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.
ADVERSE REACTIONS Most adverse effects have been mild and transient.
The clinical adverse reactions listed in Table 1 represent data from Phase II/III placebo-controlled studies (306 patients given indapamide 1.25 mg).
The clinical adverse reactions listed in Table 2 represent data from Phase II placebo-controlled studies and long-term controlled clinical trials (426patients given indapamide 2.5 mg or 5.0 mg).
The reactions are arranged into two groups: 1) a cumulative incidence equal to or greater than 5%;
2)a cumulative incidence less than 5%.
Reactions are counted regardless of relation to drug.
TABLE 1: Adverse Reaction from Studies of 1.25mg Incidence ≥ 5% Incidence < 5%* BODY AS A WHOLE Headache Asthenia Infection Flu Syndrome Pain Abdominal Pain Back Pain Chest Pain GASTROINTESTINAL SYSTEM Constipation Diarrhea Dyspepsia Nausea METABOLIC SYSTEM Peripheral Edema CENTRAL NERVOUS SYSTEM Nervousness Dizziness Hypertonia RESPIRATORY SYSTEM Cough RHINITIS Pharyngitis Sinusitis SPECIAL SENSES Conjunctivitis *OTHER All other clinical adverse reactions occurred at an incidence of <1%.
Approximately 4% of patients given indapamide 1.25 mg compared to 5% of the patients given placebo discontinued treatment in the trials of up to eight weeks because of adverse reactions.
In controlled clinical trials of six to eight weeks in duration, 20% of patients receiving indapamide 1.25 mg, 61% of patients receiving indapamide 5.0 mg, and 80% of patients receiving indapamide 10.0 mg had at least one potassium value below 3.4 mEq/L.
In the indapamide 1.25 mg group, about 40% of those patients who reported hypokalemia as a laboratory adverse event returned to normal serum potassium values without intervention.
WARNINGS Severe cases of hyponatremia, accompanied by hypokalemia have been reported with recommended doses of indapamide.
This occurred primarily in elderly females.
(See PRECAUTIONS , Geriatric Use .) This appears to be dose related.
Also, a large case-controlled pharmacoepidemiology study indicates that there is an increased risk of hyponatremia with indapamide 2.5 mg and 5 mg doses.
Hyponatremia considered possibly clinically significant (< 125 mEq/L) has not been observed in clinical trials with the 1.25 mg dosage (see PRECAUTIONS ).
Like all medications, Indapamide 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: