Desmopressin side effects: what 3,776 FDA adverse event reports show
Drug class
Vasopressin analog
Label matched
Desmopressin Acetate (Desmopressin Acetate)
Who reports
3,776 reports · 69% serious · 249 with death outcome · 56% female
Used for
Desmopressin acetate injection is a vasopressin analog used for: Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.
What it is
Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows: Mol. Wt. 1129.27 Empirical Formula: C 46 H 64 N 14 O .
Boxed warning
HYPONATREMIA Desmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions ( 5.1 )] . Desmopressin ace.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 153 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hyponatraemia (low sodium) | 357 | 35.5 32.1–39.2ROR 39.1 · χ² 11,887 / p <1e-300 | 35.2 EB05 32.2 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 29.4 | no trial data cached |
| Blood sodium decreased | 84 | 24.9 20.2–30.8ROR 25.5 · χ² 1,897 / p <1e-300 | 24.7 EB05 20.6 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 19.7 | no trial data cached |
| Emphysema | 29 | 16.0 11.1–22.9ROR 16.1 · χ² 391 / p 3e-87 | 15.6 EB05 11.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 0% (drug 56%) · 100% clinician | no trial data cached |
| Brain injury | 24 | 13.3 8.9–19.8ROR 13.4 · χ² 261 / p 7e-59 | 12.7 EB05 8.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · 96% clinician | no trial data cached |
| Electrolyte imbalance | 27 | 13.1 9.0–19.0ROR 13.1 · χ² 288 / p 6e-65 | 12.5 EB05 8.7 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.9 | no trial data cached |
| Thirst | 41 | 12.8 9.4–17.4ROR 12.9 · χ² 434 / p 1e-96 | 12.5 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Grand mal convulsion | 20 | 11.9 7.7–18.4ROR 11.9 · χ² 188 / p 4e-43 | 11.0 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Brain oedema | 26 | 11.5 7.8–16.8ROR 11.5 · χ² 237 / p 7e-54 | 10.8 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Adverse reaction | 27 | 11.3 7.8–16.5ROR 11.4 · χ² 243 / p 3e-55 | 10.6 EB05 7.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious n=26 · ♀ 4% (drug 56%) · 96% clinician | no trial data cached |
| Face oedema | 34 | 11.2 8.0–15.6ROR 11.3 · χ² 304 / p 2e-68 | 10.6 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 16% (drug 56%) · 94% clinician | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 19 | 10.4 6.6–16.3ROR 10.4 · χ² 152 / p 4e-35 | 9.3 EB05 6.0 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 | no trial data cached |
| Pneumothorax | 29 | 10.2 7.1–14.6ROR 10.2 · χ² 231 / p 2e-52 | 9.5 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · ♀ 0% (drug 56%) · 93% clinician | no trial data cached |
| Poor quality product administered | 17 | 9.2 5.8–14.9ROR 9.3 · χ² 117 / p 2e-27 | 8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Brain neoplasm | 14 | 8.5 5.0–14.3ROR 8.5 · χ² 85 / p 2e-20 | 7.1 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Nocturia (night-time urination) | 18 | 8.3 5.2–13.1ROR 8.3 · χ² 108 / p 2e-25 | 7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Epistaxis (nosebleed) | 99 | 7.3 6.0–8.9ROR 7.5 · χ² 537 / p 4e-119 | 7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Convulsion (seizure) | 75 | 7.2 5.7–9.0ROR 7.3 · χ² 394 / p 6e-88 | 6.9 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.2 | no trial data cached |
| Pollakiuria (frequent urination) | 50 | 6.7 5.1–8.8ROR 6.8 · χ² 236 / p 2e-53 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 72% consumer | no trial data cached |
| Contraindicated product administered | 35 | 6.4 4.6–9.0ROR 6.5 · χ² 156 / p 5e-36 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 97% clinician | no trial data cached |
| Product packaging quantity issue | 12 | 6.1 3.5–10.8ROR 6.1 · χ² 46 / p 5e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Anaphylactic shock | 28 | 6.1 4.2–8.8ROR 6.1 · χ² 114 / p 8e-27 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 4% (drug 56%) · 100% clinician | no trial data cached |
| Incontinence | 11 | 5.8 3.2–10.4ROR 5.8 · χ² 39 / p 2e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Muscle rigidity | 10 | 4.6 2.5–8.6ROR 4.7 · χ² 25 / p 3e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Cyst | 10 | 4.5 2.4–8.3ROR 4.5 · χ² 24 / p 6e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Drug prescribing error | 15 | 4.3 2.6–7.1ROR 4.3 · χ² 34 / p 2e-9 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Gastroenteritis | 11 | 4.2 2.3–7.6ROR 4.2 · χ² 24 / p 6e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Altered state of consciousness | 16 | 4.1 2.5–6.7ROR 4.1 · χ² 35 / p 2e-9 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Fear | 20 | 4.1 2.6–6.3ROR 4.1 · χ² 44 / p 2e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Gingival bleeding | 10 | 4.1 2.2–7.5ROR 4.1 · χ² 20 / p 4e-6 | 3.5 EB05 2.1 · IC025 +0.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.6 | no trial data cached |
