Lozol Side Effects
Generic Name: Indapamide
Please note - some side effects for Lozol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Lozol - for the consumer
Lozol
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lozol:
Seek medical attention right away if any of these SEVERE side effects occur when using Lozol:Back pain; diarrhea; dizziness or lightheadedness when siting up or standing; headache; infection; nervousness; pain; runny nose; trouble sleeping; upset stomach.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; drowsiness; fatigue; irregular heartbeat; muscle cramps; numbness of your hands or feet; pounding in the chest; rapid heartbeat; unusual tiredness; urination problems; weakness; yellowing of the skin or eyes.
For the professional
Lozol
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 (426 patients given Lozol 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.
| 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 |
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. Hypokalemia with concomitant clinical signs or symptoms occurred in 2% of patients receiving indapamide 1.25 mg.
| Incidence ≥ 5% | Incidence < 5% |
|---|---|
| CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR | |
| Headache | Lightheadedness |
| Dizziness | Drowsiness |
| Fatigue, weakness, loss | Vertigo |
| of energy, lethargy, tiredness, or malaise | Insomnia |
| Muscle cramps or | Depression |
| spasm, or numbness of the extremities | Blurred Vision |
| Nervousness, tension, | |
| anxiety, irritability, or agitation | |
| GASTROINTESTINAL SYSTEM | Constipation |
| Nausea | |
| Vomiting | |
| Diarrhea | |
| Gastric irritation | |
| Abdominal pain or cramps | |
| Anorexia | |
| CARDIOVASCULAR SYSTEM | Orthostatic hypotension |
| Premature ventricular contractions | |
| Irregular heart beat | |
| Palpitations | |
| GENITOURINARY SYSTEM | Frequency of urination |
| Nocturia | |
| Polyuria | |
| DERMATOLOGIC/ HYPERSENSITIVITY | Rash |
| Hives | |
| Pruritus | |
| Vasculitis | |
| OTHER | Impotence or reduced libido |
| Rhinorrhea | |
| Flushing | |
| Hyperuricemia | |
| Hyperglycemia | |
| Hyponatremia | |
| Hypochloremia | |
| Increase in serum urea nitrogen | |
| (BUN) or creatinine | |
| Glycosuria | |
| Weight loss | |
| Dry mouth | |
| Tingling of extremities | |
Because most of these data are from long-term studies (up to 40 weeks of treatment), it is probable that many of the adverse experiences reported are due to causes other than the drug. Approximately 10% of patients given indapamide discontinued treatment in long-term trials because of reactions either related or unrelated to the drug.
Hypokalemia with concomitant clinical signs or symptoms occurred in 3% of patients receiving indapamide 2.5 mg q.d. and 7% of patients receiving indapamide 5 mg q.d. In long-term controlled clinical trials comparing the hypokalemic effects of daily doses of indapamide and hydrochlorothiazide, however, 47% of patients receiving indapamide 2.5 mg, 72% of patients receiving indapamide 5 mg, and 44% of patients receiving hydrochlorothiazide 50 mg had at least one potassium value (out of a total of 11 taken during the study) below 3.5 mEq/L. In the indapamide 2.5 mg group, over 50% of those patients returned to normal serum potassium values without intervention.
In clinical trials of six to eight weeks, the mean changes in selected values were as shown in the tables below.
| Mean Changes from Baseline after 8 Weeks of Treatment – 1.25 mg | |||||
|---|---|---|---|---|---|
| Serum Electrolytes (mEq/L) Potassium Sodium Chloride |
Serum Uric Acid (mg/dL) |
BUN (mg/dL) |
|||
| Indapamide 1.25 mg (n=255–257) |
– 0.28 | – 0.63 | – 2.60 | 0.69 | 1.46 |
| Placebo (n=263–266) |
0.00 | – 0.11 | – 0.21 | 0.06 | 0.06 |
No patients receiving indapamide 1.25 mg experienced hyponatremia considered possibly clinically significant (<125 mEq/L).
Indapamide had no adverse effects on lipids.
| Mean Changes from Baseline after 40 Weeks of Treatment – 2.5 mg and 5.0 mg | |||||
|---|---|---|---|---|---|
| Serum Electrolytes (mEq/L) Potassium Sodium Chloride |
Serum Uric Acid (mg/dL) |
BUN (mg/dL) |
|||
| Indapamide 2.5 mg (n=76) |
– 0.4 | – 0.6 | – 3.6 | 0.7 | – 0.1 |
| Indapamide 5.0 mg (n=81) |
– 0.6 | – 0.7 | – 5.1 | 1.1 | 1.4 |
The following reactions have been reported with clinical usage of Lozol: jaundice (intrahepatic cholestatic jaundice), hepatitis, pancreatitis and abnormal liver function tests. These reactions were reversible with discontinuance of the drug.
Also reported are erythema multiforme, Stevens-Johnson Syndrome, bullous eruptions, purpura, photosensitivity, fever, pneumonitis, anaphylactic reactions, agranulocytosis, leukopenia, thrombocytopenia and aplastic anemia. Other adverse reactions reported with antihypertensive/diuretics are necrotizing angiitis, respiratory distress, sialadenitis, xanthopsia.
TopMore resources:
Lozol - Includes detailed dosage instructions.
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