Azithromycin
- 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: Antibiotic, Antibiotic; macrolide, Antimicrobial, Covid-19 putative drug
- HALF-LIFE: 68 hours
Aminophylline, Antacids, Artemether/Lumefantrine, Astemizole, Atorvastatin, Betrixaban, Bromocriptine, Cabergoline, Colchicine, Coumarins, Cyclosporine, Digoxin, Droperidol, Ergotamine, Fluvastatin, Lovastatin, Methysergide, Mizolastine, Oral typhoid vaccine, Pimozide, Pravastatin, Quetiapine, Reboxetine, Rifabutin, Ritonavir, Simvastatin, Venetoclax, Warfarin
PREGNANCY CATEGORY: B
See adverse reactions attributed to class:
AzaSite is for topical ophthalmic use only (see reactions noted [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 / Eosinophilic Granulomatosis with Polyangiitis (EGPA) / Churg-Strauss syndrome (see also anti-neutrophil cytoplasmic antibody (ANCA) vasculitis (angiitis)
(1998): Dietz A+, Laryngorhinootologie 77(2), 111 (with roxithromycin)
(1997): Kranke B+, Lancet 350, 1551
Anaphylactoid reactions / anaphylaxis (includes anaphylactic shock)
(2014): Mori F+, Int J Immunopathol Pharmacol 27(1), 121
(2008): Todisco T+, J Chemother 20(2), 225 (with ampicillin/sulbactam)
Cutaneous toxicity / skin toxicity
(2000): Granowitz EV+, Pacing Clin Electrophysiol 23(9), 1433 (with disopyramide)
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), 75
(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), 128
(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
Linear IgA bullous dermatosis
(2007): Cummings JE+, Cutis 79 (3), 203 (with rimantadine and zanamivir)
Pruritus (itching)
(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)
Rash 2–10%
[Ophth]
(2018): Oldenburg CE+, PLoS Negl Trop Dis 12(11)
(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]
(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
Urticaria / hives
[Ophth]
(2001): Thaler D, Monana, WI (from Internet / observation)
(1991): Mallory SB, Am J Med 91(3A), 36S
Aphthous stomatitis / aphthous ulcer / aphtha (aphthae)
(2019): Moghadam ET+, Curr Clin Pharmacol March, Epub ahead of print (3 cases)
Bradycardia / sinus bradycardia
(2017): Benn K+, Am J Case Rep 18, 883
(2010): Santos N+, Rev Port Cardiol 29(1), 139
Cardiotoxicity
(2014): Khan MS+, J Pak Med Assoc 64(2), 238 (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 interval prolonged / QT prolongation
(2020): Al-Jazairi AS+, Am J Case Rep 21, e926951 (1 case / female)
(2015): Chopra R+, Expert Opin Drug Saf 14(3), 401 [REVIEW]
(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW] (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), 30
(2004): Abriel H+, Swiss Med Wkly, 685 [REVIEW]
Torsades de pointes
(2021): Saint-Gerons DM+, Eur J Clin Pharmacol May, Online ahead of print (100 cases)
(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW] (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]
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]
Vertigo / dizziness
(2015): McMullan BJ+, Aust Prescr 38(3), 87 [REVIEW]<5%
(2014): Sagara I+, Malar J 13(1), 458 (with chloroquine)
Inappropriate secretion of antidiuretic hormone (SIADH)
(1997): Cadle RM+, Ann Pharmacother 31(11), 1308
Abdominal pain 2–10%
(2013): Wong RH+, Ann Thorac Surg 95(4), 95
(2012): Lakos AK+, Curr Med Res Opin 28(1), 1553%
(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)
(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), 441
(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%
(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
Gastrointestinal disorder / discomfort
(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 / liver injury / acute liver injury / drug-induced liver injury (DILI) 
(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
Nausea 7%
(2020): Livezey J+, Malar J 19(1), 33613% (severe) (with chloroquine)
(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), 441
(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)
(2015): Mitja O+, N Engl J Med 372(8), 703 (mild)
(2014): Begum B+, Mymensingh Med J 23(3), 441
(2014): Sagara I+, Malar J 13(1), 458 (with chloroquine)
(2012): Lakos AK+, Curr Med Res Opin 28(1), 1554%
(2011): Cai Y+, J Antimicrob Chemother 66(5), 968 [REVIEW]
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
Keratitis
(2007): Kumar S, Indian J Ophthalmol 55(1), 84
(2007): Pai VH, Indian J Ophthalmol 55(4), 320
Uveitis / anterior uveitis / posterior uveitis / panuveitis
