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Azithromycin

Azithromycin, Azyter, Zithromax · ATC code J01FA10

Also known as: Azitromisin · Brand names: Azyter, Zithromax, Azi-Teva, Infectoazit, Ultreon, Adamaks, Azax, Azeltin, Azitro, Azomax, Azro, Maxitro, Tiaset, Tremac, Zitorel …

Key facts
Active substance
Azithromycin
Drug class
Macrolide antibiotic
ATC code
J01FA10
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Azithromycin is a macrolide antibacterial. Per the US prescribing information, it treats mild to moderate infections caused by susceptible organisms in adults and children.

What it is used for

  • Adults: acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis
  • Adults: community-acquired pneumonia suitable for oral therapy, pharyngitis/tonsillitis as an alternative
  • Adults: uncomplicated skin and skin structure infections, urethritis and cervicitis, chancroid in men
  • Children: acute otitis media, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis

Dosing

  • Adults, pneumonia, pharyngitis, skin: 500 mg on Day 1, then 250 mg once daily on Days 2 through 5.
  • Adults, acute bacterial sinusitis: 500 mg once daily for 3 days.
  • Adults, chancroid and non-gonococcal urethritis/cervicitis: one single 1 gram dose; gonococcal urethritis/cervicitis: one single 2 gram dose.
  • Children, otitis media: 30 mg/kg once, or 10 mg/kg once daily for 3 days, or 10 mg/kg on Day 1 then 5 mg/kg/day on Days 2 through 5.
  • Children, pharyngitis/tonsillitis: 12 mg/kg once daily for 5 days.
  • Take with or without food; weight-based tables are in the full text.

Contraindications

  • Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide
  • History of cholestatic jaundice/hepatic dysfunction with prior azithromycin use

Important warnings

  • Serious allergic reactions (angioedema, anaphylaxis, SJS, TEN, AGEP, DRESS), including fatalities; symptoms may recur
  • Hepatotoxicity up to hepatic failure; discontinue immediately if hepatitis occurs
  • Infantile hypertrophic pyloric stenosis
  • QT prolongation and cardiovascular death
  • Clostridioides difficile-associated diarrhea; exacerbation of myasthenia gravis

Side effects

  • Gastrointestinal effects such as diarrhea, nausea and abdominal pain
  • Liver enzyme abnormalities and hearing impairment
  • Serious hypersensitivity and skin reactions (rare, some fatal)
  • QT prolongation

Interactions

  • Nelfinavir: raises azithromycin levels; monitor for liver enzyme abnormalities and hearing impairment
  • Warfarin: effect may be potentiated; monitor prothrombin time
  • Other macrolide interactions are in the full text

Pregnancy and breastfeeding

  • Decades of literature and postmarketing data have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Azithromycin1a Pharma Gmbh, Dr. Friedrich Eberth Arzneimittel Gmbh, Teva B.V, Genericon Pharma Gesellschaft M.B.H., +pharma Arzneimittel Gmbh, Inresa Arzneimittel Gmbh, Sandoz Gmbh, Stada Arzneimittel Gmbh, Krka, D.D., Novo Mesto · 10 register entries
  • AzyterLaboratoires Thea · 1 register entry
  • ZithromaxPfizer Corporation Austria Ges.M.B.H. · 3 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Azi-TevaTeva Gmbh · 1 register entry
  • Azithromycin1 A Pharma Gmbh, Dr. Friedrich Eberth Arzneimittel Gmbh, Sia, Zim Laboratories Limited, Bluepharma Indústria Farmacêutica S.A., Ratiopharm Gmbh, Hec Pharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Inresa Arzneimittel Gmbh, Gufic Ireland Limited, Hexal Ag, Stadapharm Gmbh, Denk Pharma Gmbh & Co. Kg, Mylan Germany Gmbh, Abz-Pharma Gmbh, Tad Pharma Gmbh, Aliud Pharma Gmbh · 24 register entries
  • AzyterLaboratoires Thea · 1 register entry
  • InfectoazitInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
  • UltreonPfizer Pharma Gmbh · 1 register entry
  • ZithromaxPfizer Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AdamaksADVANCE İLAÇ A.Ş. · 2 register entries
  • AzaxNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • AzeltinBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • AzitroDEVA HOLDİNG A.Ş. · 5 register entries
  • AzomaxKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 3 register entries
  • AzroSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 3 register entries
  • MaxitroCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • TiasetASET İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • TremacSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • ZitorelPHARMAPLACE İLAÇ TİC. A.Ş. · 1 register entry
  • ZitrasinWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • ZitrocidORBİS PHARMA İLAÇ VE KİMYA KOZMETİK MEDİKAL SAN. TİC. LTD. ŞTİ. · 1 register entry
Show all 14 brand names
  • ZitromaxPFİZER PFE İLAÇLARI A.Ş. · 4 register entries
  • ZitrotekPFİZER PFE İLAÇLARI A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • AzasiteThea Pharma Inc. · 1 register entry
  • ZithromaxPfizer Laboratories Div Pfizer Inc · 2 register entries

