Northera (droxidopa)
An approved treatment for Multiple System Atrophy.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Droxidopa wherever you encounter it, plus the key facts at a glance.
- Generic name
- Droxidopa
- Brand name
- Northera
- Development codes
- L-DOPS, L-threo-DOPS
- Drug class
- Norepinephrine precursor
- Manufacturer
- Lundbeck (Lundbeck NA Ltd.; approved for Chelsea Therapeutics, acquired by Lundbeck in 2014)
- How it's taken
- Oral capsules 3 times a day, the last at least 3 hours before bedtime
A capsule taken 3 times a day for dizziness, lightheadedness or the feeling of being about to black out on standing, in adults with neurogenic orthostatic hypotension (nOH), a blood pressure drop on standing caused by nerve damage.
- The label covers nOH caused by multiple system atrophy, Parkinson's disease, pure autonomic failure, dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy[1].
- The FDA approved Northera in February 2014 under accelerated approval[3], and its label says effectiveness beyond 2 weeks of treatment has not been established.
- Northera carries a boxed warning for high blood pressure while lying down (supine hypertension).
- Generic droxidopa has been sold since 2021[11].
We'll email you when Northera's FDA label changes, when the FDA acts on it, and when new trials for Multiple System Atrophy open. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
We never share your email. Unsubscribe anytime. Privacy policy · Check any health site
Where Droxidopa fits
Northera (droxidopa) and its generics are FDA approved to ease dizziness and lightheadedness on standing in adults with neurogenic orthostatic hypotension caused by multiple system atrophy, Parkinson's disease, pure autonomic failure, dopamine beta-hydroxylase deficiency or non-diabetic autonomic neuropathy[1].
- Care for orthostatic hypotension usually starts without medicine, and Cleveland Clinic lists treating the underlying cause, sitting up in bed, elastic stockings or a belly binder, and more fluid and salt[13].
- Midodrine is the other medicine FDA approved for symptomatic orthostatic hypotension, a broader use not limited to the neurogenic form.
- The midodrine label reserves it for people whose lives are considerably impaired despite standard care, because it can sharply raise blood pressure while lying down[12].
- Northera's label trials compared it with placebo, and neither label reports a trial comparing Northera with midodrine[1][12].
- Northera's label says its effectiveness beyond 2 weeks has not been established and asks doctors to check periodically whether it is still helping[1].
- A question to bring to a neurologist or autonomic specialist is how non-drug measures, blood pressure checks lying down and standing, and a 3-times-a-day schedule ending at least 3 hours before bed would fit daily life with MSA.
How Droxidopa works
In nOH, damaged nerves fail to release enough norepinephrine when a person stands, which is the signal that tightens blood vessels and holds blood pressure up. Without that signal, blood pools in the legs and belly and less reaches the brain, causing dizziness or fainting. Droxidopa is a synthetic amino acid that an enzyme called dopa decarboxylase, found throughout the body, converts directly into norepinephrine[1].
The label says droxidopa is believed to work through that norepinephrine, which raises blood pressure by narrowing arteries and veins. The label also says the exact way it eases nOH symptoms is unknown[1]. Peak droxidopa levels in the blood go with rises in blood pressure, and droxidopa has no clinically significant effect on heart rate in people with autonomic failure. Blood levels peak about 2 hours after a dose, and the drug's half-life is about 2.5 hours, which is why it is taken several times a day[1].
Side effects and safety
- Supine hypertension. Northera can cause or worsen high blood pressure while lying down; if it is not well managed, the risk of heart and blood vessel events, particularly stroke, may rise. Blood pressure is checked lying flat and in the raised-head sleeping position.
- Fever and confusion resembling neuroleptic malignant syndrome. Postmarketing reports of fever, muscle stiffness, involuntary movements and confusion. The label calls for close watching when the Northera dose changes or levodopa is cut back suddenly or stopped, especially in people taking antipsychotic (neuroleptic) medicines.
- Heart disease, rhythm problems and heart failure. Northera may worsen existing ischemic heart disease, arrhythmias and congestive heart failure, and the label asks doctors to weigh that before starting.
