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Northera

"The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associate"...

Northera

Northera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Northera (droxidopa) is a synthetic amino acid precursor of norepinephrine used for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic orthostatic hypotension (NOH) caused by primary autonomic failure [Parkinson's disease (PD), multiple system atrophy and pure autonomic failure], dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Common side effects include headache, dizziness, nausea, and hypertension.

The recommended starting dose of Northera is 100 mg, taken orally three times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime (to reduce the potential for hypertension during sleep). Northera may interact with other drugs that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans), or Parkinson's medications. Tell your doctor all medications and supplements you use. During pregnancy, Northera should be used only if prescribed. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using Northera.

Our Northera (droxidopa) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Northera FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions with NORTHERA are included in more detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety evaluation of NORTHERA is based on two placebo-controlled studies 1-2 weeks in duration (studies 301 and 302), one 8-week placebo-controlled study (study 306) and two long-term open label extension studies (studies 303 and 304). In the placebo-controlled studies, a total of 485 patients with Parkinson's disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy were randomized and treated, 245 with NORTHERA and 240 with placebo [see Clinical Trials].

Placebo-Controlled Experience

The most commonly observed adverse reactions (those occurring at an incidence of greater than 5% in the NORTHERA group and with at least a 3% greater incidence in the NORTHERA group than in the placebo group ) in NORTHERA-treated patients during the three placebo-controlled trials were headache, dizziness, nausea, hypertension. The most common adverse reactions leading to discontinuation from NORTHERA were hypertension or increased blood pressure and nausea.

Table 1: Most Common Adverse Reactions Occurring More Frequently in the NORTHERA Group

  Study 301 and Study 302
(1-2 Weeks Randomized Treatment)
Study 306
(8-10 Week Randomized Treatment)
Placebo
(N=132)
n (%)
NORTHERA
(N=131)
n (%)
Placebo
(N=108)
n (%)
NORTHERA
(N=114)
n (%)
Headache 4 (3.0) 8 (6.1) 8 (7.4) 15 (13.2)
Dizziness 2 (1.5) 5 (3.8) 5 (4.6) 11 (9.6)
Nausea 2 (1.5) 2 (1.5) 5 (4.6) 10 (8.8)
Hypertension 0 2 (1.5) 1 (0.9) 8 (7.0)
Note: n=number of patients. Table displays adverse reactions that were reported in greater than 5% of patients in the NORTHERA group and with at least a 3% greater incidence in the NORTHERA group than in the placebo group.

Long-Term, Open-Label Tr ials with NORTHERA

In the long-term open label extension studies, a total of 422 patients, mean age 65 years, were treated with NORTHERA for a mean total exposure of approximately one year. The commonly reported adverse events were falls (24%), urinary tract infections (15%), headache (13%), syncope (13%), and dizziness (10%).

Read the entire FDA prescribing information for Northera (Droxidopa Capsules) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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