Azithromycin

BreastfeedingPediatric
  • TRADE NAMES: AzaSite (Merck); Azenil; Azitrocin; Azitromax; Zeto; Zithromax (Pfizer); Zitromax; Zmax
  • INDICATIONS: Infections of the upper and lower respiratory tract, skin infections, sexually transmitted diseases, conjunctivitis (ophthalmic preparations only)
  • CLASS: Antibacterial, Antibiotic; macrolide, COVID-19 putative drug
  • HALF-LIFE: 68 hours

See adverse reactions attributed to class:

Antibiotic; macrolide

COVID-19 putative drug

AzaSite is for topical ophthalmic use only (for reactions see [Ophth] below).

Acute generalized exanthematous pustulosis (AGEP) 

(2017): Campanon-Toro MV+, Contact Dermatitis 76(6), 363

(2015): da Cunha Filho RR+, Int J Dermatol 54(6), e247

(2012): Zweegers J+, Ned Tijdschr Geneeskd (Dutch) 156(46), a4613

Allergic granulomatous angiitis (Churg–Strauss syndrome) 

(1998): Dietz A+, Laryngorhinootologie 77(2), 111 (with roxithromycin)

(1997): Kranke B+, Lancet 350, 1551

Anaphylactoid reactions/Anaphylaxis 

(2014): Mori F+, Int J Immunopathol Pharmacol 27(1), 121Pediatric

(2008): Todisco T+, J Chemother 20(2), 225 (with ampicillin/sulbactam)

Angioedema <1%

(2008): Todisco T+, J Chemother 20(2), 225 (with ampicillin/sulbactam)

Candidiasis <1%

(package insert)

Contact dermatitis 

[Ophth]

(2007): Milkovic-Kraus S+, Contact Dermatitis 56 (2), 99

Dermatitis 

(2001): Milkovic-Kraus S+, Contact Dermatitis 45(3), 184

Diaper rash 

(1997): Arguedas A+, Infections in Medicine October, 807

DRESS syndrome 

(2016): Silva SA+, Rev Assoc Med Bras 62(3), 227 [REVIEW]

(2014): Sriratanaviriyakul N+, J Med Case Rep 8, 332 (with dextromethorphan and promethazine)

(2013): Schmutz JL+, Ann Dermatol Venereol (French) 140(1), 75Pediatric

(2011): Bauer KA+, Pediatr Dermatol 28(6), 741

Erythema 

(2003): Taylor WR+, Antimicrob Agents Chemother 47(7), 2199

(1991): Felstead SJ+, J Int Med Res 19, 363

Exanthems 

(2002): Dakdouki GK+, Scand J Infect Dis 34(12), 939

(2000): Nakayama I, Jpn J Antibiot 53 Suppl B, 82 (1 case)

(2000): Schissel DJ+, Cutis 65 (3), 163 (in a patient with infectious mononucleosis)

Hypersensitivity <1%

(2015): Barni S+, J Investig Allergol Clin Immunol 25(2), 128Pediatric

(2001): Cascaval RI+, Am J Med 110, 330

(1998): Salit IE+, Infect Med 15, 773

Jarisch–Herxheimer reaction 

(2012): Mutua FM+, Cochrane Database Syst Rev 8

(2003): Taylor WR+, Antimicrob Agents Chemother 47(7), 2199

Jaundice 

(2014): Begum B+, Mymensingh Med J 23(3), 441Pediatric

Linear IgA bullous dermatosis 

(2007): Cummings JE+, Cutis 79 (3), 203 (with rimantadine and zanamivir)

Photosensitivity 1%

(package insert)

Pruritus 

(2014): Sagara I+, Malar J 13(1), 458 (with chloroquine)

(2003): Taylor WR+, Antimicrob Agents Chemother 47(7), 2199

(2000): Schissel DJ+, Cutis 65 (3), 163 (in a patient with infectious mononucleosis)

Pustules 

(1994): Trevisi P+, Clin Exp Dermatol 19(3), 280

Rash 2–10%

[Ophth]

(2018): Oldenburg CE+, PLoS Negl Trop Dis 12(11)Pediatric

(2015): Abely M+, Rev Mal Respir (French) 32(6), 557

(2014): Banerjee I+, J Clin Diagn Res 8(8), HD01 [REVIEW]

(2002): Dakdouki GK+, Scand J Infect Dis 34(12), 939

(2000): Krause PJ+, N Engl J Med 343 (20), 14548% (with atovaquone)

