PRO-RAMIPRIL

Adverse Drug Reaction Overview As PRO-RAMIPRIL is an antihypertensive, the most common adverse reactions are effects secondary to its blood-pressure-lowering action. 1%). 1% patients treated with ramipril and a diuretic. 1%). 8% of patients treated with ramipril.

Cough caused discontinuation of therapy in approximately 1% of patients in North American controlled clinical trials. Post-Acute Myocardial Infarction Adverse reactions (AIRE Study) considered possibly/probably related to study drug that occurred in >1% of patients and more frequently on ramipril were: Hypotension, Cough increased, Dizziness/Vertigo, Nausea/Vomiting, Angina pectoris, Postural hypotension, Syncope, Heart failure, Severe/resistant heart failure, Myocardial infarct, Vomiting, Headache, Abnormal kidney function, Abnormal chest pain and Diarrhea.

8% of patients receiving placebo. The safety profile of ramipril in patients at Increased Risk of Cardiovascular Events (HOPE Study) was consistent with the post-marketing surveillance experience. 2%). Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Essential Hypertension Ramipril was evaluated for safety in > 4000 hypertensive patients. Almost 500 elderly patients participated in controlled trials.

Long-term safety was assessed in almost 700 patients treated for ≥1 year. There was no increase in the incidence of AEs in elderly patients given the same daily dose. The overall frequency of AEs was not related to duration of therapy or total daily dose.

1%). 1% patients treated with ramipril and a diuretic. 1%). 8%). In placebo-controlled trials, an excess of upper respiratory infection and flu syndrome was seen in the ramipril group. As these studies were carried out before the relationship of cough to ACE inhibitors was recognized, some of these events may represent ramipril- induced cough.

In a later 1-year study, increased cough was seen in almost 12% of ramipril patients, with about 4% of these patients requiring discontinuation of treatment. Approximately 1% of patients treated with ramipril monotherapy in North American controlled clinical trials (n=972) have required discontinuation because of cough.