Desmopressin is a small synthetic peptide that makes the kidneys hold water. Almost everything on its side-effect list follows from that one action, and the most serious item — low blood sodium, or hyponatremia — is not a rare oddity but the drug working too well.
This page reports what the US labels count, form by form, with their dates. The structural reasons desmopressin behaves so differently from the natural hormone are on our desmopressin vs vasopressin comparison; the labelled doses by route are on our desmopressin dosage page; Peptide Lexicon's desmopressin entry explains the molecule. Nothing here is advice on starting, stopping or changing a dose — that sits with the prescriber.
The warning on top: hyponatremia
The originator's injection label, DDAVP Injection (Ferring, September 2022), opens with a boxed warning: desmopressin "can cause hyponatremia", and severe hyponatremia "can be life-threatening, leading to seizures, coma, respiratory arrest, or death". The same box contraindicates the drug in people at higher risk — excessive fluid intake, illnesses that upset fluid or electrolyte balance, loop diuretics, systemic or inhaled glucocorticoids — and sets the checks: sodium normal before starting, measured within 7 days and at about one month, and more often from age 65.
The older DDAVP tablet label (February 2021) lists the symptoms that can signal it: headache, nausea or vomiting, weight gain, restlessness, fatigue, lethargy, disorientation, muscle cramps, confusion, and in severe cases seizure, coma or respiratory arrest. Those early symptoms overlap with the drug's ordinary side effects, which is part of why the labels rely on a blood test rather than on symptoms.
The only placebo-controlled sodium counts
Most desmopressin labels list reactions from postmarketing reports, without rates. Two approvals are the exception: the products built for night-time urination in adults, Noctiva (nasal spray, approved March 2017) and Nocdurna (sublingual tablet, approved June 2018). Both are now listed as discontinued on Drugs@FDA, but their labels remain on file and carry the clearest numbers anywhere on the drug.
Noctiva — two placebo-controlled trials (label March 2017)
| Serum sodium (mmol/L) | 1.66 mcg (n=341) | 0.83 mcg (n=354) | Placebo (n=349) |
|---|---|---|---|
| 130–134 | 42 (12.3%) | 33 (9.3%) | 18 (5.2%) |
| 126–129 | 7 (2.1%) | 8 (2.3%) | 0 |
| 125 or below | 5 (1.5%) | 0 | 1 (0.3%) |
All five people on the higher dose whose sodium reached 125 or below were 65 or older, four were men, onset ranged from 6 days to 12 weeks, four were also on a systemic or inhaled glucocorticoid and three on an NSAID — two drug classes the label goes on to flag.
Nocdurna — pooled phase 3 trials, by sex and age (label June 2018)
| Sodium (mmol/L) | Women <65, 27.7 mcg (n=113) | Women ≥65, 27.7 mcg (n=78) | Men <65, 55.3 mcg (n=98) | Men ≥65, 55.3 mcg (n=94) | Men ≥65, placebo (n=112) |
|---|---|---|---|---|---|
| 130–134 | 4 (4%) | 9 (12%) | 11 (11%) | 22 (23%) | 1 (<1%) |
| 126–129 | 2 (2%) | 5 (6%) | 0 | 1 (1%) | 0 |
| 125 or below | 0 | 0 | 0 | 3 (3%) | 0 |
Adding the rows: 26 of 94 men aged 65 and over on 55.3 mcg (27%) recorded a sodium below 135 mmol/L at some visit, against 1 of 112 on placebo. Among women 65 and over on the lower dose the figure was 14 of 78 (18%). That is our arithmetic from the label's own table; the label counts any post-baseline value below the normal range, not the share of time spent there. Nocdurna was approved with a lower dose for women because women showed greater sensitivity to its antidiuretic effect.
The other side effects, by form
Nocdurna, reactions above 2% and above placebo (pooled trials, label June 2018):
| Reaction | Women, placebo (n=173) | Women, 27.7 mcg (n=196) | Men, placebo (n=213) | Men, 55.3 mcg (n=195) |
|---|---|---|---|---|
| Dry mouth | 19 (11%) | 23 (12%) | 27 (13%) | 27 (14%) |
| Low sodium | 3 (2%) | 6 (3%) | 1 (<1%) | 8 (4%) |
| Headache | 5 (3%) | 4 (2%) | 3 (1%) | 7 (4%) |
| Dizziness | 0 | 3 (2%) | 1 (<1%) | 5 (3%) |
The label notes that dry mouth was asked about directly in one trial; where it was reported spontaneously, it ran at 4% or less.
