1. Salt and Water Retention
(see WARNINGS: Concomitant Use of Adequate Diuretic is Required)—Temporary edema developed in 7% of patients who were not edematous at the start of therapy.
2. Pericarditis, Pericardial Effusion, and Tamponade
Hypertrichosis—Elongation, thickening, and enhanced pigmentation of fine body hair are seen in about 80% of patients taking LONITEN Tablets. This develops within 3 to 6 weeks after starting therapy. It is usually first noticed on the temples, between the eyebrows, between the hairline and the eyebrows, or in the side-burn area of the upper lateral cheek, later extending to the back, arms, legs, and scalp. Upon discontinuation of LONITEN, new hair growth stops, but 1 to 6 months may be required for restoration to pretreatment appearance. No endocrine abnormalities have been found to explain the abnormal hair growth; thus, it is hypertrichosis without virilism. Hair growth is especially disturbing to children and women and such patients should be thoroughly informed about this effect before therapy with LONITEN is begun.
Allergic—Rashes have been reported, including rare reports of bullous eruptions, and Stevens-Johnson Syndrome.
Thrombocytopenia and leukopenia (WBC<3000/mm3) have rarely been reported.
Nausea and/or vomiting has been reported. In clinical trials the incidence of nausea and vomiting associated with the underlying disease has shown a decrease from pretrial levels.
Breast tenderness—This developed in less than 1% of patients.
7. Altered Laboratory Findings
- (a) ECG changes—Changes in direction and magnitude of the ECG T-waves occur in approximately 60% of patients treated with LONITEN. In rare instances a large negative amplitude of the T-wave may encroach upon the S-T segment, but the S-T segment is not independently altered. These changes usually disappear with continuance of treatment and revert to the pretreatment state if LONITEN is discontinued. No symptoms have been associated with these changes, nor have there been alterations in blood cell counts or in plasma enzyme concentrations that would suggest myocardial damage. Long-term treatment of patients manifesting such changes has provided no evidence of deteriorating cardiac function. At present the changes appear to be nonspecific and without identifiable clinical significance.
- (b) Effects of hemodilution—hematocrit, hemoglobin and erythrocyte count usually fall about 7% initially and then recover to pretreatment levels.
- (c) Other—Alkaline phosphatase increased varyingly without other evidence of liver or bone abnormality. Serum creatinine increased an average of 6% and BUN slightly more, but later declined to pretreatment levels.
REPORTS OF SUSPECTED LONITEN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Loniten. The information is not vetted and should not be considered as verified clinical evidence.
Possible Loniten side effects / adverse reactions in 65 year old female
Reported by a consumer/non-health professional from Brazil on 2011-10-31
Patient: 65 year old female weighing 65.0 kg (143.0 pounds)
Reactions: Renal Impairment, Hypertrichosis
Other drugs received by patient: Apresoline; Atenolol; Atensine; Levothyroxine Sodium