zoledronic acid

Aclasta, Zometa · ATC code M05BA08

Also known as: Zoledronsäure · Brand names: Aclasta, Zometa, Zoledronic Acid Koanaa, Zoledronsäure Fresenius Kabi, Zoledronsäure G.L., Zoledronsäure Hikma, Zoledronsäure Noridem, Zoledronsäure Sandoz, Zoledronsäure Stada, Aszora, Clastizol, Zole, Zoledro, Zoledron Uropharm, Zoledronsaure Rafarm …

Key facts
Active substance: zoledronic acid
ATC code: M05BA08
Authorisation: centrally authorised across the EU (EMA)
Dosage forms: Aclasta 5 mg solution for infusion · Zometa 4 mg powder and solvent for solution for infusion · Zometa 4 mg/5 ml concentrate for solution for infusion · Zometa 4 mg/100 ml solution for infusion
Marketing authorisation holder: Sandoz Pharmaceuticals d.d., Phoenix Labs Unlimited Company
Information as of: 2026-10-27

Key facts

Zoledronic acid is a bisphosphonate. As Aclasta it is used for osteoporosis and Paget's disease; as Zometa to prevent skeletal-related events in cancer involving bone and to treat tumour-induced hypercalcaemia.

What it is used for

Aclasta: osteoporosis in post-menopausal women and in men at increased fracture risk, including after recent hip fracture
Aclasta: osteoporosis associated with long-term systemic glucocorticoids; Paget's disease of bone in adults
Zometa: prevention of skeletal-related events in advanced malignancies involving bone
Zometa: tumour-induced hypercalcaemia in adults

Dosing

Aclasta, osteoporosis: 5 mg intravenous infusion once a year; re-evaluate the need periodically, especially after 5 or more years
Aclasta, Paget's disease: single 5 mg infusion; then at least 500 mg elemental calcium twice daily for at least 10 days
Zometa, bone metastases: 4 mg every 3 to 4 weeks, plus daily calcium 500 mg and vitamin D 400 IU; reduced doses at creatinine clearance 30–60 ml/min
Zometa, hypercalcaemia: single dose of 4 mg
Ensure adequate hydration; calculate creatinine clearance before each dose

Contraindications

Hypersensitivity to zoledronic acid, other bisphosphonates or excipients
Aclasta: hypocalcaemia, creatinine clearance < 35 ml/min, pregnancy
Breast-feeding

Important warnings

Renal impairment, rarely renal failure requiring dialysis or fatal; higher risk with pre-existing dysfunction, advanced age, diuretics, dehydration
Osteonecrosis of the jaw
Atypical fractures of the femur
Hypocalcaemia; do not use Zometa and Aclasta together

Side effects

Acute phase reaction after the first infusion: pyrexia (17.1%), myalgia, influenza-like illness, arthralgia, headache
Common: hypocalcaemia, dizziness
Rare: hypophosphataemia; hypersensitivity reactions

Interactions

Nephrotoxic medicines (e.g. aminoglycosides) and diuretics causing dehydration: caution
Aminoglycosides, calcitonin, loop diuretics: possible additive lowering of serum calcium

Pregnancy and breastfeeding

Aclasta: contraindicated in pregnancy and breast-feeding, not recommended in women of childbearing potential; Zometa: contraindicated in breast-feeding

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 →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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.

EU – centrally authorised (all member states)

AclastaSandoz Pharmaceuticals d.d. · EMEA/H/C/000595
Zoledronic Acid Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/002667
Zoledronic acid Mylan · genericMylan Pharmaceuticals Limited · EMEA/H/C/002482
Zoledronic acid Teva · genericTeva B.V. · EMEA/H/C/002439
ZometaPhoenix Labs Unlimited Company · EMEA/H/C/000336

Source: European Medicines Agency (EMA), product information

Austria

Zoledronic Acid KoanaaKoanaa Healthcare Spain S.L. · 1 register entry
Zoledronsäure Fresenius KabiFresenius Kabi Austria Gmbh · 1 register entry
Zoledronsäure G.L.G.L. Pharma Gmbh · 1 register entry
Zoledronsäure HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
Zoledronsäure NoridemNoridem Enterprises Ltd · 1 register entry
Zoledronsäure SandozSandoz Gmbh · 1 register entry
Zoledronsäure StadaStada Arzneimittel Gmbh · 1 register entry