(2005): Biuk D+, Coll Antropol 29 suppl 1, 127
Hearing loss (hypoacusis)
(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 / kidney injury / acute kidney injury (AKI) / drug-induced kidney injury
(2015): Woodruff AE+, Pharmacotherapy 35(11), e169
Adverse effects / adverse reactions
(2021): Li D+, Transl Pediatr 10(10), 2594-2601 [REVIEW]
(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), e89829
(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% (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
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
Acute generalized exanthematous pustulosis (AGEP)
(2014): Lin YF+, Clin Infect Dis 58(10), 1377
Anaphylactoid reactions / anaphylaxis (includes anaphylactic shock)
(2020): Yu RJ+, J Allergy Clin Immunol Pract Sep, Online ahead of print [REVIEW]
Cutaneous adverse reaction (includes severe cutaneous adverse drug reaction (SCAR))
(2022): Martins JC+, An Bras Dermatol Apr, Online ahead of print
(2021): Villanueva-Paz M+, J Clin Med 10(22), 5317 [REVIEW]
DRESS syndrome
(2014): Lin YF+, Clin Infect Dis 58(10), 1377
Hypersensitivity
(2010): Um SJ+, J Investig Allergol Clin Immunol 20(7), 556
Stevens-Johnson syndrome
(2014): Lin YF+, Clin Infect Dis 58(10), 1377
(2014): Su P+, Int J Dermatol 53(11), 1339
(2011): Singalavanija S+, J Med Assoc Thai 94 Suppl 3, S85
Toxic epidermal necrolysis (Lyell's syndrome)
(2014): Lin YF+, Clin Infect Dis 58(10), 1377
Oral changes
(2020): Aziz Y+, Oral Dis Oct, Online ahead of print [REVIEW]
Ageusia (taste loss) / taste disorder
(2021): Kan Y+, Sci Rep 11(1), 9625 [REVIEW]
Anosmia (smell loss) / smell disorder
(2021): Kan Y+, Sci Rep 11(1), 9625 [REVIEW]
Mania
(2017): Lambrichts S+, J Affect Disord 219, 149-156 [REVIEW] (47 cases)
(2002): Abouesh A+, J Clin Psychopharmacol 22(1), 71-81 [REVIEW]
Hepatotoxicity / liver injury / acute liver injury / drug-induced liver injury (DILI)
(2021): Kong X+, Br J Clin Pharmacol May, Online ahead of print [REVIEW]
(2021): Villanueva-Paz M+, J Clin Med 10(22), 5317 [REVIEW]
Hematological inflammatory markers raised
(2019): Eom KS, J Korean Neurosurg Soc May, Epub ahead of print (2 cases)
Neutropenia (neutrophils decreased)
(2022): Battini V+, Front Pharmacol Jun, eCollection
Thrombocytopenia
(2021): Asai Y+, Int J Toxicol Oct, Online ahead of print
Ototoxicity
(2020): Rizk HG+, Pharmacotherapy Oct, Online ahead of print [REVIEW]
Nephrotoxicity / kidney injury / acute kidney injury (AKI) / drug-induced kidney injury
(2022): Rey A+, Fundam Clin Pharmacol Jan, Online ahead of print
Adverse effects / adverse reactions
(2022): Browning S+, Clin Microbiol Infect Jan, Online ahead of print3% ('major') (intravenous administration)
(2022): Leporini C+, Drug Saf Sep, Online ahead of print [REVIEW]
Adverse reactions attributed to entire drug class Antibiotic; macrolide
Cardiac disorder / cardiac dysfunction
(2019): Bonaldo G+, Pharmacoepidemiol Drug Saf Aug, Epub ahead of print [REVIEW]
Neurotoxicity
(2014): Mattappalil A+, Clin Ther 36(11), 1489 [REVIEW]
Hearing loss (hypoacusis)
(2018): Ikeda AK+, Laryngoscope 128(1), 228 [REVIEW]
Adverse reactions attributed to entire drug class Antimicrobial
Cutaneous adverse reaction (includes severe cutaneous adverse drug reaction (SCAR))
(2021): James J+, Curr Drug Saf Oct, Online ahead of print
Hepatotoxicity / liver injury / acute liver injury / drug-induced liver injury (DILI)
(2021): Huang YS+, J Chin Med Assoc Oct, Online ahead of print47%
Adverse reactions attributed to entire drug class Covid-19 putative drug
Cutaneous adverse reaction (includes severe cutaneous adverse drug reaction (SCAR))
(2020): Tursen U+, Dermatol Ther May, Epub ahead of print [REVIEW]
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 / hepatobiliary 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 / adverse reactions
(2022): Aguilera C+, Diagnostics (Basel) 12(7), 1612
(2022): Chiu MN+, Eur J Clin Pharmacol Jan, Online ahead of print [REVIEW]
(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): Drożdżal S+, Drug Resist Updat Dec, eCollection [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]
Page last updated 08/01/2022
Symbol key
Incidence 
- <1%
- 1-5%
- 5-10%
- 10-15%
- 15-20%
- 20-30%
- >30%
Seriousness
- Hospitalization possible
- Life threatening
- Fatal
Warnings in other populations
- Breast feeding
- Geriatric
- Pediatric
