Strong human trialsIn clinical trials

Survodutide side effects

Also known as: BI 456906 · Surv

Updated Oct 24, 202642 sources

11 side effects reported for Survodutide: 10 from studies and labels, 1 from users and guides. 4 come with the ways people manage them.

Survodutide overview

Side effects reported in studies and labels

Rates as each trial or label states them. A rate from one trial does not carry over to research-grade vials or other doses.

From trials and regulators10

Clinical studies and regulatory documents.

Any stomach or gut side effect
SYNCHRONIZE-1: 80.9% at 3.6 mg and 89.7% at 6.0 mg vs 47.9% on placebo. SYNCHRONIZE-2: 72.8% and 77.7% vs 38.6%. Mostly mild to moderate
How people manage it
- Phase 3 slowed the dose climb and allowed short pauses and one-step dose cuts, so more people reach and keep their dose.
Nausea
SYNCHRONIZE-MASLD at 6.0 mg: 56.2% vs 14.3% on placebo. MASH phase 2: 66% vs 23%
How people manage it
- Most cases came during the dose climb and were mild to moderate.
Vomiting
SYNCHRONIZE-MASLD at 6.0 mg: 42.5% vs 7.1% on placebo. MASH phase 2: 41% vs 4%
Diarrhea
SYNCHRONIZE-MASLD at 6.0 mg: 29.5% vs 10.0% on placebo. MASH phase 2: 49% vs 23%
Constipation
SYNCHRONIZE-MASLD at 6.0 mg: 28.1% vs 10.0% on placebo
Decreased appetite
SYNCHRONIZE-MASLD: 11.6% vs 10.0% on placebo. The most common drug-related effect in phase 1
Fatigue
SYNCHRONIZE-MASLD: 10.3% vs 5.7% on placebo
Stopping because of side effects
SYNCHRONIZE-MASLD: 23.3% vs 10.0% on placebo, with stomach effects behind 19.9% vs 4.3%. Type 2 diabetes phase 2: 12.9% of everyone treated stopped for an adverse event
How people manage it
- Phase 3 moved to slower, more flexible steps to help more people stay on.
Higher heart rate
SYNCHRONIZE-MASLD: up 3.6 beats per minute at week 52 vs 0.8 on placebo. Type 2 diabetes phase 2: up 2.3 to 7.3 beats per minute at 16 weeks
Lower blood pressure, light-headedness on standing
Phase 2 obesity at 4.8 mg: systolic down 8.6 mmHg vs 2.5 on placebo. Two orthostatic hypotension events on survodutide, none serious

Side effects users and guides report

What people post and what dosing guides list. These are reports, not measured rates.

From users and guides1

Community reports, competitor and vendor guides, media.

Vomiting, diarrhea or poor sleep when added to tirzepatide
No rate. Individual Reddit posters report vomiting or diarrhea after reaching about 2.4 mg on top of tirzepatide, and one reports worse insomnia
How people manage it
- Posters stopped the climb, dropped back a step or paused tirzepatide.

Who should avoid it, and what not to combine

Pregnancy and breastfeedingCondition
Not studied in these groups, so a guide says avoid.
Personal or family history of medullary thyroid cancer or MEN 2Condition
A standard warning for GLP-1 drugs that a guide applies to survodutide.
History of pancreatitisCondition
GLP-1 drugs carry a pancreas inflammation warning.
Insulin or sulfonylureasSubstance
Blood sugar may need close medical adjustment when either is combined with survodutide.
Known peptide allergyCondition
One phase 2 participant had angioedema, a serious swelling reaction.

How much is known

Strong human trials

Phase 1 studies, phase 2 trials in obesity (387 people), type 2 diabetes (411) and MASH (293), and phase 3 results from SYNCHRONIZE-1 (725), SYNCHRONIZE-2 (752) and SYNCHRONIZE-MASLD (216), published in 2026. Phase 3 MASH and cardiovascular outcome trials are still running. Grey-market vials, mixing from powder, and doses outside trial ladders have never been tested.