(1991): Felstead SJ+, J Int Med Res 19, 363

(1991): Mallory SB, Am J Med 91(3A), 36S

Stevens-Johnson syndrome 

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

(2018): Xu L+, Medicine (Baltimore) 97(1), e9112 [REVIEW]Pediatric

(2017): Arantes LB+, An Bras Dermatol 92(5), 6615%

(2016): Nappe TM+, Am J Emerg Med 34(3), 676.e1

(2010): Juricic D+, Basic Clin Pharmacol Toxicol 106(1), 62

(2006): Brkljacic N+, Acta Dermatovenerol Croat 14(1), 40

(2005): Schmutz JL+, Ann Dermatol Venereol, 728

(2004): Aihara Y+, Allergy 59(1), 118

(2001): Brett AS+, South Med J 94, 342

Toxic epidermal necrolysis 

(2017): Arantes LB+, An Bras Dermatol 92(5), 6615%

Toxic pustuloderma 

(1994): Trevisi P+, Clin Exp Dermatol 19, 280

Toxicity 

(2000): Granowitz EV+, Pacing Clin Electrophysiol 23(9), 1433 (with disopyramide)

Urticaria 

[Ophth]

(2001): Thaler D, Monana, WI (from Internet / observation)

(1991): Mallory SB, Am J Med 91(3A), 36S

Vasculitis 

  • Vasculitis from azithromycin
  • Vasculitis from azithromycin
  • Vasculitis from azithromycin
  • Vasculitis from azithromycin

(2003): Odemis E+, J Rheumatol 30(10), 2292

Aphthous stomatitis 

(2019): Moghadam ET+, Curr Clin Pharmacol March, Epub ahead of print (3 cases)

Bradycardia 

(2017): Benn K+, Am J Case Rep 18, 883Pediatric

(2010): Santos N+, Rev Port Cardiol 29(1), 139

Cardiotoxicity 

(2014): Khan MS+, J Pak Med Assoc 64(2), 238 (fatal)Fatal

(2014): Maisch NM+, J Pharm Pract 27(5), 496 [REVIEW]

(2012): Med Lett Drugs Ther 54(1392), 45

(2012): Harv Heart Lett 22(12)

(2012): Albert RK+, N Engl J Med 367(8), 773

(2012): Knirsch CA+, N Engl J Med 367(8), 772

(2012): Louie R, N Engl J Med 367(8)

(2012): Pires dos Santos R+, N Engl J Med 367(8), 774

QT prolongation 

(2015): Chopra R+, Expert Opin Drug Saf 14(3), 401 [REVIEW]

(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW] (fatal)Fatal

(2014): Diezi L+, Rev Med Suisse (French) 10(412-413), 119 [REVIEW]

(2014): Maisch NM+, J Pharm Pract 27(5), 496 [REVIEW]

(2014): Tay KY+, Pharmacoepidemiol Drug Saf 23(1), 9

(2013): Howard PA, Ann Pharmacother 47(11), 1547 [REVIEW]

(2010): Guo D+, Pharmazie 65(9), 631 [REVIEW]

(2010): Santos N+, Rev Port Cardiol 29(1), 139

(2007): Huang BH+, Pacing Clin Electrophysiol 30 (12), 1579

(2006): Russo V+, Acta Biomed 77 (1), 30Geriatric

(2004): Abriel H+, Swiss Med Wkly, 685 [REVIEW]

Tachycardia 

(2005): Kim MH+, Pacing Clin Electrophysiol 28(11), 1221

Torsades de pointes 

(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW] (fatal)Fatal

(2010): Guo D+, Pharmazie 65(9), 631 [REVIEW]

(2007): Huang BH+, Pacing Clin Electrophysiol 30 (12), 1579

(2002): Shaffer D+, Clin Infect Dis 35(2), 197 [REVIEW]

Anorexia 2–10%

(package insert)

Dysgeusia (taste perversion) 

(2007): Drew H+, J N J Dent Assoc 78(2), 24

Fever (pyrexia) 

(2003): Taylor WR+, Antimicrob Agents Chemother 47(7), 2199

Headache 

(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW]<5%

(2014): Sagara I+, Malar J 13(1), 458 (with chloroquine)

(2011): Cai Y+, J Antimicrob Chemother 66(5), 968 [REVIEW]

Hypothermia 

(2017): Benn K+, Am J Case Rep 18, 883Pediatric

Paresthesias 

(2003): Taylor WR+, Antimicrob Agents Chemother 47(7), 2199

Vertigo (dizziness) 

(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW]<5%

(2014): Sagara I+, Malar J 13(1), 458 (with chloroquine)