- Allergic reactions. Anaphylaxis, swelling (angioedema), airway tightening, hives and rash have been reported; the 300mg capsule contains tartrazine (FD&C Yellow No. 5).
- Medicines that raise blood pressure. Norepinephrine, ephedrine, midodrine and triptans would be expected to raise the risk of supine hypertension with Northera; non-selective MAO inhibitors and linezolid should be avoided.
- Carbidopa and similar Parkinson's medicines. Dopa-decarboxylase inhibitors such as carbidopa may require Northera dose adjustments; in the trials they raised droxidopa exposure about 100% without a significant need for a different dose.
- Pregnancy and breastfeeding. No human pregnancy data; a rat study showed fewer live fetuses in the offspring generation. The label advises against breastfeeding.
- Blood pressure lying down before starting and after each dose increase
- Blood pressure in the raised-head sleeping position
- Whether Northera is still easing symptoms, checked periodically because benefit beyond 2 weeks is not established
- Fever, stiffness or confusion after a dose change or a levodopa cut
Northera carries a boxed warning for supine hypertension, high blood pressure while lying down. The label says to check blood pressure lying down before and during treatment, and more often when the dose goes up. The label also says to sleep with the head of the bed raised, and to lower or stop Northera if raising the head of the bed does not control it[1].
If supine hypertension is not well managed, Northera may raise the risk of heart and blood vessel events, particularly stroke[1]. In the 8-week Study 306, headache affected 13.2% of people on Northera against 7.4% on placebo. Dizziness affected 9.6% against 4.6%, nausea 8.8% against 4.6%, and high blood pressure 7.0% against 0.9%[1]. In the shorter Studies 301 and 302, rates were lower: headache 6.1% against 3.0%, dizziness 3.8% against 1.5%, and high blood pressure 1.5% against 0%.
The side effects that most often led people to stop were high blood pressure and nausea[1]. In the long-term open-label studies, 422 people with a mean age of 65 took Northera for about a year on average. Commonly reported events were falls (24%), urinary tract infections (15%), headache (13%), fainting (13%) and dizziness (10%); these studies had no placebo group[1].
The label also warns about a rare reaction resembling neuroleptic malignant syndrome (fever, stiff muscles, confusion), reported after a dose change or when levodopa was cut back suddenly or stopped. The label warns that Northera may worsen existing heart disease, abnormal heart rhythms or heart failure, and it lists allergic reactions including anaphylaxis[1].
The 300mg capsule contains the dye FD&C Yellow No. 5 (tartrazine), which can cause allergic-type reactions in some people, more often in people allergic to aspirin. Human pregnancy data are not available, and a rat study showed fewer live fetuses in the next generation. The label advises against breastfeeding[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Droxidopa
Northera is a capsule swallowed whole 3 times a day: on waking, at midday and in the late afternoon. The last dose is taken at least 3 hours before bedtime to lower the chance of high blood pressure during sleep[1]. The starting dose is 100mg 3 times a day. The dose rises by 100mg 3 times a day every 24 to 48 hours, depending on symptoms, up to 600mg 3 times a day (1,800mg a day)[1].
Northera can be taken with or without food, but the same way each time. A high-fat meal lowers peak levels by about 35% and delays them by about 2 hours[1]. A missed dose is skipped and the next dose taken at its usual time, without doubling. The label asks patients to rest and sleep with the upper body raised[1]. Capsules come in 100mg (light blue cap), 200mg (light yellow cap) and 300mg (light green cap), in 90-count bottles. Experience in people with severe kidney impairment (GFR below 30mL/min) is limited, and the label gives no dose for them[1].
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
A capsule taken 3 times a day for as long as it helps. The label gives no price. Lundbeck's copay program covers eligible commercially insured patients using Northera, and generic droxidopa capsules from several makers have been sold since February 2021.
Help paying for Northera
With private insurance, the drugmaker's copay card can lower what you pay for Northera. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 2 charity funds for Multiple System Atrophy, 1 was open on November 9, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Eligible commercially insured patients may pay as little as $10 a month for Northera. Eligibility criteria and a program benefit limit apply; the page gives no dollar limit. Not available to people enrolled in Medicare, Medicaid or any other government healthcare program. A state may or may not allow use of the copay card when a generic is available. The card is electronic.
