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Adverse events that occurred with at least a 3% frequency during the first 24 hours of Natrecor (nesiritide) infusion are shown in the following table.

Adverse events that are not listed in the above table that occurred in at least 1% of patients who received any of the above Natrecor (nesiritide) doses included: Tachycardia, atrial fibrillation, AV node conduction abnormalities, catheter pain, fever, injection site reaction, confusion, paresthesia, somnolence, tremor, increased cough, hemoptysis, apnea, increased creatinine, sweating, pruritus, rash, leg cramps, amblyopia, anemia. All reported events (at least 1%) are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population.

In placebo and active-controlled clinical trials, Natrecor (nesiritide) has not been associated with an increase in atrial or ventricular tachyarrhythmias. In placebo-controlled trials, the incidence of VT in both Natrecor (nesiritide) and placebo patients was 2%. In the PRECEDENT (Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Natrecor (nesiritide) Therapy) trial, the effects of Natrecor (nesiritide) (n = 163) and dobutamine (n = 83) on the provocation or aggravation of existing ventricular arrhythmias in patients with decompensated CHF was compared using Holter monitoring. Treatment with Natrecor (nesiritide) (0.015 and 0.03 mcg/kg/min without an initial bolus) for 24 hours did not aggravate preexisting VT or the frequency of premature ventricular beats, compared to a baseline 24hour Holter tape.

Clinical Laboratory

In the PRECEDENT trial, the incidence of elevations in serum creatinine to > 0.5 mg/dL above baseline through day 14 was higher in the Natrecor (nesiritide) 0.015 mcg/kg/min group (17%) and the Natrecor (nesiritide) 0.03 mcg/kg/min group (19%) than with standard therapy (11%). In the VMAC trial, through day 30, the incidence of elevations in creatinine to > 0.5 mg/dL above baseline was 28% and 21% in the Natrecor (nesiritide) (2 mcg/kg bolus followed by 0.01 mcg/kg/min) and nitroglycerin groups, respectively.

Effect on Mortality

Data from all seven studies in which 30-day data were collected are presented in the chart below. The data depict hazard ratios and confidence intervals of mortality data for randomized and treated patients with Natrecor® (nesiritide) relative to active controls through day 30 for each of the 7 individual studies (Studies 311, 325, 326, 329 [PRECEDENT], 339 [VMAC], 341 [PROACTION], and 348 [FUSION I]).

The figure (on logarithmic scale) also contains a plot for the six studies involving hospitalized or Emergency Department patients combined (n = 1507), and for all 7 studies combined (n = 1717). The percentage is the Kaplan-Meier estimate.

30-Day Hazard Ratios

The figure below represents 180-day mortality hazard ratios for randomized and treated patients from all five individual studies where 180-day data were collected, 16 week hazard ratios for Study 348 (180-day data were not collected), and the five studies with 180-day data pooled (n = 1404).

180-Day Hazard Ratios

There were few deaths in these studies, so the confidence limits around the hazard ratios for mortality are wide. The studies are also small, so some potentially important baseline imbalances exist among the treatment groups, the effects of which cannot be ascertained.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Natrecor (nesiritide) . Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency: hypersensitivity reactions.

No trials specifically examining potential drug interactions with Natrecor (nesiritide) were conducted, although many concomitant drugs were used in clinical trials. No drug interactions were detected except for an increase in symptomatic hypotension in patients receiving oral ACE inhibitors (see PRECAUTIONS, Cardiovascular).

The co-administration of Natrecor (nesiritide) with IV vasodilators such as nitroglycerin, nitroprusside, milrinone, or IV ACE inhibitors has not been evaluated (these drugs were not co-administered with Natrecor (nesiritide) in clinical trials).

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.