Noctiva, reactions at 2% or more and above placebo (label March 2017): nasal discomfort 5.9% (placebo 4.9%), nasopharyngitis 3.8% (2.9%), nasal congestion 2.9% (1.4%), sneezing 2.6% (1.4%), raised blood pressure 2.6% (1.1%), back pain 2.3% (0.9%), nosebleed 2.1% (1.1%), bronchitis 2.1% (0.9%). Two people on the higher dose stopped because of atrial fibrillation, none on placebo.
Tablets (DDAVP, February 2021): in the controlled bedwetting trials, the only adverse event at 3% or more judged possibly related was headache — 4% on desmopressin, 3% on placebo. In diabetes insipidus patients followed up to 44 months, transient AST rises no higher than 1.5 times normal were "occasionally observed" and returned to normal on continued treatment.
Nasal sprays (generic labels 2021–2025; Stimate July 2026): listed from postmarketing use without rates — headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, abdominal cramps, raised blood pressure, and severe allergic reactions including anaphylaxis. Stimate's 2026 label adds tachycardia, palpitations, eye redness and light sensitivity, and marks fatigue, swelling, weight gain, nausea and confusion as reported in association with low sodium.
Injection (DDAVP, September 2022): postmarketing hypertension, hypotension, tachycardia, thrombotic events, fluid retention, nausea, abdominal cramps, hypersensitivity, redness, swelling and burning pain at the site, facial flushing, headache and hyponatremic seizures. Separate warnings cover blood-pressure changes and a thrombosis risk in type IIB von Willebrand disease. Injection-site reactions in general are covered on our peptide injection-site reactions page.
Why the spray lost its bedwetting indication
Current desmopressin nasal spray labels state, in their limitations of use, that the spray is not indicated for primary nocturnal enuresis, and give the reason in the warnings: postmarketing reports showed "a higher risk of hyponatremia and hyponatremic convulsions with the use of the nasal spray formulation compared to desmopressin tablets". The tablet label keeps the bedwetting indication. Noctiva's label went further and contraindicated itself in primary nocturnal enuresis outright.
Drug combinations the labels name
The labels list two sets. Contraindicated because the combination raises the risk of severe hyponatremia: loop diuretics and systemic or inhaled glucocorticoids. Monitor sodium more often because they also promote water retention: tricyclic antidepressants, SSRIs, chlorpromazine, opioid analgesics, NSAIDs, lamotrigine and carbamazepine (Noctiva label). The tablet and spray labels add rare reports of hyponatremic convulsions with oxybutynin and imipramine.
What FDA's adverse-event database holds
On 28 October 2026, openFDA's adverse event endpoint returned 3,748 reports naming desmopressin as a suspect drug (database updated 30 July 2026). The most frequent reaction terms were hyponatraemia (344), headache (268), "drug ineffective" (257), nausea (193), fatigue (173), vomiting (153), off-label use (144), dizziness (129) and nosebleed (99). These are voluntary reports, not rates: a report does not establish that the drug caused the event, and the number of people exposed is unknown.
What is not established
- Rates for the main US indications. The diabetes insipidus and bleeding-disorder labels list reactions without placebo-controlled frequencies; the clearest numbers come from nocturia trials in adults 50 and over, which do not transfer directly to other uses.
- Long-term sodium patterns beyond the trial windows — Noctiva's open-label extension ran up to 126 weeks and reported no overall change, but without a control group.
- Any safety record for desmopressin sold online as a research peptide. Those products carry no label and no quality record; our guide to reading a certificate of analysis explains what a seller's document can and cannot show.
Symptoms that can mean low sodium — headache, nausea, confusion, unusual tiredness — while on desmopressin are a reason to contact the prescribing clinician promptly. Desmopressin's place among other approved peptide drugs is on our FDA-approved peptides list, and the wider pattern of boxed warnings across the class is on are peptides safe.
Sources and dates
- DDAVP Injection prescribing information (Ferring), September 2022, and DDAVP Tablets, February 2021, via openFDA — read 28 October 2026.
- Desmopressin acetate nasal spray labels (Oceanside, June 2025; Bausch & Lomb, September 2021) and Stimate (Ferring, July 2026), via openFDA — read 28 October 2026.
- Nocdurna prescribing information, NDA 022517, June 2018 (accessdata.fda.gov label PDF) — tables 1–4, read 28 October 2026.
- Noctiva prescribing information, NDA 201656, March 2017 (accessdata.fda.gov label PDF) — tables 1–4 and section 7, read 28 October 2026.
- Drugs@FDA via openFDA: Nocdurna and Noctiva marketing status (both discontinued) — read 28 October 2026.
- openFDA drug adverse event API: reports with desmopressin as suspect drug, count by reaction term — queried 28 October 2026 (data to 30 July 2026).