Section 03 · Monograph

Droxidopa

Reviewed Nov 2026FDA label

NortheraNorepinephrine precursor

Black Box Warning

WARNING: SUPINE HYPERTENSION — NORTHERA can cause supine hypertension
Monitor supine blood pressure prior to and during treatment, and more frequently when increasing doses
Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this elevated position
If supine hypertension cannot be adequately managed by elevation of the head of the bed, reduce or discontinue NORTHERA

Treatment of orthostatic dizziness, lightheadedness, or the 'feeling that you are about to black out' in adults with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathyFDA-labeled
Continued effectiveness beyond 2 weeks of treatment has not been established; the physician should periodically reassess the need for continued treatmentFDA-labeled

Synthetic amino acid precursor of norepinephrine
Directly metabolized to norepinephrine by dopa-decarboxylase (the same enzyme that converts levodopa to dopamine), including in tissues lacking dopamine-beta-hydroxylase
Exogenously formed norepinephrine increases peripheral vascular resistance via arterial and venous vasoconstriction, raising blood pressure in patients with neurogenic orthostatic hypotension

Starting dose: 100 mg three times daily (morning, midday, and late afternoon, at least 3 hours before bedtime)
Titrate by 100 mg three times daily approximately every 24–48 hours based on response/tolerability, up to a maximum of 600 mg three times daily (1,800 mg/day)
Take consistently either always with food or always without food
Schedule final daily dose at least 3 hours prior to bedtime to reduce supine hypertension risk while asleep

No dosage adjustment needed for mild-to-moderate renal impairment (GFR >30 mL/min); limited data in severe renal impairment — use caution

Norepinephrine-potentiating agents (e.g., norepinephrine reuptake inhibitors, triptans, ephedrine, midodrine) — may increase risk/severity of hypertension
Non-selective MAO inhibitors and linezolid — should be avoided due to increased risk of pressor effects; selective MAO-B inhibitors (e.g., selegiline, rasagiline) were permitted in clinical trials
Dopa-decarboxylase inhibitors (e.g., carbidopa) — may alter droxidopa conversion to norepinephrine
Drugs that increase blood pressure (e.g., NSAIDs affecting fluid retention, fludrocortisone) — additive supine hypertension risk

Measure supine and standing blood pressure prior to initiation, and reassess after each dose titration
Advise head-of-bed elevation and re-measure supine blood pressure in the elevated position
Reduce dose or discontinue if supine hypertension is not adequately controlled with head-of-bed elevation
Observe for neuroleptic malignant syndrome (NMS)-like signs and symptoms, particularly with dosage changes or when concomitant levodopa/neuroleptic therapy is reduced or withdrawn
Periodically reassess ongoing need for therapy, as benefit beyond 2 weeks has not been established

Pregnancy: no adequate human data; animal reproduction studies did not show major structural birth defects, though some reproductive/developmental findings were noted in offspring at high doses
Lactation: advise women not to breastfeed during treatment with NORTHERA due to the potential for serious adverse reactions in the breastfed infant