med 6(1), 10012% (with an alkylating agent and steroid)

(2017): Lu J+, Br J Haematol 176(5), 74344% (grade 3 or 4) (with melphalan and prednisone)

(2016): Castro TB+, Braz J Med Biol Res 49(6), e512832%

(2014): Huang H+, Leuk Res 38(9), 1048 [REVIEW]

(2014): Palumbo A+, J Clin Oncol 32(7), 63438% (grade 3 or 4) (with bortezomib, melphalan and prednisone)

(2013): Gruson B+, Br J Haematol 161(3), 4345%

(2013): Nooka AK, Oncology (Williston Park) 27 Suppl 3, 11 [REVIEW] (passim)

(2012): Offidani M+, Leuk Lymphoma 53(9), 172271% (grade 3 or 4) (with melphalan, panobinostat and prednisone)

(2010): Gilbert MR+, Neuro Oncol 12(11), 1167 (with temozolomide in combination with isotretinoin and celecoxib)

Sepsis 

(2012): Teoh G+, Clin Lymphoma Myeloma Leuk 12(2), 118 (with dexamethasone and zoledronic acid)

Thrombocytopenia 

(2017): Kwon J+, Cancer Med 6(1), 1005% (with an alkylating agent and steroid)

(2014): Huang H+, Leuk Res 38(9), 1048 [REVIEW]

(2014): Palumbo A+, J Clin Oncol 32(7), 63422% (grade 3 or 4) (with bortezomib, melphalan and prednisone)

(2013): Gruson B+, Br J Haematol 161(3), 43411%

(2013): Nooka AK, Oncology (Williston Park) 27 Suppl 3, 11 [REVIEW] (passim)

(2012): Offidani M+, Leuk Lymphoma 53(9), 172236% (grade 3 or 4) (with melphalan, panobinostat and prednisone)

Thrombosis 

(2017): Seng BJJ+, Int J Artif Organs 40(11), 636

(2010): Gilbert MR+, Neuro Oncol 12(11), 1167 (with temozolomide in combination with isotretinoin)

(2009): Fabi SG+, J Drugs Dermatol 8(8), 765 [REVIEW]

(2007): Prince HM+, Leuk Lymphoma 48(1), 463%

(2006): Anscher MS+, Int J Radiat Oncol Biol Phys 66(2), 477

(2006): Bennett CL+, JAMA 296(21), 2558 [REVIEW]

(2006): Bringhen S+, Expert Opin Investig Drugs 15(12), 1565 [REVIEW]

(2006): Doss DS, Clin J Oncol Nurs 10(4), 514 [REVIEW] (with dexamethasone)

(2006): Durk HA, Onkologie 29(12), 582 [REVIEW]

(2006): Harousseau JL, Future Oncol 2(5), 577 [REVIEW] (with dexamethasone)

(2006): Ikhlaque N+, Am J Hematol 81(6), 420

(2006): Miller KC+, Leuk Lymphoma 47(11), 2339

(2006): Olencki T+, Invest New Drugs 24(4), 321 (with interleukin-2)

Infusion-related reactions 

(2016): Mateos MV+, Br J Haematol 175(3), 44815% (with dexamethasone and elotuzumab)

Arthralgia 13%

(package insert)

Asthenia / fatigue 79%

(2021): Tirado-Sánchez A+, Australas J Dermatol Mar, Online ahead of print19%

(2018): Li CS+, Zhongguo Shi Yan Xue Ye Xue Za Zhi 26(3), 836 (with dexamethasone and bortezomib )

(2018): Li Y+, Aging Clin Exp Res 30(5), 499 (with capecitabine)

(2017): He Y+, Therap Adv Gastroenterol 10(5), 3972%

(2017): Kwon J+, Cancer Med 6(1), 10030% (with an alkylating agent and steroid)

(2016): Mateos MV+, Br J Haematol 175(3), 44835% (grade 3+) (with dexamethasone and elotuzumab)

(2015): Okamura I+, Rinsho Ketsueki 56(1), 38

(2014): Laubach JP+, Expert Rev Hematol 7(1), 97

(2012): Horton MR+, Ann Intern Med 157(6), 398

(2011): Hus M+, Ann Hematol 90(10), 116119% (with dexamethasone)

(2010): Gilbert MR+, Neuro Oncol 12(11), 1167 (with temozolomide in combination with isotretinoin)

(2007): Martino M+, Eur J Haematol 78(1), 35 (2 cases)

(2006): Bringhen S+, Expert Opin Investig Drugs 15(12), 1565 [REVIEW]

(2006): Chan JK+, Gynecol Oncol 103(3), 91965%

(2006): Olencki T+, Invest New Drugs 24(4), 321 (with interleukin-2)

(2005): Lin AY+, Cancer 103(1), 11981%

(2004): Offidani M+, Eur J Haematol 72(6), 40320%

(2004): Strupp C+, Eur J Haematol 72(1), 52 (8 cases)

Lacrimation 

(2009): Miller MT+, Birth Defects Res A Clin Mol Teratol 85 (8), 667 ("crocodile tears")

Vision blurred 

(2017): He Y+, Therap Adv Gastroenterol 10(5), 3977%

Dyspnea / shortness of breath 42%

(package insert)

Flu-like syndrome 

(2006): Schrader AJ+, Aktuelle Urol 37(6), 429 (with interleukin-2)

Pharyngitis 4–8%

(package insert)

Pneumonia 

(2017): Kwon J+, Cancer Med 6(1), 100 (fatal / 1 case)Fatal (with cyclophosphamide and dexamethasone)

(2006): Feaver AA+, South Med J 99(11), 1292 (with dexamethasone)