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

Germany

AszoraAnwerina Deutschland Gmbh · 2 register entries
ClastizolPharma Bavaria Internacional (Pbi) Portugal Unipessoal Lda · 1 register entry
Zole1 A Pharma Gmbh · 1 register entry
ZoledroDenk Pharma Gmbh & Co. Kg · 1 register entry
Zoledron UropharmAbanta Pharma Gmbh · 1 register entry
Zoledronsaure RafarmRafarm Sa. · 1 register entry
Zoledronsäure1 A Pharma Gmbh, Seacross Pharma (Europe) Ltd, Fresenius Kabi Deutschland Gmbh, Altan Pharmaceuticals S.A., Kelix Bio (Malta) Limited, Tillomed Pharma Gmbh, Logenex Pharm Gmbh, Noridem Enterprises Ltd, Synthon Bv, Genmed Pharma Gmbh, Pharma Resources Gmbh, Denk Pharma Gmbh & Co. Kg, Hexal Ag, Hikma Farmacêutica (Portugal), S.A., Viatris Germany Gmbh, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Sun Pharmaceuticals Germany Gmbh, Aliud Pharma Gmbh · 21 register entries

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

Turkey

Aclabon Infizyon Çözeltisi IçerenKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
AclastaSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
AtazolATABAY KİMYA SAN. VE TİC. A.Ş. · 1 register entry
BondrexHTA İLAÇ ARAŞTIRMA GELİŞTİRME SAN.VE TİC. LTD. ŞTİ. · 1 register entry
BonedroVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
BonzolenFARMAKO ECZACILIK A.Ş. · 1 register entry
CemixHAVER TRAKYA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
KaliksirSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
LaniczolPLATİN KİMYA MÜMESSİLLİK VE DIŞ TİC. A.Ş. · 1 register entry
LusimaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
MetarzuHAVER FARMA İLAÇ A.Ş. · 1 register entry
Multiflex AclaverHAVER FARMA İLAÇ A.Ş. · 1 register entry

Show all 34 brand names

OssiPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
OstezolenRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
PlazolPLATİN KİMYA MÜMESSİLLİK VE DIŞ TİC. A.Ş. · 1 register entry
RonidroVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
RonixCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
VertebzolEXELTIS İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
XendroCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZodinasilGENVEON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZolcureWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZoldriaPHARMADA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZoledrinDEVA HOLDİNG A.Ş. · 1 register entry
ZolegenGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
Zolenat IVGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 1 register entry
ZolestoATABAY KİMYA SAN. VE TİC. A.Ş. · 1 register entry
ZolkaKAYA BEŞERİ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZolonikKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
ZoloporozPHARMADA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZoltastaWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZoltonarWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
ZomebonKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
ZomtuONKO İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
ZoronicNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 1 register entry