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries
Belgium
Azithromycin Ab, Azithromycin Teva, Azithromycine Eg, Azithromycine Sandoz, Azithromycine Teva, Zitromax
Bulgaria
Azax, Aзитер, Азакс, Азатрил, Азибиот, Азитрокс, Азитромицин Абр, Азитромицин Ромфарм, Зетрум, Сумамед
Croatia
Azibiot, Azimed, Azitromicin Belupo, Azitromicin Forte Sandoz, Azitromicin Pharmas, Azitromicin Sandoz, Azyter, Makromicin, Sumamed
Cyprus
Azithran, Azithromycin Altan Pharmaceuticals S.A., Azithromycin Jubilant, Azyter, Bezanin, Razimax, Zinfect, Zithromax, Zithrotel
Czechia
Azitromycin Sandoz, Azitromycin Viatris, Azitrox, Azyter, Sumamed
Denmark
Amzolynic, Azithromycin "sandoz", Azithromycin Jubilant, Azithromycin Krka, Azithromycin Sandoz, Azithromycin Stada, Azithromycin Teva, Azithromycin Viatris, Azyter, Zitromax
Estonia
Azithromycin Krka, Azithromycin Sandoz, Azitrox, Sumamed
Finland
Amzolynic, Atsitromysiini Gufic, Azithromycin Krka, Azithromycin Orion, Azithromycin Ratiopharm, Azithromycin Sandoz, Azithromycin Stada, Azyter, Zithromax
France
Azadose, Azithromycine Arrow Lab, Azithromycine Bgr, Azithromycine Bluepharma, Azithromycine Cristers Pharma, Azithromycine Eg, Azithromycine Evolugen, Azithromycine Krka, Azithromycine Monodose Sandoz, Azithromycine Pfizer, Azithromycine Sandoz, Azithromycine Teva, Azithromycine Viatris, Azithromycine Zentiva, Azithromycine Zydus, Azyter, Ordipha, Zithromax
Greece
Alzirax, Azibactron, Azifarm, Azirox, Azirutec, Azithromycin Kleva, Azithromycin Syndesmos, Azithromycin Vocate, Azivirus, Azyter, Bezanin, Ciroz, Disithrom, Goldamycin, Novozithron, Razimax, Zinfect, Zithro-Due, Zithrobest, Zithromax, Zithroplus, Zithrotel, Zithroxyn
Hungary
Azi, Azibactim, Azibiot, Azithromycin, Sumamed, Zitrocin
Iceland
Azithromycin Stada, Azitromicina Normon, Azyter, Zitromax
Ireland
Azithromycin Clonmel, Azithromycin Krka, Azithromycin Teva, Azromax, Azyter, Zedbac, Zithromax
Italy
Azacid, Azeptin, Aziprome, Azitredil, Azitroerre, Azitromicina Abc, Azitromicina Accord, Azitromicina Almus, Azitromicina Altan Pharmaceuticals S.A., Azitromicina Aurobindo, Azitromicina Bluepharma, Azitromicina Doc Generici, Azitromicina Eg, Azitromicina Krka, Azitromicina Mylan, Azitromicina Pensa, Azitromicina Pharmeg, Azitromicina Sandoz, Azitromicina Teva, Azitromicina Zentiva, Azitrox, Azylung, Azyter, Batif, Macrozit, Portex, Rezan, Tetris, Trozamil, Trozocina, Zimacrol, Zindel, Zitrobiotic, Zitrogram, Zitromax, Zitronova
Latvia
Azibiot, Azithromycin Sandoz, Sumamed
Lithuania
Azibiot, Azithromycin Ingen Pharma, Azithromycin Sandoz, Azithromycin Teva, Azitrox, Sumamed
Luxembourg
Azithromycin Ratiopharm, Azithromycine Eg, Azyter, Zitromax
Malta
Azimycin, Azithromycin Aurobindo, Azithromycin Clonmel, Azitredil, Zinfect, Zithromax
