DSIP side effects

How much safety data exists

DSIP has not been through the safety testing an approved drug needs.¹ FDA's 2026 review counted 209 people given it intravenously in published studies, each for 1 to 15 days.¹ All of that use was by intravenous infusion. FDA found no safety data at all for injection under the skin, the route proposed for compounded DSIP.¹

FDA also searched its adverse event reporting database (FAERS) through March 3, 2024 and found zero reports for emideltide, DSIP's official name.¹ An empty database is not evidence of safety. FDA's own conclusion is that safety for long-term, on-and-off use is insufficiently characterized.¹

Reported side effects at a glance

Serious reactions

The most serious reports come from a 1984 study of 107 inpatients going through alcohol or opiate withdrawal.⁸ FDA's review states that 3 of them had serious adverse effects. Two developed low blood pressure (hypotension) at the start of their first injection, and 1 had repeated episodes of discomfort with sweating and nausea.¹ One of the patients with low blood pressure was given a second injection, after which the hypotension was described as progressive; FDA had no further details.¹

These reports are hard to read.¹ FDA points out that withdrawal itself causes many of the same symptoms, which confounds any judgment about the drug.¹ The study also lacked blinding and a comparison group, so it cannot show how often such reactions would happen without DSIP.¹

Mild and short-lived effects

The early Swiss studies described DSIP as well tolerated.⁵⁷ The 1981 report on 6 healthy volunteers stated that no psychological, physiological or biochemical side effects were observed.⁵ FDA's 2026 summary table for the same study, however, lists warmth, heaviness, dry mouth, deep breathing and headache, including 1 case of prolonged headache.² The two accounts do not match.

Other studies add a few more reports. A 1983 paper covering five double-blind studies called DSIP's compatibility good, while FDA's table lists headache for that series of 20 people.⁷⁴ FDA's table lists mild drowsiness for a 1987 insomnia study of 6 people.³ In the 1984 withdrawal study, 9 of 107 patients had minor, short-lived sweating, headache, nausea or vertigo.¹ The study's own abstract rated tolerance as good, apart from headaches reported by a few patients.⁸

Some effects relate to sleep itself.¹⁶ Right after the infusion, 5 of 6 healthy volunteers reported a feeling of pressure to sleep.¹ In adults with chronic insomnia, a slight arousing effect showed up in the first hour, and sleep effects started only in the second hour.⁶

Effects during anesthesia

In a 2009 randomized trial, 24 women having isoflurane anesthesia received either saline or DSIP by intravenous bolus, once while awake and again under anesthesia.⁹ DSIP raised heart rate and lowered heart rate variability; against expectation, at 25 nmol/kg it reduced delta brain waves and made anesthesia lighter rather than deeper.⁹ The authors concluded that DSIP probably reduced parasympathetic tone.⁹

Warnings from FDA's review

• Immune reactions: FDA says compounded emideltide may pose a risk of immunogenicity, an unwanted immune response, for certain routes.¹⁰ Its review adds that injection under the skin is generally linked to more immune reactions than intravenous dosing.¹
• Clumping and impurities: as a peptide of 9 amino acids, DSIP may form aggregates and carry peptide-related impurities, which FDA says could amplify that immune risk.¹
• Missing toxicity studies: FDA identified no repeat-dose toxicity studies, no developmental or reproductive studies and no 2-year cancer studies, so effects in pregnancy and with long-term use are unknown.¹
• Abuse potential: DSIP appears to act partly through the opioid system, and FDA found no studies of whether it can cause addiction.¹
• Drug interactions: based on cell studies, FDA notes that medicines which block dipeptidase enzymes, such as the blood pressure drug captopril, might slow DSIP's breakdown and raise its levels.¹
• Product identity: FDA reports that products sold as DSIP have contained different salts and even entirely different active substances, and none of the websites it reviewed said which form they sold.¹
• Quality testing: according to FDA, the certificate of analysis filed with the compounding nomination listed no bioburden (microbe count) or endotoxin test.¹

FDA sums up the gap plainly: it lacks the information to know whether compounded emideltide would cause harm if given to people.¹⁰

Related pages

The full profile is What is DSIP?. The study doses behind these reports are in DSIP dosage, and what the same studies found is in DSIP benefits and uses. For how to weigh safety data on any research peptide, see Peptide safety basics.