Abdominal pain 2–10%

(2013): Wong RH+, Ann Thorac Surg 95(4), 95

(2012): Lakos AK+, Curr Med Res Opin 28(1), 1553%Pediatric

(2011): Cai Y+, J Antimicrob Chemother 66(5), 968 [REVIEW]

(1999): Cazzola M+, J Chemother 11(2), 119

Diarrhea 4–9%

(2020): Kobbernagel HE+, Lancet Respir Med 8(5), 493

(2018): Oldenburg CE+, PLoS Negl Trop Dis 12(11)Pediatric

(2015): Abely M+, Rev Mal Respir (French) 32(6), 557

(2015): Chopra R+, Expert Opin Drug Saf 14(3), 401 [REVIEW]

(2015): Mitja O+, N Engl J Med 372(8), 703 (mild)

(2015): Tandon VR+, Indian J Med Res 142(1), 33

(2014): Begum B+, Mymensingh Med J 23(3), 441Pediatric

(2014): Donde S+, Indian J Otolaryngol Head Neck Surg 66(Suppl 1), 2251%

(2014): Kakeya H+, PLoS One 9(3), e91293 (3 cases) (with oseltamivir)

(2014): Mikamo H+, J Infect Chemother 20(7), 429 (mild or moderate)

(2014): Noguchi S+, Jpn J Antibiot (Japanese) 67(3), 193 (4 cases)

(2014): Otake H+, Acta Otolaryngol 134(2), 181

(2014): Uzun S+, Lancet Respir Med 2(5), 36119%

(2013): Wong RH+, Ann Thorac Surg 95(4), e95

(2012): Lakos AK+, Curr Med Res Opin 28(1), 1556%Pediatric

(2011): Cai Y+, J Antimicrob Chemother 66(5), 968 [REVIEW]

(2009): Florescu DF+, Pulm Pharmacol Ther 22 (6), 467

(2000): Krause PJ+, N Engl J Med 343(20), 14548% (with atovaquone)

(1999): Cazzola M+, J Chemother 11(2), 119

Flatulence 

(2014): Donde S+, Indian J Otolaryngol Head Neck Surg 66(Suppl 1), 2251%

Gastrointestinal disorder 

(2018): Pomares X+, Chest Feb, Epub ahead of print7% (long-term use)

(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW]<5%

(2013): Wong RH+, Ann Thorac Surg 95(4), 95 (40%)

Hepatotoxicity Life threatening

(2017): Koffas A+, Oxf Med Case Reports Jun, Epub

(2016): Sarges P+, Drug Saf 39(9), 801 [REVIEW]

(2015): Moy BT+, Conn Med 79(4), 213

(2015): Stine JG+, Liver Int 35(11), 2343 [REVIEW]

(2014): Noguchi S+, Jpn J Antibiot (Japanese) 67(3), 193 (mild / 15 cases)

(2010): Lockwood AM+, Am J Health Syst Pharm 67(10), 810 (1 case)

(2005): Baciewicz AM+, Am J Med 118(12), 1438

Loose stools 

(2020): Kobbernagel HE+, Lancet Respir Med 8(5), 493

Nausea 7%

(2015): Abely M+, Rev Mal Respir (French) 32(6), 557

(2015): Chopra R+, Expert Opin Drug Saf 14(3), 401 [REVIEW]

(2015): Mitja O+, N Engl J Med 372(8), 703 (mild)

(2014): Begum B+, Mymensingh Med J 23(3), 441Pediatric

(2014): Mikamo H+, J Infect Chemother 20(7), 429 (mild or moderate)

(2011): Cai Y+, J Antimicrob Chemother 66(5), 968 [REVIEW]

(2009): Florescu DF+, Pulm Pharmacol Ther 22 (6), 467

(1999): Cazzola M+, J Chemother 11(2), 119

Vanishing bile duct syndrome 

(2010): Danica J+, Basic Clin Pharmacol Toxicol 106 (1), 62

(2010): Juricic D+, Basic Clin Pharmacol Toxicol 106(1), 62

Vomiting  2–10%

(2018): Oldenburg CE+, PLoS Negl Trop Dis 12(11)Pediatric

(2015): Mitja O+, N Engl J Med 372(8), 703 (mild)

(2014): Begum B+, Mymensingh Med J 23(3), 441Pediatric

(2014): Sagara I+, Malar J 13(1), 458 (with chloroquine)

(2012): Lakos AK+, Curr Med Res Opin 28(1), 1554%Pediatric

(2011): Cai Y+, J Antimicrob Chemother 66(5), 968 [REVIEW]

Vaginitis 2–10%

(1991): Mallory SB, Am J Med 91(3A), 36S

Bleeding 

(2014): Lane MA+, Am J Med 127(7), 657 (with warfarin)

