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| __NOTOC__
| | #REDIRECT [[Fosinopril#Adverse Reactions]] |
| {{Fosinopril}}
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| {{CMG}}; {{AE}} {{AM}}
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| ==Adverse Reactions==
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| Fosinopril has been evaluated for safety in more than 2100 individuals in [[hypertension]] and [[heart failure]] trials, including approximately 530 patients treated for a year or more. Generally adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.
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| ====Hypertension====
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| In placebo-controlled clinical trials (688 fosinopril-treated patients), the usual duration of therapy was two to three months. Discontinuations due to any clinical or laboratory adverse event were 4.1% and 1.1% in fosinopril-treated and placebo-treated patients, respectively. The most frequent reasons (0.4 to 0.9%) were [[headache]], [[elevated transaminases]], [[fatigue]], [[cough]], [[diarrhea]], and [[nausea]] and [[vomiting]].
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| During clinical trials with any fosinopril regimen, the incidence of adverse events in the elderly ≥65 years old) was similar to that seen in younger patients.
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| Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with fosinopril alone and at least as frequent on fosinopril as on placebo in placebo-controlled clinical trials are shown in the table below.
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| ====Clinical Adverse Events in Placebo-Controlled Trials (Hypertension)====
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| {|
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| | [[File:aa1.png|800px|thumb]]
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| The following events were also seen at >1% on fosinopril but occurred in the placebo group at a greater rate: [[headache]], [[diarrhea]], [[fatigue]], and [[sexual dysfunctio]]n. Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.2 to 1% of patients (except as noted) treated with fosinopril in controlled or uncontrolled clinical trials (N = 1479) and less frequent, clinically significant events include (listed by body system):
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| ====General====
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| [[Chest pain]], [[edema]], [[weakness]],excessive sweating.
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| ====Cardiovascular====
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| [[Angina]]/[[myocardial infarction]], [[cerebrovascular accident]], [[hypertensive crisis]], [[rhythm disturbances]], [[palpitations]], [[hypotension]], [[syncope]], [[flushing]], [[claudication]].
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| ====Orthostatic====
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| [[Hypotension]] occurred in 1.4% of patients treated with fosinopril monotherapy. Hypotension or [[orthostatic hypotension]] was a cause for discontinuation of therapy in 0.1% of patients.
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| ====Dermatologic====
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| [[Urticaria]], [[rash]], [[photosensitivity]], [[pruritus]].
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| ====Endocrine/Metabolic====
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| [[Gout]], [[decreased libido]].
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| ====Gastrointestinal====
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| [[Pancreatitis]], [[hepatitis]], [[dysphagia]], [[abdominal distention]], [[abdominal pain]], [[flatulence]], [[constipation]], [[heartburn]], appetite/weight change, [[dry mouth]].
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| ====Hematologic====
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| [[Lymphadenopathy]].
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| ====Immunologic====
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| [[Angioedema]].
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| ====Musculoskeletal====
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| [[Arthralgia]], musculoskeletal pain, [[myalgia]]/[[muscle cramp]].
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| ====Nervous/Psychiatric====
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| Memory disturbance, [[tremor]], [[confusion]], [[mood change]], [[paresthesia]], sleep disturbance, [[drowsiness]], [[vertigo]].
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| ====Respiratory====
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| [[Bronchospasm]], [[pharyngitis]], [[sinusitis]]/[[rhinitis]], [[laryngitis]]/[[hoarseness]], [[epistaxis]]. A symptom-complex of [[cough]], bronchospasm, and [[eosinophilia]] has been observed in two patients treated with fosinopril.
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| ====Special Senses====
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| [[Tinnitus]], vision disturbance, taste disturbance, eye irritation.
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| ====Urogenital====
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| [[Renal insufficiency]], [[urinary frequency]].
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| ====Heart Failure====
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| In placebo-controlled clinical trials (361 fosinopril-treated patients), the usual duration of therapy was 3 to 6 months. Discontinuations due to any clinical or laboratory adverse event, except for [[heart failure]], were 8% and 7.5% in fosinopril-treated and placebo-treated patients, respectively. The most frequent reason for discontinuation of fosinopril was [[angina pectoris]] (1.1%). Significant hypotension after the first dose of fosinopril occurred in 14/590 (2.4%) of patients; 5/590 (0.8%) patients discontinued due to first dose [[hypotension]].
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| Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with fosinopril and at least as common as the placebo group, in placebo-controlled trials are shown in the table below.
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| ====Clinical Adverse Events in Placebo-Controlled Trials (Heart Failure)====
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| {|
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| | [[File:aa2.png|800px|thumb]]
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| |}
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| The following events also occurred at a rate of 1% or more on fosinopril but occurred on placebo more often: [[fatigue]], [[dyspnea]], [[headache]], [[rash]], [[abdominal pain]], [[muscle cramp]], [[angina pectoris]], [[edema]], and [[insomnia]].