For: private insurance · source - Insurance and case manager help
The NORTHERA Support Center, Monday to Friday, 8 AM to 6 PM Eastern, confirms insurance coverage, checks eligibility for the StarterRx Program, enrolls eligible patients in the copay program and supports filling and delivery through Accredo, Walgreens Specialty Pharmacy and CVS Specialty.
The official page does not say who qualifies. Ask the program. · source
Good to know: The copay benefit limit and the full terms sit in a Terms and Conditions PDF that was not read. NORTHERA.com publishes no terms for the StarterRx Program and names no free-drug program for uninsured patients. Generic droxidopa has been sold since February 2021.
Charity funds for Multiple System Atrophy
- From a charity · CurePSPQuality of Life Respite Program fundOpen
Pays for: In-home respite care hours for caregivers.
The foundation says: “The Quality of Life Respite Program is now accepting applications on a rolling basis as of August 2025.”
Every program and charity fund for Multiple System Atrophy →
Clinical trial results
The 3 placebo-controlled studies randomized 485 adults with nOH from Parkinson's disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency or non-diabetic autonomic neuropathy, 245 to Northera and 240 to placebo[1]. Study 306B (NCT01176240) enrolled 171 people with Parkinson's disease and nOH. At week 1, dizziness on an 11-point scale (OHSA Item 1) fell 0.9 points more on Northera than on placebo (P=0.028), but the effect did not last beyond week 1.
Lowest standing systolic blood pressure rose 5.6 mmHg more at week 1 (P=0.032)[1][7]. More people stopped early on Northera (28%) than on placebo (20%). Study 301 (NCT00782340) randomized only people who had responded during an open-label dose-finding phase; they had Parkinson's disease (60), pure autonomic failure (36) or multiple system atrophy (26)[1][5].
Over 7 days, the label reports no statistically significant effect on its main questionnaire (OHQ, 0.4 points, P=0.19), and dizziness fell 0.7 points more on Northera (P=0.06)[1]. Study 302 (NCT00633880, 101 people, 2-week withdrawal) and the extension Study 303 (75 people, 3 months then a 2-week withdrawal) showed no statistically significant difference on their main measures[1][6].
The label concludes that effectiveness beyond 2 weeks is uncertain[1]. The FDA-required confirmatory trial, RESTORE (NCT02586623), gave 453 people open-label droxidopa for up to 16 weeks. RESTORE then randomized 253 to keep droxidopa or switch to placebo for 12 weeks. Results posted on ClinicalTrials.gov show no significant difference in time until symptoms worsened enough to need intervention (p=0.803)[8].
Development history
Chelsea Therapeutics first submitted Northera to the FDA on September 23, 2011. The FDA sent a complete response letter on March 28, 2012, and Chelsea resubmitted on August 13, 2013[3]. The FDA approved Northera on February 18, 2014 under accelerated approval, with priority review and orphan drug status. The approval required a further trial of whether the benefit lasts[3][2].
Lundbeck completed its acquisition of Chelsea Therapeutics on June 24, 2014[9]. Lundbeck's confirmatory trial, RESTORE, reached primary completion in July 2022. Its results, posted on ClinicalTrials.gov in August 2023, showed no significant difference from placebo on the main measure[8]. The FDA's list of accelerated approvals still under way, current as of August 25, 2026, still lists Northera, and the FDA has announced no change to its status[4].
The FDA approved the first generic droxidopa capsules on February 18, 2021, and Camber Pharmaceuticals announced its launch the next day[10][11]. The current label text reads revised July 2019[1].
Explore Multiple System Atrophy trials
Common questions about Droxidopa
▸What is Droxidopa (Northera)?
A capsule taken 3 times a day for dizziness, lightheadedness or the feeling of being about to black out on standing, in adults with neurogenic orthostatic hypotension (nOH), a blood pressure drop on standing caused by nerve damage. The label covers nOH caused by multiple system atrophy, Parkinson's disease, pure autonomic failure, dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy[1]. The FDA approved Northera in February 2014 under accelerated approval[3], and its label says effectiveness beyond 2 weeks of treatment has not been established. Northera carries a boxed warning for high blood pressure while lying down (supine hypertension). Generic droxidopa has been sold since 2021[11].
