Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 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.
5 WARNINGS AND PRECAUTIONS 5.1 Hyponatremia 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.
Like all medications, Desmoda can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: