FDA

Desmoda

Approved 25 Feb 2026OralSolution

Indications

DESMODA is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use

DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. DESMODA is a vasopressin analog indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use
DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus.

Contraindications

DESMODA is contraindicated in patients with:

Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)].
Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA.Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
Moderate to severe renal impairment (defined as creatinine clearance (CLcr) less than 50 mL/min)[see Use in Specific Populations (8.6)].
Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA. (4)
Patients with moderate to severe renal impairment defined as creatinine clearance below 50 mL/min. (4)
Patients with hyponatremia or a history of hyponatremia. (4)

Warnings and precautions

5.1Hyponatremia

Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated hyponatremia can be fatal. Observe all patients receiving DESMODA for the following signs or 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 due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma and/or respiratory arrest. In order to decrease the risk of water intoxication with hyponatremia, fluid restriction is recommended. Careful fluid intake is particularly important in pediatric and geriatric patients because these patients are at greater risk of developing hyponatremia [see Use in Specific Populations (8.4, 8.5)].

At a glance

Brand name: Desmoda
Active substance: desmopressin acetate
Route: Oral
Dosage form: Solution
Applicant: Eton
Status: Prescription
FDA approval: 25 Feb 2026
Application: NDA219873-001

Indications

DESMODA is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use

DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. DESMODA is a vasopressin analog indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use
DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus.

Contraindications

DESMODA is contraindicated in patients with:

Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)].
Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA.Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
Moderate to severe renal impairment (defined as creatinine clearance (CLcr) less than 50 mL/min)[see Use in Specific Populations (8.6)].
Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA. (4)
Patients with moderate to severe renal impairment defined as creatinine clearance below 50 mL/min. (4)
Patients with hyponatremia or a history of hyponatremia. (4)

Warnings and precautions

5.1Hyponatremia

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Available data on the use of desmopressin acetate during pregnancy over decades of use have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated central diabetes insipidus during pregnancy (see Clinical Considerations). In vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 to 38 times, respectively, the maximum recommended human dose based on body surface areas (mg/m2) (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease Associated Maternal and Embryo-Fetal Risk There are risks associated with untreated central diabetes insipidus during pregnancy such as dehydration, preterm birth and oligohydramnios.

Pregnant patients with diabetes insipidus should be monitored for electrolyte imbalance, maternal hypotension, and low amniotic fluid levels. Data Animal Data In a developmental toxicity study in rats, desmopressin acetate was administered intravenously at doses of 9.68, 48.4, or 241 mcg/kg/day during the period of organogenesis (gestations days 7 to 17). Laparohysterectomy for fetal examinations were conducted on gestation day 20 for twenty females in each group; the remaining 10 females were allowed to litter in order to determine any postnatal effects that might be attributable to pre-natal treatment.

No effects were seen on maternal and fetal survival, growth and morphology or post-natal offspring survival, growth, development, behavior and reproductive performance up to 241 mcg/kg/day (4 times a 0.6 mg dose received by a 60 kg patient based on body surface area). In an embryo-fetal development study and a pre- and postnatal development study in rabbits, desmopressin acetate was administered subcutaneously at doses of 2, 20 or 200 mcg/kg/day (embryo-fetal development) and 0.1, 1 or 10 mcg/kg/day (pre- and postnatal development) during the period of organogenesis (gestation days 6 to 18).

No effects on maternal and fetal survival or morphology were observed in both studies at doses of up to 200 mcg/kg/day (6.5 times a 0.6 mg dose received by a 60 kg patient based on body surface area) nor were there effects in the pre- and postnatal development study on parturition, postnatal survival, growth, development or behavior, up to the highest dose tested of 10 mcg/kg/day (0.3 times a 0.6 mg dose received by a 60 kg patient, based on body surface area).

Adverse reactions

The following serious adverse reactions are described below and elsewhere in the labeling:

Hyponatremia [see Warnings and Precautions (5.1)]
Fluid Retention [see Warnings and Precautions (5.2)]
Hypersensitivity [see Warnings and Precautions (5.3)]
Risk of Benzyl Alcohol Toxicity in Neonates [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of desmopressin acetate were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders: hypertension Gastrointestinal disorders: nausea, vomiting, diarrhea, constipation, abdominal cramps General disorders: headache, malaise, drug ineffective, edema, fatigue Hepatobiliary disorders: transient increases in AST (1.5 times the upper limit of normal) Immune system disorders: severe allergic reactions, anaphylaxis has occurred with other formulations of desmopressin Metabolism and nutrition: dehydration, hyponatremia, water intoxication with hyponatremia Nervous system disorders: hyponatremic convulsions, hyponatremic convulsions associated with concomitant use of the following medications: oxybutynin and imipramine [see Drug Interactions (7.1)], asthenia, coma, disturbance in attention, psychomotor hyperactivity, dizziness, somnolence, depressed level of consciousness, falls. Psychiatric disorders: confusional state, abnormal behavior, emotional disorder, depression, hallucination, insomnia Renal and urinary disorders: bladder and urethral symptoms, including urinary retention, urine flow decreased, dysuria Skin and subcutaneous tissue disorders: rash, dermatitis allergic, sweating, flushing, urticaria Respiratory, thoracic and mediastinal disorders: dyspnea, epistaxis In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate oral 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 the continued use of desmopressin acetate oral therapy. Most common adverse reactions include: headache, dizziness, nausea, abdominal pain, hypertension, and diarrhea. (6) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Desmoda

Indications

Contraindications

Warnings and precautions

5.1Hyponatremia

At a glance

Two medicines in one question?

Desmoda

Indications

Contraindications

Warnings and precautions

5.1Hyponatremia

At a glance

Two medicines in one question?

5.2Fluid Retention

5.3Hypersensitivity Reactions

5.4Risk of Benzyl Alcohol Toxicity in Neonates

Interactions

7.1Other

7.2Other Vasoconstrictors

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information