| Flushing | 74 | 4.0 3.2–5.0ROR 4.1 · χ² 166 / p 3e-38 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Flatulence (gas) | 41 | 4.0 3.0–5.5ROR 4.1 · χ² 90 / p 1e-21 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 18% (drug 56%) | no trial data cached |
| Urinary retention | 24 | 4.0 2.7–6.0ROR 4.0 · χ² 51 / p 4e-13 | 3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.5 | no trial data cached |
| Anhedonia | 19 | 4.0 2.5–6.2ROR 4.0 · χ² 40 / p 2e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Menorrhagia (heavy periods) | 14 | 3.9 2.3–6.6ROR 3.9 · χ² 27 / p 8e-8 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Fluid retention | 35 | 3.8 2.8–5.3ROR 3.9 · χ² 70 / p 2e-17 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.8 | no trial data cached |
| Multi-organ failure | 12 | 3.8 2.2–6.7ROR 3.8 · χ² 22 / p 1e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Disorientation | 27 | 3.8 2.6–5.5ROR 3.8 · χ² 52 / p 2e-13 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Urinary incontinence | 20 | 3.8 2.4–5.8ROR 3.8 · χ² 38 / p 4e-10 | 3.5 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 37 | 3.7 2.7–5.2ROR 3.8 · χ² 72 / p 1e-17 | 3.6 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · ♀ 11% (drug 56%) · 97% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 11 | 3.7 2.1–6.7ROR 3.7 · χ² 19 / p 5e-6 | 3.3 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hyponatraemia (low sodium) | 357 | 35.5 32.1–39.2ROR 39.1 · χ² 11,887 / p <1e-300 | 35.2 EB05 32.2 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 29.4 | no trial data cached |
| Epistaxis (nosebleed) | 99 | 7.3 6.0–8.9ROR 7.5 · χ² 537 / p 4e-119 | 7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Blood sodium decreased | 84 | 24.9 20.2–30.8ROR 25.5 · χ² 1,897 / p <1e-300 | 24.7 EB05 20.6 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 19.7 | no trial data cached |
| Dehydration | 82 | 3.4 2.8–4.2ROR 3.5 · χ² 138 / p 3e-32 | 3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Seizure | 77 | 3.7 3.0–4.7ROR 3.8 · χ² 152 / p 4e-35 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.1 | no trial data cached |
| Convulsion (seizure) | 75 | 7.2 5.7–9.0ROR 7.3 · χ² 394 / p 6e-88 | 6.9 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.2 | no trial data cached |
| Flushing | 74 | 4.0 3.2–5.0ROR 4.1 · χ² 166 / p 3e-38 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Haemorrhage | 68 | 3.6 2.9–4.6ROR 3.7 · χ² 126 / p 1e-29 | 3.5 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · ♀ 33% (drug 56%) | no trial data cached |
| Product storage error | 57 | 3.7 2.8–4.7ROR 3.7 · χ² 108 / p 1e-25 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Migraine | 55 | 3.2 2.5–4.2ROR 3.3 · χ² 82 / p 6e-20 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 72% consumer | no trial data cached |
| Wrong technique in product usage process | 51 | 1.4 1.1–1.8ROR 1.4 · χ² 6 / p 0.009 | 1.4 EB05 1.1 · IC025 +0.0 | Reporting / coding artifact | serious PRR 4.9 · ♀ 77% (drug 56%) | no trial data cached |
| Pollakiuria (frequent urination) | 50 | 6.7 5.1–8.8ROR 6.8 · χ² 236 / p 2e-53 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 72% consumer | no trial data cached |
| Flatulence (gas) | 41 | 4.0 3.0–5.5ROR 4.1 · χ² 90 / p 1e-21 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 18% (drug 56%) | no trial data cached |
| Thirst | 41 | 12.8 9.4–17.4ROR 12.9 · χ² 434 / p 1e-96 | 12.5 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Lethargy | 38 | 3.7 2.7–5.0ROR 3.7 · χ² 71 / p 2e-17 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Emphysema — n=29, PRR 16.0
- Brain injury — n=24, PRR 13.3
- Thirst — n=41, PRR 12.8
- Grand mal convulsion — n=20, PRR 11.9
- Brain oedema — n=26, PRR 11.5
- Face oedema — n=34, PRR 11.2
- Pneumothorax — n=29, PRR 10.2
- Epistaxis — n=99, PRR 7.3
- Pollakiuria — n=50, PRR 6.7
- Anaphylactic shock — n=28, PRR 6.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Desmopressin?
In FDA FAERS, the most frequently co-reported reaction terms for Desmopressin are hyponatraemia, epistaxis, blood sodium decreased, dehydration, seizure, convulsion. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Desmopressin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: HYPONATREMIA Desmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions ( 5.1 )] . Desmopressin ace.
Do FAERS signals prove that Desmopressin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 1052a869-b64d-655d-e063-6294a90ad0e2, effective 20240322; matched on
openfda.generic_name.exact:"DESMOPRESSIN ACETATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 193 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.