Minirin Adverse Reactions

Tablet: Tabulated Summary of Adverse Reactions: Adults: Based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in adults for treatment of Nocturia (N=1557) combined with the post marketing experience for all adult indications (incl Central Diabetes Insipidus). Reactions only seen post marketing have been added in the 'Not known'-frequency column. (See Table 2.)

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Children and adolescents: Based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in children and adolescents for treatment of Primary Nocturnal Enuresis (N=1923). Events only seen in post marketing have been added in the 'Not known' frequency column. (See Table 3.)

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Other Special Populations: Elderly patients and patients with serum sodium levels in the lower range of normal may have an increased risk of developing hyponatraemia (see Precautions).
Oral lyophilisate: Adults: Based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in adults for treatment of nocturia (n=1557) combined with the post-marketing experience for all adult indications (including central diabetes insipidus). Reactions only seen in post-marketing have been added in the "Not known"-frequency column.
MedDRA Organ Class: Very common (>10%); common (1-10%); uncommon (0.1-1%); rare (0.1-0.01%); Not known.
Immune System Disorders: Not Known: Anaphylactic reaction.
Metabolism and Nutrition Disorders: Common: Hyponatraemia^*. Not Known: Dehydration^**, hypernatraemia^**.
Psychiatric Disorders: Uncommon: Insomnia. Rare: Confusional state^*.
Nervous System Disorders: Very Common: Headache^*. Common: Dizziness*. Uncommon: Somnolence, paraesthesia. Not Known: Convulsions^*, asthenia^**, coma^*.
Eye Disorders: Uncommon: Visual impairment.
Ear and Labyrinth Disorders: Uncommon: Vertigo^*.
Cardiac Disorders: Uncommon: Palpitations.
Vascular Disorders: Common: Hypertension. Uncommon: Orthostatic hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnoea.
Gastrointestinal Disorders: Common: Nausea^*, abdominal pain^*, diarrhoea, constipation, vomiting*. Uncommon: Dyspepsia, (HLT) flatulence, bloating, distention.
Skin and Subcutaneous Tissue Disorders: Uncommon: Sweating, pruritus, rash, urticaria. Rare: Allergic dermatitis.
Musculoskeletal and Connective Tissue Disorders: Common: Myalgia. Uncommon: Muscle spasms.
Renal and Urinary Disorders: (HLT) Bladder and urethral symptoms.
General Disorders and Administration Site Conditions: Common: (HLT) Oedema, fatigue. Uncommon: Malaise*, chest pain, influenza-like illness.
Investigations: Uncommon: Increased weight, increased hepatic enzyme, hypokalaemia.
^*Hyponatraemia may cause headache, abdominal pain, nausea, vomiting, increased weight, dizziness, confusion, malaise, memory impairment, vertigo, falls and in severe cases, convulsions and coma.
^**Only seen in the CDI indication.
Based on the frequency of adverse drug reactions reported in clinical trials conducted in children and adolescents with oral desmopressin for treatment of Primary Nocturnal Enuresis (n=1923). Reactions only seen in post-marketing have been added in the "Not known" - frequency column'.
MedDRA Organ Class: Very common (>10%); common (1-10%); uncommon (0.1-1%); rare (0.1-0.01%); Not known.
Immune System Disorders: Not Known: Anaphylactic reaction.
Metabolism and Nutrition Disorders: Not Known: Hyponatraemia^*.
Psychiatric Disorders: Uncommon: Affect lability^**, aggression^***. Rare: (HLT) Anxiety symptoms, nightmare^*, mood swings^****. Not Known: Abnormal behaviour, emotional disorder, depression, hallucination, insomnia.
Nervous System Disorders: Common: Headache^*. Rare: Somnolence. Not Known: Attention disturbance, psychomotor hyperactivity, convulsions^*.
Vascular Disorders: Rare: Hypertension.
Respiratory, Thoracic and Mediastinal Disorders: Not Known: Epistaxis.
Gastrointestinal Disorders: Uncommon: Abdominal pain^*, nausea^*, vomiting^*, diarrhoea.
Skin and Subcutaneous Tissue Disorders: Not Known: Allergic dermatitis, rash, sweating, urticaria.
Renal and Urinary Disorders: (HLT) Bladder and urethral symptoms.
General Disorders and Administration Site Conditions: Uncommon: Peripheral oedema, fatigue. Rare: Irritability.
^*Hyponatraemia may cause headache, abdominal pain, nausea, vomiting, increased weight, dizziness, confusion, malaise, memory impairment, vertigo, falls and in severe cases, convulsions and coma.
^**Post-marketing reported equally in children and adolescents (<18 years).
^***Post-marketing almost exclusively reported in children and adolescents (<18 years).
^****Post-marketing reported primarily in children (<12 years).
Injection: Summary of the safety profile: The most frequently reported adverse reaction with MINIRIN injection during post marketing is hyponatraemia. Hyponatraemia may cause headache, nausea, vomiting, water intoxication, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness, generalized or local oedemas (peripheral, face), and in severe cases brain oedema, hyponatraemic encephalopathy, convulsions, and coma (see Precautions).
Rare cases of serious hypersensitivity reactions including anaphylactoid shock and reaction have been reported in association with MINIRIN injection (see Precautions).
Tabulated list of adverse reactions: The table as follows is based on the frequency of adverse drug reactions reported in clinical trials with MINIRIN injection conducted in adults for treatment of central diabetes insipidus and haematological indications (N=53) and OCTOSTIM injections (n=76), combined with the post marketing experience for MINIRIN/OCTOSTIM injections. Reactions only seen in post marketing or in other desmopressin formulations have been added in the 'Not known' frequency column. The table as follows shows the frequencies of adverse reactions reported. Adverse reactions are classified according to frequency and system organ class. Frequency categories are defined according to the following convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000) and Not known (cannot be estimated from the available data). (See Table 4.)

