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| __NOTOC__
| | #REDIRECT [[Ramipril#Adverse Reactions]] |
| {{Ramipril}}
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| {{CMG}}; {{AE}} {{AM}}
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| ==Adverse Reactions==
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| ====Clinical Trials Experience====
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| Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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| ====Hypertension====
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| ALTACE has been evaluated for safety in over 4000 patients with hypertension; of these, 1230 patients were studied in U.S. controlled trials, and 1107 were studied in foreign controlled trials. Almost 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in ALTACE and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ALTACE in placebo-controlled trials were: [[headache]] (5.4%), [[dizziness]] (2.2%), and [[fatigue]] or [[asthenia]] (2.0%), but only the last one was more common in ALTACE patients than in patients given placebo. Generally the side effects were mild and transient, and there was no relation to total dosage within the range of 1.25 mg–20 mg. Discontinuation of therapy because of a side effect was required in approximately 3% of U.S. patients treated with ALTACE. The most common reasons for discontinuation were: [[cough]] (1.0%), [[dizziness]] (0.5%), and [[impotence]] (0.4%).
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| Of observed side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with ALTACE, only asthenia (fatigue) was more common on ALTACE than placebo (2% [n=13/651] vs. 1% [n=2/286], respectively).
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| In placebo-controlled trials, there was also an excess of [[upper respiratory infection]] and [[flu syndrome]] in the ALTACE group, not attributed at that time to ramipril. 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 ALTACE patients, with about 4% of patients requiring discontinuation of treatment.
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| ====Reduction in the Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes====
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| =====HOPE Study=====
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| Safety data in the Heart Outcomes Prevention Evaluation (HOPE) study were collected as reasons for discontinuation or temporary interruption of treatment. The incidence of cough was similar to that seen in the Acute Infarction Ramipril Efficacy (AIRE) trial. The rate of angioedema was the same as in previous clinical trials.
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| ====Heart Failure Post-Myocardial Infarction====
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| =====AIRE Study=====
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| Adverse reactions (except laboratory abnormalities) considered possibly/probably related to study drug that occurred in more than 1% of patients and more frequently on ALTACE are shown below. The incidences are from the AIRE study. The follow-up time was between 6 and 46 months for this study.
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| ====Other Adverse Reactions====
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| Other adverse reactions reported in controlled clinical trials (in less than 1% of ALTACE patients), or rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug is uncertain):
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| ====Body as a whole====
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| ====Cardiovascular====
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| Symptomatic [[hypotension]] (reported in 0.5% of patients in U.S. trials) [[syncope]], and [[palpitations]].
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| ====Hematologic====
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| Pancytopenia, hemolytic anemia, and thrombocytopenia.
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| Decreases in hemoglobin or hematocrit (a low value and a decrease of 5 g/dL or 5%, respectively) were rare, occurring in 0.4% of patients receiving ALTACE alone and in 1.5% of patients receiving ALTACE plus a [[diuretic]].
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| ====Renal====
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| [[Acute renal failure]]. Some hypertensive patients with no apparent pre-existing renal disease have developed minor, usually transient, increases in [[blood urea nitrogen]] and [[serum creatinine]] when taking ALTACE, particularly when ALTACE was given concomitantly with a diuretic.
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| ====Angioneurotic edema====
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| [[Angioneurotic edema]] has been reported in 0.3% of patients in U.S. clinical trials of ALTACE.
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| ====Gastrointestinal====
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| [[Hepatic failure]], [[hepatitis]], [[jaundice]], [[pancreatitis]], [[abdominal pain]] (sometimes with enzyme changes suggesting [[pancreatitis]]), [[anorexia]], [[constipation]], [[diarrhea]], dry mouth, [[dyspepsia]], [[dysphagia]], [[gastroenteritis]], increased salivation, and taste disturbance.
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| ====Dermatologic====
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| Apparent [[hypersensitivity reactions]] (manifested by [[urticaria]], [[pruritus]], or [[rash]], with or without fever), [[photosensitivity]], [[purpura]], [[onycholysis]], [[pemphigus]], [[pemphigoid]], [[erythema multiforme]], [[toxic epidermal necrolysis]], and [[Stevens-Johnson syndrome]].
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| ====Neurologic and Psychiatric====
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| [[Anxiety]], [[amnesia]], [[convulsions]], [[depression]], [[hearing loss]], [[insomnia]], [[nervousness]], [[neuralgia]], [[neuropathy]], [[paresthesia]], [[somnolence]], [[tinnitus]], [[tremor]], [[vertigo]], and vision disturbances.
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| ====Miscellaneous====
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| As with other ACE inhibitors, a symptom complex has been reported which may include a positive [[ANA]], an elevated erythrocyte sedimentation rate, [[arthralgia]]/[[arthritis]], [[myalgia]], [[fever]], [[vasculitis]], [[eosinophilia]], [[photosensitivity]], rash and other dermatologic manifestations. Additionally, as with other ACE inhibitors, [[eosinophilic pneumonitis]] has been reported.
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| ====Other====
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| [[Arthralgia]], [[arthritis]], [[dyspnea]], [[edema]], [[epistaxis, [[impotence]], increased sweating, [[malaise]], [[myalgia]], and weight gain.
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| ===Post-Marketing Experience===
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| In addition to adverse reactions reported from clinical trials, there have been rare reports of [[hypoglycemia]] reported during ALTACE therapy when given to patients concomitantly taking oral hypoglycemic agents or [[insulin]]. The causal relationship is unknown.
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| ===Clinical Laboratory Test Findings===
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| ====Creatinine and Blood Urea Nitrogen====
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| Increases in creatinine levels occurred in 1.2% of patients receiving ALTACE alone, and in 1.5% of patients receiving ALTACE and a diuretic. Increases in [[blood urea nitrogen]] levels occurred in 0.5% of patients receiving ALTACE alone and in 3% of patients receiving ALTACE with a diuretic. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with [[renal insufficiency]] or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with [[renal artery stenosis]]. As ramipril decreases aldosterone secretion, elevation of serum potassium can occur. Use potassium supplements and potassium sparing diuretics with caution, and monitor the patient's [[serum potassium]] frequently.
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| ====Hemoglobin and Hematocrit====
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| Decreases in hemoglobin or hematocrit (a low value and a decrease of 5 g/dL or 5%, respectively) were rare, occurring in 0.4% of patients receiving ALTACE alone and in 1.5% of patients receiving ALTACE plus a [[diuretic]]. No US patients discontinued treatment because of decreases in hemoglobin or hematocrit.
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| ====Other (causal relationships unknown)====
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| Clinically important changes in standard laboratory tests were rarely associated with ALTACE administration. Elevations of liver enzymes, [[serum bilirubin]], [[uric acid]], and blood glucose have been reported, as have cases of [[hyponatremia]] and scattered incidents of [[leucopenia]], [[eosinophilia]], and [[proteinuria]]. In US trials, less than 0.2% of patients discontinued treatment for laboratory abnormalities; all of these were cases of proteinuria or abnormal liver-function tests.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046 | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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