Renitec Side Effects

RENITEC has been demonstrated to be generally well tolerated. In clinical studies, the overall incidence of side effects was no greater with RENITEC than with placebo. For the most part, side effects have been mild and transient in nature, and have not required discontinuation of therapy.
The following side effects have been associated with the use of Tablets RENITEC: Dizziness and headache were the more commonly reported side effects. Fatigue and asthenia were reported in 2-3% of patients. Other side effects occurred in less than 2% of patients, and included hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle cramps, rash, and cough. Less frequently renal dysfunction, renal failure, and oliguria have been reported.
Hypersensitivity/Angioneurotic Edema: Angioneurotic edema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely (see PRECAUTIONS). In very rare cases, intestinal angioedema has been reported with angiotensin converting enzyme inhibitors including enalapril.
Side effects which occurred very rarely, either during controlled clinical trials or after the drug was marketed, include: CARDIOVASCULAR: myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see PRECAUTIONS), chest pain, palpitations, rhythm disturbances, angina pectoris, Raynaud's phenomenon.
ENDOCRINE: syndrome of inappropriate antidiuretic hormone secretion (SIADH).
GASTROINTESTINAL: ileus, pancreatitis, hepatic failure, hepatitis - either hepatocellular or cholestatic, jaundice, abdominal pain, vomiting, dyspepsia, constipation , anorexia, stomatitis.
METABOLIC: Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported (see INTERACTIONS).
NERVOUS SYSTEM/ PSYCHIATRIC: depression, confusion, somnolence, insomnia, nervousness, paresthesia, vertigo, dream abnormality.
RESPIRATORY: pulmonary infiltrates, bronchospasm/asthma, dyspnea, rhinorrhea, sore throat and hoarseness.
SKIN: diaphoresis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal, necrolysis, pemphigus, pruritus, urticaria, alopecia.
OTHER: impotence, flushing, taste alteration, tinnitus, glossitis, blurred vision.
A symptom complex has been reported which may include some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, a positive ANA, elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity or other dermatologic manifestations may occur.
LABORATORY TEST FINDINGS: Clinically important changes in standard laboratory parameters were rarely associated with administration of RENITEC. Increases in blood urea and serum creatinine, and elevations of liver enzymes and/or serum bilirubin have been seen. These are usually reversible upon discontinuation of RENITEC. Hyperkalemia and hyponatremia have occurred.
Decreases in hemoglobin and hematocrit have been reported.
Since the drug was marketed a small number of cases of neutropenia, thrombocytopenia, bone marrow depression, and agranulocytosis have been reported in which a causal relationship to therapy with RENITEC could not be excluded.