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Corlopam (Fenoldopam Mesylate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adult Patients: Fenoldopam 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 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 4 ADVERSE EVENTS* FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP

Body System

                                                   Fenoldopam Dosage (mcg/kg/min)(Adults)

Event

Placebo

(n = 7)

0.01

(n = 26)

0.03 to 0.04

(n = 31)

0.1

(n = 28)

0.3 to 0.4

(n = 29)

0.6 to 0.8

(n = 11)

Body, General

Headache

1

5

4

7

8

6

Injection site

reaction

0

1

3

0

3

2

Cardiovascular

ST-T

abnormalities

(primarily T-wave

inversion)

0

2

4

0

1

0

Flushing

0

0

0

0

1

3

Hypotension**

0

0

0

2

0

2

Postural

hypotension

0

2

0

0

0

0

Tachycardia**

0

0

0

0

0

2

Digestive

Nausea

0

3

0

3

5

4

Vomiting

0

2

0

2

1

2

Abdominal pain/

fullness

0

2

0

0

2

1

Constipation

0

0

0

0

0

2

Diarrhea

0

0

0

0

2

0

Metabolic and

Nutritional

Increased
creatinine**

0

0

2

0

0

Hypokalemia**

0

2

2

0

1

0

Nervous

Nervousness/ anxiety

0

0

1

0

0

2

Insomnia

0

2

0

0

0

0

Dizziness

0

1

1

2

2

0

Respiratory

Nasal congestion

0

0

0

0

0

2

Skin and

Appendages

Sweating

0

0

0

1

1

2

Urogenital

Urinary tract

infection

0

2

0

1

0

0

Musculoskeletal

Back pain

0

1

0

1

2

2

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

Adverse effects in overall data base

The adverse event incidences listed below are based on observations of over 1,000 fenoldopam treated adult patients and not listed in Table 4 above.

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

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:  In pediatric patients, the most common adverse events reported during short-term administration in controlled trials (30 minutes) were hypotension and tachycardia. However, because of the short exposure, there is limited experience with defining adverse events in children. The long-term effects of fenoldopam on growth and development have not been studied.



REPORTS OF SUSPECTED CORLOPAM SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Corlopam. The information is not vetted and should not be considered as verified clinical evidence.

Possible Corlopam side effects / adverse reactions in 57 year old male

Reported by a pharmacist from United States on 2012-05-18

Patient: 57 year old male weighing 110.5 kg (243.0 pounds)

Reactions: Fluid Overload

Suspect drug(s):
(Fluid)

Corlopam
    Dosage: intravenous drip
    Indication: Blood Pressure
    Start date: 2012-04-22
    End date: 2012-04-25



Possible Corlopam side effects / adverse reactions in 64 year old male

Reported by a pharmacist from United States on 2012-05-25

Patient: 64 year old male weighing 198.0 kg (435.6 pounds)

Reactions: Fluid Overload, NO Therapeutic Response, Hypertension

Suspect drug(s):
Corlopam



See index of all Corlopam side effect reports >>

Drug label data at the top of this Page last updated: 2012-06-06

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