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Description of selected adverse reactions: During post-marketing the most frequently reported adverse reaction with MINIRIN/OCTOSTIM injection is hyponatraemia. Hyponatraemia may cause headache, nausea, vomiting, water intoxication, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusional state, decreased consciousness, generalized or local oedemas (peripheral, face), and in severe cases brain oedema, hyponatraemic encephalopathy, convulsions, and coma. Nausea, vomiting, headache and dizziness have been reported without registered hyponatraemia. The hyponatraemia is a result of the antidiuretic effect, arising from increased water reabsorption by the renal tubules and osmotic dilution of plasma. Special attention should be paid to the precautions addressed in Warnings and Precautions.
Hyponatraemia is reversible. Treatment should be individualised and rapid overcorrection should be avoided to reduce the risk of further complications (see Dosage & Administration and Precautions).
Post-marketing hypersensitivity reactions including local allergic reactions such as dyspnoea, erythema, generalized or local oedemas (peripheral, face), pruritus, rash, rash macular, rash maculopapular, rash erythematous, skin plaque and urticaria, have been reported in association with MINIRIN/OCTOSTIM injection. More serious hypersensitivity reactions including anaphylactic shock and reaction, and anaphylactoid shock and reaction have also been reported in association with MINIRIN/OCTOSTIM injection. Allergic reactions usually occur rapidly after drug administration and may occur during first time usage or after repeated exposure of MINIRIN/OCTOSTIM injection.
Rare post-marketing cases of deep vein thrombosis, cerebrovascular accident/disorder (stroke), cerebral thrombosis, pulmonary embolism, myocardial infarction, angina pectoris and chest pain have been reported in patients treated with desmopressin. Due to confounding factors and/or missing information, a causal relationship with MINIRIN/OCTOSTIM injection has not been established/confirmed.
Paediatric population: Adverse reaction data from clinical trials in children is very limited.
Other special populations: Elderly and patients with serum sodium levels in the lower range of normal may have an increased risk of developing hyponatraemia (see Precautions).
Nasal Spray: Summary of the safety profile: The most serious adverse reaction with desmopressin is hyponatraemia, see "Description of selected adverse reactions".
The most commonly reported adverse reactions during treatment were nasal congestion (27%), high body temperature (15%) and rhinitis (12%). Other common adverse reactions were headache (9%), upper respiratory tract infection (9%), gastroenteritis (7%), abdominal pain (5%). Anaphylactic reactions have not been seen in clinical trials but spontaneous reports have been received.
Tabulated summary of adverse reactions: The following table is based on the frequency of adverse drug reactions reported in clinical trials with nasal MINIRIN conducted in children and adults for treatment of central diabetes insipidus, primary nocturnal enuresis and at testing of renal concentration capacity (N=745) combined with the post marketing experience for all indications. Reactions only reported post-marketing or for other desmopressin formulations have been added in the "Not known" frequency column. (See Table 5.)

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Description of selected adverse reactions: The most serious adverse reaction with desmopressin is hyponatraemia, which may give symptoms like headache, nausea, vomiting, weight increase, malaise, abdominal pain, muscle spasms, dizziness, confusion, decreased consciousness and in serious cases convulsions and coma. The cause of the potential hyponatraemia is the anticipated antidiuretic effect.
Paediatric population: Hyponatraemia is reversible and in children it is often seen to occur in relation to changes in daily routines affecting fluid intake and/or perspiration.
Special precautions should be observed in children, see Precautions.
Special populations: Elderly patients and patients with low serum sodium levels may have an increased risk of developing hyponatraemia (see Precautions).