Injection-site erythema 2–10%

(1997): Luke DR+, Ann Pharmacother 31, 965

Injection-site pain 2–10%

(2014): Mikamo H+, J Infect Chemother 20(7), 429 (mild or moderate)

(2001): Zimmerman T+, Clin Drug Invest 21, 527 67%

(1997): Luke DR+, Ann Pharmacother 31, 965

Arthralgia 

(2015): Abely M+, Rev Mal Respir (French) 32(6), 557

Rhabdomyolysis 

(2009): Strandell J+, Br J Clin Pharmacol 68 (3), 427 (with statins)

Keratitis 

(2007): Kumar S, Indian J Ophthalmol 55(1), 84

(2007): Pai VH, Indian J Ophthalmol 55(4), 320

Uveitis 

(2005): Biuk D+, Coll Antropol 29 suppl 1, 127

Hearing loss 

(2018): Pomares X+, Chest Feb, Epub ahead of print5% (long-term use)

(2015): Abely M+, Rev Mal Respir (French) 32(6), 557

(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW]

(2014): Li H+, Antimicrob Agents Chemother 58(1), 511 [REVIEW] (long-term use)

Tinnitus 

(2015): Abely M+, Rev Mal Respir (French) 32(6), 557

(2003): Taylor WR+, Antimicrob Agents Chemother 47(7), 2199

Nephrotoxicity 

(2015): Woodruff AE+, Pharmacotherapy 35(11), e169

Cough 

(2011): Cai Y+, J Antimicrob Chemother 66(5), 968 [REVIEW]

Adverse effects 

(2015): Arnez M+, Pediatr Infect Dis J 34(10), 104521%

(2015): Tandon VR+, Indian J Med Microbiol 33(3), 3937%

(2014): Donde S+, Indian J Otolaryngol Head Neck Surg 66(Suppl 1), 2254%

(2014): Geisler WM+, Antimicrob Agents Chemother 58(7), 401462%

(2014): Kirkcaldy RD+, Clin Infect Dis 59(8), 1083 (gastrointestinal / with gemifloxacin or gentamicin)

(2014): Li H+, PLoS One 9(2), e89829Pediatric

(2014): Noguchi S+, Jpn J Antibiot (Japanese) 67(3), 193 (20 cases)

(2014): Uzun S+, Lancet Respir Med 2(5), 3613% (serious)

(2014): Yasuda M+, J Antimicrob Chemother 69(11), 3116 (mild / 46 cases)

(2013): Hasibur MR+, Mymensingh Med J 22 (1), 42

(2012): Mitja O+, Lancet 379(9813), 3428%Pediatric (mild or moderate)

(2012): Uchit GP+, J Indian Med Assoc 110(4), 2245%

(2011): Southern KW+, Cochrane Database Syst Rev Dec(12), CD002203 (once weekly high dose / gastrointestinal)

(2003): Jennings MB+, Cutis 72(3), 240

Allergic reactions <1%

(package insert)

Death 

(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW]

(2014): Khan MS+, J Pak Med Assoc 64(2), 238

Hiccups 

(2008): Surendiran A+, J Postgrad Med 54(4), 330

(2005): Jover F+, J Clin Pharm Ther 30(4), 413

Side effects 

(1999): Cazzola M+, J Chemother 11(2), 11913% (mild)

(1993): Hopkins S, J Antimicrob Chemother 31 Suppl E, 111



Adverse reactions attributed to entire drug class Antibiotic; macrolide

Cardiac disorder 

(2019): Bonaldo G+, Pharmacoepidemiol Drug Saf Aug, Epub ahead of print [REVIEW]

Neurotoxicity 

(2014): Mattappalil A+, Clin Ther 36(11), 1489 [REVIEW]Geriatric

Hearing loss 

(2018): Ikeda AK+, Laryngoscope 128(1), 228 [REVIEW]

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

Cutaneous adverse reaction  

(2020): Tursen U+, Dermatol Ther May, Epub ahead of print [REVIEW]

Cardiovascular adverse effect 

(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]

Gastrointestinal disorder 

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

Hepatic disorder 

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

Thrombocytopenia 

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

Adverse effects 

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

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

Page last updated 05/10/2020

Drug Eruption Mobile Site

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Incidence info

  • <1%
  • 1-5%
  • 5-10%
  • 10-15%
  • 15-20%
  • 20-30%
  • >30%

Seriousness info

  • Hospitalization possible
  • Life threatening
  • Fatal

Warnings in other populations info

  • Breast feeding
  • Geriatric
  • Pediatric
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