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| The incidence of adverse events in the elderly (≥65 years old) was similar to that seen in younger patients.
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| Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.4 to 1% of patients (except as noted) treated with fosinopril in controlled clinical trials (N = 516) and less frequent, clinically significant events include (listed by body system):
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| ====General====
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| [[Fever]], [[influenza]], weight gain, [[hyperhidrosis]], sensation of cold, fall, pain.
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| ====Cardiovascular====
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| Sudden death, [[cardiorespiratory arrest]], shock (0.2%), [[atrial rhythm disturbance]], [[cardiac rhythm disturbances]], [[non anginal chest pain]], [[edema]] lower extremity, [[hypertension]], [[syncope]], [[conduction disorder]], [[bradycardia]], [[tachycardia]].
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| ====Dermatologic====
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| [[Pruritus]].
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| ====Endocrine/Metabolic====
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| [[Gout]], [[sexual dysfunction]].
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| ====Gastrointestinal====
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| [[Hepatomegaly]], [[abdominal distention]], decreased appetite, dry mouth, [[constipation]], [[flatulence]].
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| ====Immunologic====
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| [[Angioedema]] (0.2%).
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| ====Musculoskeletal====
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| Muscle ache, swelling of an extremity, weakness of an extremity.
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| ====Nervous/Psychiatric====
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| [[Cerebral infarction]], [[TIA]], [[depression]], [[numbness]], [[paresthesia]], [[vertigo]], behavior change, [[tremor]].
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| ====Respiratory====
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| Abnormal vocalization, [[rhinitis]], sinus abnormality, [[tracheobronchitis]], abnormal breathing, pleuritic chest pain.
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| ====Special Senses====
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| Vision disturbance, taste disturbance.
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| ====Urogenital====
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| Abnormal urination, kidney pain.
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| ====Potential Adverse Effects Reported with ACE Inhibitors====
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| ====Body as a Whole====
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| [[Anaphylactoid reactions]].
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| Other medically important adverse effects reported with ACE inhibitors include: [[Cardiac arrest]]; [[eosinophilic pneumonitis]]; [[neutropenia]]/[[agranulocytosis]], [[pancytopenia]], [[anemia]] (including hemolytic and aplastic), [[thrombocytopenia]]; [[acute renal failure]]; [[hepatic failure]], [[jaundice]] (hepatocellular or cholestatic); symptomatic [[hyponatremia]]; [[bullous pemphigus]], [[exfoliative dermatitis]]; a syndrome which may include: [[arthralgia]]/ [[arthritis]], [[vasculitis]], [[serositis]], [[myalgia]], [[fever]], [[rash]] or other dermatologic manifestations, a positive [[ANA]], [[leukocytosis]], [[eosinophilia]], or an elevated [[ESR]].
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| ====Laboratory Test Abnormalities====
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| ====Serum Electrolytes====
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| [[Hyperkalemia]]; [[hyponatremia]].
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| ====BUN/Serum Creatinine====
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| Elevations, usually transient and minor, of [[BUN]] or [[serum creatinine]] have been observed. In placebo-controlled clinical trials, there were no significant differences in the number of patients experiencing increases in serum creatinine (outside the normal range or 1.33 times the pre-treatment value) between the fosinopril and placebo treatment groups. Rapid reduction of longstanding or markedly elevated blood pressure by any antihypertensive therapy can result in decreases in the [[glomerular filtration rate]], and in turn, lead to increases in BUN or serum creatinine. (See PRECAUTIONS, General.)
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| ====Hematology====
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| In controlled trials, a mean hemoglobin decrease of 0.1 g/dL was observed in fosinopril-treated patients. In individual patients decreases in hemoglobin or hematocrit were usually transient, small, and not associated with symptoms. No patient was discontinued from therapy due to the development of anemia.
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| ====Other====
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| [[Neutropenia]], [[leukopenia]] and [[eosinophilia]].
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| ====Liver Function Tests====
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| Elevations of [[transaminases]], [[LDH]], [[alkaline phosphatase]] and [[serum bilirubin]] have been reported. Fosinopril therapy was discontinued because of serum transaminase elevations in 0.7% of patients. In the majority of cases, the abnormalities were either present at baseline or were associated with other etiologic factors. In those cases which were possibly related to fosinopril therapy, the elevations were generally mild and transient and resolved after discontinuation of therapy.
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| ====Pediatric Patients====
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| The adverse experience profile for pediatric patients is similar to that seen in adult patients with hypertension. The long-term effects of fosinopril on growth and development have not been studied.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = FOSINOPRIL NA (FOSINOPRIL SODIUM) TABLET [APOTEX CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eaa753e8-9fda-af0b-9d54-bdf0d1674832 | 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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