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

Brand names in 27 more European countries

Belgium: Acide Zolédronique Fresenius Kabi, Zoledronate Eg, Zoledronic Acid A.Forall, Zoledronic Acid Sandoz, Zoledroninezuur Altan, Zoledroninezuur Fresenius Kabi, Zoledronsäure Fresenius Kabi
Bulgaria: Золедронова Киселина Ейсфарма, Золедронова Киселина Ромфарм, Золтонар, Зомту
Croatia: Zolenat
Cyprus: Nordeloz, Zoledronic Acid Altan, Zoledronic Acid Rompharm
Czechia: Zoledronic Acid Fresenius Kabi, Zomikos
Denmark: Zoledo, Zoledronsyre Fresenius Kabi, Zoledronsyre Oresund Pharma, Zoledronsyre Stada, Zoledronsyre Sun Pharma, Zolestad
Estonia: Zoledronic Acid Fresenius Kabi
Finland: Zobiore, Zoledronic Acid Fresenius Kabi, Zoledronic Acid Oresund Pharma, Zoledronic Acid Stada, Zoledronic Acid Sun, Zolestad
France: Acide Zoledronique Altan, Acide Zoledronique Biogaran, Acide Zoledronique Sandoz, Acide Zoledronique Seacross, Acide Zoledronique Tillomed, Acide Zoledronique Viatris, Acide Zoledronique Zentiva Lab, Acide Zolédronique Fresenius Kabi, Zoledronic Acid Eg Labo - Laboratoires Eurogenerics
Greece: Bonevin, Nordeloz, Zolmestat
Hungary: Osporil, Zoledronsav Fresenius Kabi, Zoledronsav Healthport, Zoledronsav Meliopharma, Zoledronsav Pharmacenter, Zoledronsav Richter, Zoledronsav Stada, Zoledronsav Vipharm, Zortila
Iceland: Aclasta, Aszora, Osporil, Zoledronic Acid Accord, Zoledronic Acid Mylan, Zoledronic Acid Stada, Zoledronic Acid Teva, Zolestad Stada, Zometa
Ireland: Zerlinda, Zoledronic Acid
Italy: Acido Zoledronico Altan, Acido Zoledronico Fresenius Kabi, Acido Zoledronico Galenica Senese, Acido Zoledronico Hikma, Acido Zoledronico Seacross, Acido Zoledronico Tillomed
Latvia: Zoledronic Acid Fresenius Kabi
Liechtenstein: Aclasta, Zoledronic Acid Accord, Zoledronic Acid Mylan, Zoledronic Acid Teva, Zometa
Lithuania: Zoledronic Acid Fresenius Kabi
Luxembourg: Acide Zolédronique Fresenius Kabi, Zoledronate Eg
Netherlands: Zoledroninezuur Accord, Zoledroninezuur Cf, Zoledroninezuur Fresenius Kabi, Zoledroninezuur Genthon, Zoledroninezuur Hikma, Zoledroninezuur Sandoz, Zoledroninezuur Seacross, Zoledroninezuur Synthon
Norway: Aclasta, Zoledo, Zoledronic Acid Accord, Zoledronic Acid Mylan, Zoledronic Acid Oresund Pharma, Zoledronic Acid Teva, Zoledronsyre Fresenius Kabi, Zoledronsyre Richter, Zoledronsyre Stada, Zoledronsyre Sun Pharma, Zolestad, Zometa
Poland: Osporil, Zerlinda, Zoledronic Acid Accord, Zoledronic Acid Fresenius Kabi, Zoledronic Acid Noridem, Zomikos
Portugal: Clastizol, Dronac, Zolartac, Zolimetax, Ácido Zoledrónico Accord, Ácido Zoledrónico Altan, Ácido Zoledrónico Basi, Ácido Zoledrónico Bluepharma, Ácido Zoledrónico Farmoz, Ácido Zoledrónico Fresenius Kabi, Ácido Zoledrónico Generis, Ácido Zoledrónico Hikma, Ácido Zoledrónico Normon, Ácido Zoledrónico Seacross, Ácido Zoledrónico Zentiva
Romania: Acid Zoledronic Accord, Acid Zoledronic Fresenius Kabi, Acid Zoledronic Rompharm, Zerlinda
Slovakia: Kyselina, Osporil, Zoledronic Acid Fresenius Kabi, Zoledronic Acid Pharmagen, Zoledronic Acid Viatris, Zomikos
Slovenia: Zoledronska Kislina Accord, Zoledronska Kislina Fresenius Kabi, Zoledronska Kislina Viatris
Spain: Acido Zoledrónico Seacross, Ácido Zoledronico Kabi, Ácido Zoledrónico Accord, Ácido Zoledrónico Altan, Ácido Zoledrónico Normon, Ácido Zoledrónico Tillomed
Sweden: Zerlinda, Zoledronic Acid Accord, Zoledronic Acid Fresenius Kabi, Zoledronic Acid Oresund Pharma, Zoledronic Acid Sun Pharma, Zoledronsyra Stada, Zolestad

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

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Sources

European Medicines Agency. Aclasta – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/aclasta-epar-product-information_en.pdf
European Medicines Agency. Zometa – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/zometa-epar-product-information_en.pdf
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
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
TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.