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Fenoldopam (Fenoldopam Mesylate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adult Patients: Fenoldopam mesylate causes a dose-related fall in blood pressure and increase in heart rate (see PRECAUTIONS; Tachycardia, and Hypotension). In controlled clinical studies of severe hypertension in patients with end-organ damage, 3% (4/137) of patients withdrew because of excessive falls in blood pressure. Increased heart rate could, in theory, lead to ischemic cardiac events or worsened heart failure, although these events have not been observed. The most common events reported as associated with fenoldopam mesylate use are headache, cutaneous dilation (flushing), nausea, and hypotension, each reported in more than 5% of patients.

Adverse reactions in controlled trials in hypertensive adult patients

Adverse events occurring more than once in any dosing group (once if potentially important or plausibly drug-related) in the fixed-dose constant-infusion studies are presented in the following Table by infusion-rate group. There was no clear dose relationship, except possibly for headache, nausea, flushing.

Table 3 ADVERSE EVENTS 1 FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP
Fenoldopam Mesylate Dosage (mcg/kg/min) (Adults)
Body System Event

Placebo

(n=7)

0.01

(n=26)

0.03-0.04

(n=31)

0.1

(n=28)

0.3-0.4

(n=29)

0.6-0.8

(n=11)

Body, GeneralHeadache154786
Injection site reaction013032
CardiovascularST-T abnormalitites (primarily T-wave inversion)024010
Flushing000013
Hypotension 2 000202
Postural hypotension020000
Tachycardia000002
DigestiveNausea030354
Vomiting020212
Abdominal pain/fullness020021
Constipation000002
Diarrhea000020
Metabolic and NutritionalIncreased creatinine002000
Hypokalemia022010
NervousNervousness/anxiety001002
Insomnia020000
Dizziness011220
RespiratoryNasal congestion000002
Skin and AppendagesSweating000112
UrogenitalUrinary tract infection020100
MusculoskeletalBack pain010122

1 Includes events reported by 2 or more patients receiving fenoldopam mesylate treatment across all dose groups.
2 Investigator defined; no protocol definition.

Adverse effects in overall database

The adverse event incidences listed below are based on observations of over 1,000 fenoldopam mesylate treated adult patients and not listed in the Table 3 above.

Events reported with a frequency between 0.5 to 5% in patients treated with IV fenoldopam mesylate

Cardiovascular: extrasystoles, palpitations, bradycardia, heart failure, ischemic heart disease, myocardial infarction, angina pectoris
Metabolic: elevated BUN, elevated serum glucose, elevated transaminase, elevated LDH
General Body: non-specific chest pain, pyrexia
Hematologic/Lymphatic: leukocytosis, bleeding
Respiratory: dyspnea, upper respiratory disorder
Genitourinary: oliguria
Musculoskeletal: limb cramp

Pediatric Patients: Information relating to treatment-emergent adverse events of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.

Drug label data at the top of this Page last updated: 2007-01-08

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