FDA — authorised 8 October 1965
- Application: NDA016080
- Marketing authorisation holder: B BRAUN
- Local brand name: MANNITOL 15%
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Mannitol 15% in United States
FDA authorised Mannitol 15% on 8 October 1965 · 5,066 US adverse-event reports
Marketing authorisations
FDA — authorised 22 December 1967
- Application: NDA016269
- Marketing authorisation holder: HOSPIRA
- Local brand name: MANNITOL 15%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA016472
- Marketing authorisation holder: MILES
- Local brand name: MANNITOL 15%
- Indication: INJECTABLE — INJECTION
- 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: 5,066
Most-reported reactions
- Pain — 648 reports (12.79%)
- Renal Failure — 625 reports (12.34%)
- Anxiety — 517 reports (10.21%)
- Injury — 499 reports (9.85%)
- Renal Impairment — 486 reports (9.59%)
- Unevaluable Event — 476 reports (9.4%)
- Drug Ineffective — 471 reports (9.3%)
- Death — 464 reports (9.16%)
- Stress — 444 reports (8.76%)
- Fear — 436 reports (8.61%)
Mannitol 15% 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 Mannitol 15% approved in United States?
Yes. FDA authorised it on 8 October 1965; FDA authorised it on 22 December 1967; FDA has authorised it.
Who is the marketing authorisation holder for Mannitol 15% in United States?
B BRAUN holds the US marketing authorisation.