pharmacopeia
2D structure
(2S)-N-[(2R)-1-[(2-amino-2-oxoethyl)amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]-1-[(4R,7S,10S,13S,16S)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carbonyl]pyrrolidine-2-carboxamide
SMILES C1C[C@H](N(C1)C(=O)[C@@H]2CSSCCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N2)CC(=O)N)CCC(=O)N)CC3=CC=CC=C3)CC4=CC=C(C=C4)O)C(=O)N[C@H](CCCN=C(N)N)C(=O)NCC(=O)N
InChIKey NFLWUMRGJYTJIN-PNIOQBSNSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Pituitary Hormone Receptor Agonists.

Pituitary Hormone Receptor

Indications

Sourced from openFDA
  • Central Diabetes Insipidus Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus.

Contraindications

Sourced from openFDA
  • Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. Desmopressin acetate tablets are contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min).contraindicated

Dosage & administration

Sourced from openFDA

Central Diabetes Insipidus The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of desmopressin acetate tablet therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover. Fluid restriction should be observed. (See WARNINGS , PRECAUTIONS, Pediatric Use and Geriatric Use .) Adults and Children It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis.

Warnings & precautions

Sourced from openFDA

Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated desmopressin acetate. Desmopressin acetate is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required. When desmopressin acetate tablets are administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. (See PRECAUTIONS, Pediatric Use and Geriatric Use .) All patients receiving desmopressin acetate tablets therapy should be observed for the following signs of symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.

Adverse reactions

Sourced from openFDA

Infrequently, large doses of the intranasal formulations of desmopressin acetate tablets and injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage. Central Diabetes Insipidus In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of desmopressin acetate tablets. Primary Nocturnal Enuresis The only adverse event occurring in ≥3% of patients in controlled clinical trials with desmopressin acetate tablets that was probably, possibly, or remotely related to study drug was headache (4% desmopressin acetate, 3% placebo). Other The following adverse events have been reported; however their relationship to desmopressin acetate has not been established: abnormal thinking, diarrhea, and edema-weight gain. See WARNINGS for the possibility of water intoxication and hyponatremia. Post Marketing There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

Use in specific populations

Sourced from openFDA

Pregnancy Category B Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to desmopressin acetate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Several publications where desmopressin acetate was used in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and desmopressin acetate has been established. A fifteen year Swedish epidemiologic study of the use of desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however, the statistical power of this study is low. As opposed to preparations containing natural hormones, desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the possible therapeutic advantages against the possible risks in each case.

Overdosage

Sourced from openFDA

Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. (See WARNINGS .) In case of overdose, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for desmopressin acetate. The patient should be observed and treated with appropriate symptomatic therapy. An oral LD 50 has not been established. Oral doses up to 0.2 mg/kg/day have been administered to dogs and rats for 6 months without any significant drug-related toxicities reported. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

Approval history

Sourced from openFDA
  • Mar 30, 1984NDANDA018938Nordic Pharma
  • Sep 6, 1995NDANDA019955Ferring Pharms Inc
  • Oct 15, 1997ANDAANDA074888Meitheal
  • Jan 25, 1999ANDAANDA074830Bausch
  • Jan 27, 2005ANDAANDA076703Apotex
  • Mar 7, 2006ANDAANDA077414Apotex
  • Jan 25, 2013ANDAANDA091280Sun Pharm Inds Ltd
  • Feb 25, 2026NDANDA219873Eton

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,238 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Hyponatraemia33510%
  2. 2Drug Ineffective2166.7%
  3. 3Headache1845.7%
  4. 4Nausea1715.3%
  5. 5Fatigue1434.4%
  6. 6Vomiting1374.2%
  7. 7Off Label Use1324.1%
  8. 8Dizziness1123.5%
  9. 9Diarrhoea1083.3%
  10. 10Pain1043.2%
  11. 11Asthenia973.0%
  12. 12Malaise852.6%
  13. 13Pyrexia852.6%
  14. 14Dyspnoea832.6%
  15. 15Fall812.5%

Literature

View JSON

Recent PubMed references pinned to Desmopressin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 123 ClinicalTrials.gov registrations naming Desmopressin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Desmopressin work?
Mechanism-of-action class: Pituitary Hormone Receptor Agonists.
What is Desmopressin used for?
According to FDA labeling, Desmopressin carries indications including: Central Diabetes Insipidus Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Desmopressin?
Desmopressin is classified as Vasopressin and analogues, Factor VIII Activator, Vasopressin Analog, Pituitary Hormone Receptor Agonists, Decreased Coagulation Factor Activity, Increased Coagulation Factor Concentration, Increased Coagulation Factor VIII Activity, Increased Coagulation Factor VIII Concentration, Increased Collecting Duct Water Permeability.
What are the brand names for Desmopressin?
Desmopressin is marketed under brand names including DDAVP, Desmoda, Nocdurna, Noctiva.
What are the contraindications for Desmopressin?
Desmopressin labeling lists contraindications including: Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. Desmopressin acetate tablets are contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min).. Always consult the full prescribing information and a clinician.
Note. Data for desmopressin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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