Fenoldopam Side Effects
Please note - some side effects for Fenoldopam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
|
For the professional
|
|
For the professional
Fenoldopam
Adult Patients: Fenoldopam mesylate causes a dose-related fall in blood pressure and increase in heart rate. 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.
| 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, General | Headache | 1 | 5 | 4 | 7 | 8 | 6 |
| Injection site reaction | 0 | 1 | 3 | 0 | 3 | 2 | |
| Cardiovascular | ST-T abnormalitites (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 | 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 |
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.
TopMore resources:
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