Pulmonary hypertension 

(2018): McGee M+, Clin Toxicol (Phila) Mar, Epub ahead of print [REVIEW]

Pulmonary toxicity 

(2010): Hurteau JA+, Gynecol Oncol 119(3), 4449% (grade 3 or 4)

Rhinitis 4%

(package insert)

Sinusitis 3–8%

(package insert)

Adverse effects 

(2017): Kwon J+, Cancer Med 6(1), 10020% (gastrointestinal / with an alkylating agent and steroid)

(2015): Huang XE+, Asian Pac J Cancer Prev 16(17), 7867 (1 case) (gastrointestinal / with chemotherapy)

(2014): Huang H+, Leuk Res 38(9), 1048 [REVIEW] (gastrointestinal)

(2014): Leiba M+, Br J Haematol 166(5), 70251% (grade 3 or 4) (with bortezomib and dexamethasone)

(2013): Olivier-Abbal P+, Med Oncol 30(4), 733 [REVIEW]

(2012): Horton MR+, Ann Intern Med 157(6), 39874%

(2010): Hello M+, Medicine (Baltimore) 89 (3), 17684%

(2003): Okafor MC, Pharmacotherapy 23(4), 481 [REVIEW]

Allergic reactions 

(2011): Hus M+, Ann Hematol 90(10), 11615% (with dexamethasone)

Death 

(2017): Kwon J+, Cancer Med 6(1), 100 (3 cases) (with cyclophosphamide and dexamethasone)

(2001): Diggle GE, Int J Clin 55(9), 627 [REVIEW]

Infection 6–8%

(2017): Kwon J+, Cancer Med 6(1), 10017% (with an alkylating agent and steroid)

(2017): Lu J+, Br J Haematol 176(5), 74328% (grade 3 or 4) (with melphalan and prednisone)

(2014): Huang H+, Leuk Res 38(9), 1048 [REVIEW]

(2013): Nooka AK, Oncology (Williston Park) 27 Suppl 3, 11 [REVIEW] (passim)

(2007): Martino M+, Eur J Haematol 78(1), 35 (2 cases)

(2003): Hwu W-J, J Drugs Dermatol 2, 53 (with temozolomide)

Teratogenicity 

(2011): Knobloch J+, Curr Mol Pharmacol 4 (1), 26 (limb)

(2010): Ito T+, Science 327 (5971), 1345

(2010): Rafiee P+, Am J Physiol Gastrointest Liver Physiol 298(2), G167

(2008): Knobloch J+, Cell Cycle 7 (9), 1121 (limb defects)

(2006): Laffitte E, Rev Prat 56(18), 1977

(2005): Coelho A+, Lupus 14(6), 434

Toothache (odontalgia) 4%

(package insert)



Adverse reactions attributed to entire drug class Covid-19 putative drug

Cardiovascular adverse effect 

(2020): Carpenter A+, Front Cardiovasc Med 7, 85 [REVIEW]

(2020): Giudicessi JR+, Mayo Clin Proc May, Online ahead of print [REVIEW]

(2020): Naksuk N+, Eur Heart J Acute Cardiovasc Care May, Epub ahead of print [REVIEW]

(2020): Sarayani A+, Res Social Adm Pharm Apr, Epub ahead of print [REVIEW]

(2020): Zhang D+, Zhongguo Zhong Yao Za Zhi (Chinese) 45(10), 2275-2286 [REVIEW]

Neuropsychiatric / neuropsychological adverse effect 

(2021): Borah P+, Front Mol Biosci 8, 627723

(2020): García CAC+, Gen Hosp Psychiatry Jun, Online ahead of print [REVIEW]

Gastrointestinal disorder / discomfort 

(2020): Sun J+, Clin Pharmacol Ther Apr, Epub ahead of print23%

Hepatic (liver) disorder / hepatic (liver) dysfunction 

(2020): Sun J+, Clin Pharmacol Ther Apr, Epub ahead of print14%

Thrombocytopenia 

(2020): Nham E+, Infect Chemother Apr, Epub ahead of print

Adverse effects 

(2021): Bérard A+, PLoS One 16(5), e0251746 [REVIEW] (in pregnancy)

(2021): Cheng Q+, Aging (Albany NY) Sep, Online ahead of print [REVIEW]

(2021): Cruciani F+, Recenti Prog Med 112(3), 195-206 [REVIEW]

(2021): Ommati MM+, J Biochem Mol Toxicol May, Online ahead of print [REVIEW]

(2021): Qiu R+, Medicine (Baltimore) 100(16), e25532 [REVIEW]

(2021): Wu SS+, Chin Med J (Engl) Jul, Online ahead of print [REVIEW]

(2020): Favilli A+, J Matern Fetal Neonatal Med Jun, Online ahead of print [REVIEW]

(2020): Griffiths G+, Trials 21(1), 544

(2020): Patil VM+, Life Sci May, Epub ahead of print [REVIEW]

(2020): Rhodes NJ+, medRxiv Jun, Preprint

(2020): Sun J+, Clin Pharmacol Ther Apr, Epub ahead of print38%

(2020): Svensson M, Lakartidningen (Swedish) Apr, 117

(2020): Wen CY+, Zhonghua Nei Ke Za Zhi (Chinese) May, Epub ahead of print

(2020): Zekarias A+, Drug Saf Sep, Online ahead of print [REVIEW]

(2020): Zhong H+, Pharmacol Res Apr, Epub ahead of print [REVIEW]

Adverse reactions attributed to entire drug class Immunosuppressant

Adverse effects 

(2019): Zhang Z+, BMC Nephrol 20(1), 333 [REVIEW]

Page last updated 08/02/2021

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Incidence info

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  • 10-15%
  • 15-20%
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  • >30%

Seriousness info

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  • Life threatening
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