Netherlands
Azithromycin Dihydrate Aurobindo, Azithromycine Ratiopharm, Azithromycine Teva, Azitromycine Eberth, Azitromycine Jubilant, Azitromycine Ratiopharm, Azitromycine Sandoz, Azitromycine Teva, Azitromycine Viatris, Azyter, Bazyt, Zithromax
Norway
Amzolynic, Azitromax, Azyter
Poland
Azibiot, Azimycin, Azithromycin Aurovitas, Azithromycin Genoptim, Azithromycin Krka, Azithromycin Teva, Azithromycin Zim, Azitrolek, Azitrox, Azycyna, Azyter, Macromax, Nobaxin, Sumamed
Portugal
Azitrix, Azitromicina Almus, Azitromicina Altan, Azitromicina Alter, Azitromicina Alvyx, Azitromicina Atral, Azitromicina Aurobindo, Azitromicina Aurovitas, Azitromicina Azevedos, Azitromicina Azitrix, Azitromicina Basi, Azitromicina Biofarmoz, Azitromicina Bluepharma, Azitromicina Ciclum, Azitromicina Farmoz, Azitromicina Generis, Azitromicina Germed, Azitromicina Gp, Azitromicina Gufic, Azitromicina Jaba, Azitromicina Kabi, Azitromicina Krka, Azitromicina Labesfal, Azitromicina Legin, Azitromicina Medlink, Azitromicina Mylan, Azitromicina Oara Bluepharma – Indústria Farmacêutica, Azitromicina Pentafarma, Azitromicina Pharmakern, Azitromicina Sandoz, Azitromicina Tecnigen, Azitromicina Teva, Azitromicina Tolife, Azitromicina Vitória, Azitromicina Zentiva, Azitromicina Zim, Azyter, Bloza, Bluesar, Sumamed, Ziger, Zithromax, Zitrozina
Romania
Azibiot, Azitromicina Sandoz, Azitromicină Arena, Azitromicină Rompharm, Azitromicină Sandoz, Azitromicină Terapia, Azitrox, Azyter, Sumamed
Slovakia
Azibiot, Azithromycin Sandoz, Azitromycin Viatris, Azitrox, Sumamed
Slovenia
Azibiot, Azitromicin Krka, Azyter, Sumamed
Spain
Aratro, Azitromicina Almus, Azitromicina Altan, Azitromicina Alter, Azitromicina Aurovitas, Azitromicina Auxil, Azitromicina Bluepharma, Azitromicina Cinfa, Azitromicina Combix, Azitromicina Jubilant, Azitromicina Kern Pharma, Azitromicina Korhispana, Azitromicina Krka, Azitromicina Mabo, Azitromicina Normon, Azitromicina Pensa, Azitromicina Qualigen, Azitromicina Sandoz, Azitromicina Stada, Azitromicina Tarbis, Azitromicina Tecnigen, Azitromicina Teva, Azitromicina Tevagen, Azitromicina Vegal, Azitromicina Viatris, Azitromicina Vir, Azitromicina Zim, Azydrop, Zitromax
Sweden
Amzolynic, Azithromycin Jubilant, Azithromycin Krka, Azithromycin Sandoz, Azithromycin Stada, Azithromycin Viatris, Azitromax, Azyter

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. U.S. Food and Drug Administration. azithromycin (Rising Pharma Holdings, Inc.) – Prescribing Information, 2026-02-26. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5199689f-8881-7757-e063-6394a90ae2eb
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC J01FA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.