FDA — authorised 16 February 1978
- Application: NDA016741
- Marketing authorisation holder: B BRAUN
- Local brand name: SORBITOL 3.3% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
🇺🇸 SORBITOL in United States
FDA authorised SORBITOL on 16 February 1978 · 658 US adverse-event reports
Marketing authorisations
FDA — authorised 30 May 1980
- Application: NDA017863
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SORBITOL 3% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 28 February 1984
- Application: NDA018512
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SORBITOL 3% IN PLASTIC CONTAINER
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 11 January 1990
- Application: NDA018316
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 658
Most-reported reactions
- Vomiting — 83 reports (12.61%)
- Constipation — 75 reports (11.4%)
- Diarrhoea — 74 reports (11.25%)
- Fall — 71 reports (10.79%)
- Pain — 68 reports (10.33%)
- Nausea — 63 reports (9.57%)
- Fatigue — 59 reports (8.97%)
- Drug Ineffective — 58 reports (8.81%)
- Acute Kidney Injury — 54 reports (8.21%)
- Dizziness — 53 reports (8.05%)
SORBITOL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SORBITOL approved in United States?
Yes. FDA authorised it on 16 February 1978; FDA authorised it on 30 May 1980; FDA authorised it on 28 February 1984.
Who is the marketing authorisation holder for SORBITOL in United States?
B BRAUN holds the US marketing authorisation.