▸How does Droxidopa work?
In nOH, damaged nerves fail to release enough norepinephrine when a person stands, which is the signal that tightens blood vessels and holds blood pressure up. Without that signal, blood pools in the legs and belly and less reaches the brain, causing dizziness or fainting. Droxidopa is a synthetic amino acid that an enzyme called dopa decarboxylase, found throughout the body, converts directly into norepinephrine[1]. The label says droxidopa is believed to work through that norepinephrine, which raises blood pressure by narrowing arteries and veins. The label also says the exact way it eases nOH symptoms is unknown[1]. Peak droxidopa levels in the blood go with rises in blood pressure, and droxidopa has no clinically significant effect on heart rate in people with autonomic failure. Blood levels peak about 2 hours after a dose, and the drug's half-life is about 2.5 hours, which is why it is taken several times a day[1].
▸What are the side effects of Droxidopa?
Northera carries a boxed warning for supine hypertension, high blood pressure while lying down. The label says to check blood pressure lying down before and during treatment, and more often when the dose goes up. The label also says to sleep with the head of the bed raised, and to lower or stop Northera if raising the head of the bed does not control it[1]. If supine hypertension is not well managed, Northera may raise the risk of heart and blood vessel events, particularly stroke[1]. In the 8-week Study 306, headache affected 13.2% of people on Northera against 7.4% on placebo. Dizziness affected 9.6% against 4.6%, nausea 8.8% against 4.6%, and high blood pressure 7.0% against 0.9%[1]. In the shorter Studies 301 and 302, rates were lower: headache 6.1% against 3.0%, dizziness 3.8% against 1.5%, and high blood pressure 1.5% against 0%. The side effects that most often led people to stop were high blood pressure and nausea[1]. In the long-term open-label studies, 422 people with a mean age of 65 took Northera for about a year on average. Commonly reported events were falls (24%), urinary tract infections (15%), headache (13%), fainting (13%) and dizziness (10%); these studies had no placebo group[1]. The label also warns about a rare reaction resembling neuroleptic malignant syndrome (fever, stiff muscles, confusion), reported after a dose change or when levodopa was cut back suddenly or stopped. The label warns that Northera may worsen existing heart disease, abnormal heart rhythms or heart failure, and it lists allergic reactions including anaphylaxis[1]. The 300mg capsule contains the dye FD&C Yellow No. 5 (tartrazine), which can cause allergic-type reactions in some people, more often in people allergic to aspirin. Human pregnancy data are not available, and a rat study showed fewer live fetuses in the next generation. The label advises against breastfeeding[1].
▸How is Droxidopa taken?
Northera is a capsule swallowed whole 3 times a day: on waking, at midday and in the late afternoon. The last dose is taken at least 3 hours before bedtime to lower the chance of high blood pressure during sleep[1]. The starting dose is 100mg 3 times a day. The dose rises by 100mg 3 times a day every 24 to 48 hours, depending on symptoms, up to 600mg 3 times a day (1,800mg a day)[1]. Northera can be taken with or without food, but the same way each time. A high-fat meal lowers peak levels by about 35% and delays them by about 2 hours[1]. A missed dose is skipped and the next dose taken at its usual time, without doubling. The label asks patients to rest and sleep with the upper body raised[1]. Capsules come in 100mg (light blue cap), 200mg (light yellow cap) and 300mg (light green cap), in 90-count bottles. Experience in people with severe kidney impairment (GFR below 30mL/min) is limited, and the label gives no dose for them[1].
▸Is Droxidopa FDA approved?
Yes, Droxidopa (Northera) is FDA approved (2014) for the treatment of Multiple System Atrophy.
▸Does Northera keep working after the first 2 weeks?
The label says effectiveness beyond 2 weeks of treatment has not been established[1].
Short term: Study 306B showed less dizziness on Northera at week 1 (P=0.028), and the effect did not last past week 1. Study 301 showed a smaller difference that was not statistically significant (P=0.06).
