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Octreotide

Octreotide Ratiopharm, Sandostatin, Siroctid · ATC code H01CB02

Also known as: Octreotid, Oktreotid, Mycapssa · Brand names: Octreotide Ratiopharm, Sandostatin, Siroctid, Octreo Ratiopharm, Octreotid Bendalis, Octreotid Hameln, Octreotid Hexal, Octreotid Sun, Octreotide Hameln, Okrodin, BYNFEZIA Pen

Key facts
Active substance
Octreotide
Drug class
Hypothalamic hormones
ATC code
H01CB02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Octreotide is a somatostatin analog. Per the US prescribing information, its oral capsules (MYCAPSSA) are used for long-term maintenance treatment of acromegaly.

What it is used for

  • Long-term maintenance treatment in acromegaly patients who have responded to and tolerated octreotide or lanreotide

Dosing

  • Take with a glass of water on an empty stomach, at least 1 hour before or 2 hours after a meal; swallow capsules whole
  • Start at 40 mg daily (20 mg twice daily); increase in 20 mg daily increments based on IGF-1 and symptoms
  • 60 mg daily as 40 mg in the morning and 20 mg in the evening; 80 mg daily as 40 mg twice daily; maximum 80 mg daily
  • Monitor IGF-1 every two weeks during titration, then monthly
  • End-stage renal disease: start 20 mg once daily; with PPIs, H2 blockers or antacids higher doses may be needed

Contraindications

  • Hypersensitivity to octreotide or any component of MYCAPSSA

Important warnings

  • Cholelithiasis and its complications (cholecystitis, cholangitis, pancreatitis); monitor periodically
  • Hyper- and hypoglycemia: increased blood glucose 7%, hypoglycemia 4%; monitor glucose at initiation and dose changes
  • Hypothyroidism due to TSH suppression
  • Cardiac conduction abnormalities and ECG changes, e.g. bradycardia (2%)
  • Steatorrhea and malabsorption of dietary fats; changes in vitamin B12 levels

Side effects

  • Placebo-controlled study: diarrhea 29%, nausea 21%, blood glucose increased 14%, vomiting 14%, abdominal discomfort 14%, dyspepsia 11%
  • Open-label study: headache 33%, nausea 30%, arthralgia 26%, asthenia 22%, hyperhidrosis 21%, diarrhea 18%
  • Cholelithiasis 7%

Interactions

  • Proton pump inhibitors, H2 blockers, antacids: reduced octreotide bioavailability
  • Cyclosporine: reduced bioavailability, dose adjustment may be needed; digoxin: decreased peak exposure
  • Insulin and antidiabetics: dose adjustment may be needed; lisinopril and bromocriptine: increased exposure
  • Beta blockers or calcium channel blockers: dose adjustment may be needed

Pregnancy and breastfeeding

  • Case reports are insufficient to identify a drug-associated risk
  • No information on presence in human milk

Summary of the official product information, written with AI on 2026-10-29. 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)

This product has no separate US patient information.

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

  • Octreotide RatiopharmTeva B.V · 1 register entry
  • SandostatinNovartis Pharma Gmbh · 2 register entries
  • SiroctidChemi S.P.A. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Octreo RatiopharmRatiopharm Gmbh · 2 register entries
  • Octreotid BendalisBendalis Gmbh · 1 register entry
  • Octreotid HamelnChemi S.P.A. · 1 register entry
  • Octreotid HexalHexal Ag · 1 register entry
  • Octreotid SunSun Pharmaceuticals Germany Gmbh · 1 register entry
  • Octreotide HamelnChemi S.P.A. · 1 register entry
  • OkrodinPharmathen S.A. · 1 register entry
  • SandostatinNovartis Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • SandostatinNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 4 register entries

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

USA

  • BYNFEZIA PenSun Pharmaceutical Industries, Inc. · 1 register entry
  • MycapssaChiesi USA, Inc., Amryt Pharmaceuticals Designated Activity Company · 2 register entries
  • SandostatinNovartis Pharmaceuticals Corporation · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 28 more European countries
Belgium
Octreoteva Long Acting, Octreotide Qilu, Sandostatine, Siroctid
Bulgaria
Octreotid Lyomark, Октреотид Lai Тева, Сандостатин
Croatia
Oktreotid Teva, Sandostatin
Cyprus
Octreotide Rompharm, Sandostatin
Czechia
Octreotide Teva, Okrodin, Sandostatin
Denmark
Octreoanne, Octreotid Sun, Octreotide Orion, Sandostatin
Estonia
Octreotide Teva, Sandostatin
Finland
Octreotide Orion, Octreotide Ratiopharm, Sandostatin
France
Octreotide Arrow, Octreotide Hospira, Octreotide Lp Qilu, Octreotide Lp Teva, Sandostatine, Siroctid
Greece
Okrodin, Sandostatin
Hungary
Oktreotid Teva, Sandostatin
Iceland
Octreoanne, Oczyesa, Sandostatin
Ireland
Octreotide Pfizer Healthcare Ireland, Olatuton, Sandostatin
Italy
Octreotide Bioindustria L.I.M., Octreotide Sun, Octreotide Teva, Sandostatina Lar, Treoject
Latvia
Sandostatin
Liechtenstein
Oczyesa
Lithuania
Octreotide Teva, Sandostatin
Luxembourg
Octreoteva Long Acting, Sandostatine
Malta
Sandostatin
Netherlands
Octreotide Bendalis, Octreotide Depot Teva, Octreotide Labiana, Octreotide Lyomark, Octreotide Sandoz, Sandostatine Lar, Siroctid
Norway
Octreoanne, Octreotide Orion, Oczyesa, Sandostatin
Poland
Okteva, Sandostatin
Portugal
Octreotido Color, Octreotido Depot Teva, Octreótido Sandoz, Sandostatina Lar
Romania
Octreotidă Rompharm, Octreotidă Teva, Sandostatin, Октреотид Ромфарм
Slovakia
Sandostatin
Slovenia
Oktreotid Teva, Sandostatin
Spain
Octreotida Gp-Pharm, Octreotida Sun, Octreotida Teva, Sandostatin
Sweden
Octreotide Orion, Octreotide Teva, Oktreotid Campus, Oktreotid Sun, Sandostatin

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Mycapssa (Chiesi USA, Inc.) – Prescribing Information, 2025-07-24. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=58d80bc6-bdfb-4908-93e7-aace447c8d1a
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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), 2026-10-29. 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), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC H01CB.

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.