Longer studies: Studies 302 and 303 used 2-week withdrawal designs and showed no statistically significant difference on their main measures.
Confirmatory trial: RESTORE (NCT02586623) found no significant difference from placebo in time until symptoms worsened over 12 weeks (p=0.803)[8].
FDA status: the FDA still lists Northera among accelerated approvals that have not converted to traditional approval[4].
Label advice: the label asks doctors to check periodically whether Northera is still helping.
Source: Northera prescribing information, revised July 2019; ClinicalTrials.gov NCT02586623; FDA accelerated approval list, August 2026.
▸Why is the last Northera dose taken at least 3 hours before bed?
The late afternoon dose is taken at least 3 hours before bedtime to lower the chance of high blood pressure during sleep, the risk named in Northera's boxed warning[1].
Schedule: on waking, at midday and in the late afternoon.
Sleep position: the label asks patients to rest and sleep with the upper body raised, and blood pressure is checked in that position too.
If it stays high: the label says to lower or stop Northera when supine hypertension persists.
Risk: poorly managed supine hypertension may raise the risk of stroke and other heart and blood vessel events.
Source: Northera prescribing information, revised July 2019.
▸Is there a generic version of Northera?
Yes. The FDA has approved generic droxidopa capsules in 100mg, 200mg and 300mg, rated AB, meaning equivalent to Northera[10].
First approvals: February 18, 2021, when the FDA approved 8 generic applications on the same day.
On sale: Camber Pharmaceuticals announced its launch on February 19, 2021, first in the 300mg strength[11].
Copay card: Lundbeck's savings page says a state may or may not allow its Northera copay card when a generic is available[14].
Source: Drugs@FDA; Camber Pharmaceuticals, February 19, 2021; NORTHERA.com.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Lundbeck Pharmaceuticals LLC via DailyMed · 2019-07-01. NORTHERA- droxidopa capsule. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2179f02c-48d7-48eb-8007-5ae43d8d16bc
- FDA · 2014-02-18. NORTHERA approval history, NDA 203202. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203202
- FDA · 2014-02-18. NORTHERA (droxidopa) 100 mg, 200 mg, and 300 mg capsules. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203202Orig1s000ltr.pdf
- FDA · 2026-08-25. Ongoing | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals. https://www.fda.gov/drugs/accelerated-approval-program/ongoing-non-malignant-hematological-neurological-and-other-disorder-indications-accelerated
- ClinicalTrials.gov. A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa. https://clinicaltrials.gov/study/NCT00782340
- ClinicalTrials.gov. Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH). https://clinicaltrials.gov/study/NCT00633880
- ClinicalTrials.gov. A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease. https://clinicaltrials.gov/study/NCT01176240
- ClinicalTrials.gov. Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension. https://clinicaltrials.gov/study/NCT02586623
- BioSpace · 2014-06-24. H. Lundbeck A/S Completes Acquisition Of Chelsea Therapeutics, Inc.. https://www.biospace.com/h-lundbeck-a-s-completes-acquisition-of-chelsea-therapeutics-inc
- FDA · 2021-02-18. Droxidopa approval history, ANDA 211726 (Annora). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211726
- Camber Pharmaceuticals · 2021-02-19. Camber Pharma Launches Generic Northera®. https://www.camberpharma.com/camber-pharma-launches-generic-northera/
- Alembic Pharmaceuticals Limited via DailyMed · 2023-01-27. MIDODRINE HYDROCHLORIDE tablet. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=03b54024-2a26-4abe-bd8b-b66bb6781fa7
- Cleveland Clinic. Orthostatic Hypotension: Symptoms & Treatment. https://my.clevelandclinic.org/health/diseases/9385-low-blood-pressure-orthostatic-hypotension
- Lundbeck. Financial Assistance for Eligible Patients | NORTHERA® (droxidopa). https://www.northera.com/patient-support/paying-for-northera
- Lundbeck. Steps to Receive your NORTHERA Prescription | NORTHERA® (droxidopa). https://www.northera.com/patient-support/your-northera-prescription