Key facts
- Active ingredient
- Droxidopa
- Form
- Capsule
- Strength
- Droxidopa 100MG · Droxidopa 200MG · Droxidopa 300MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- orthostatic hypotension
- Manufacturer
- Sun Pharm
- What the pharmacy pays
- ~$48.82 for 30 — not your price
- FDA application
- ANDA214384
- FDA boxed warning
- Yes — see the boxed warning
What is Droxidopa?
From the FDA label:Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula: Droxidopa is a white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It has a molecular weight of 213.19 and a molecular formula of C 9 H 11 NO 5 . Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate, and mannitol. The capsule shell is printed with black ink. The black inks contain ferrosoferric oxide, potassium hydroxide, and shellac. The capsule shell contains the following inactive ingredients: 100 mg–FD&C Blue No. 2, gelatin, titanium dioxide; 200 mg–ferric oxide yellow, gelatin, titanium dioxide; 300 mg–FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5 (tartrazine), gelatin, titanium dioxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3)] . spl-droxidopa-capsules-structure
How to use
Starting dose is 100 mg three times during the day (2.1) • Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily (2.1) • Take consistently with or without food (2.1) • To reduce the potential for supine hypertension, elevate the head of the bed and give the last dose at least 3 hours prior to bedtime (2.1) • Take droxidopa capsule whole (2.1) 2.1 Dosing Information The recommended starting dose of droxidopa capsules 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 supine hypertension during sleep). Administer droxidopa capsules consistently, either with food or without food. Take droxidopa capsules whole. Titrate to symptomatic response, in increments of 100 mg three times daily every 24 to 48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum total daily dose of 1,800 mg). Monitor supine blood pressure prior to initiating droxidopa capsules and after increasing the dose. Patients who miss a dose of droxidopa capsules should take their next scheduled dose.
Side effects
The following adverse reactions with droxidopa capsules are included in more detail in the Warnings and Precautions section of the label: • Supine Hypertension [see Warnings and Precautions (5.1)] • Hyperpyrexia and Confusion [see Warnings and Precautions (5.2)] • May exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure [see Warnings and Precautions (5.3)] The most common adverse reactions (>5% and ≥3% compared to placebo) are headache, dizziness, nausea, and hypertension (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 droxidopa is based on two placebo-controlled studies 1 to 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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue droxidopa capsules [see Warnings and Precautions (5.1)] . WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. 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 position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue droxidopa capsules [see Warnings and Precautions (5.1)] .
Warnings
Important safety information
Droxidopa capsules may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed (5.1) • Hyperpyrexia and confusion (5.2) • May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure (5.3) • Allergic reactions (5.4) 5.1 Supine Hypertension Droxidopa therapy may cause or exacerbate supine hypertension in patients with nOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood pressure, both in the supine position and in the recommended head-elevated sleeping position. Reduce or discontinue droxidopa if supine hypertension persists. If supine hypertension is not well-managed, droxidopa may increase the risk of cardiovascular events , particularly stroke. 5.2 Hyperpyrexia and Confusion Postmarketing cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported with droxidopa use during postmarketing surveillance. Observe patients carefully when the dosage of droxidopa is changed or when concomitant levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia, muscle rigidity, involuntary movements, altered consciousness, and mental status changes. The early diagnosis of this condition is important for the appropriate management of these patients. 5.3 Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure Droxidopa may exacerbate existing ischemic heart disease, arrhythmias, and congestive heart failure. Careful consideration should be given to this potential risk prior to initiating therapy in patients with these conditions. 5.4 Allergic Reactions Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria and rash have been reported in postmarketing experience. Some of these reactions resulted in emergency treatment. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy. This product contains FD&C Yellow No. 5 (tartrazine) which may also cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity [see Contraindications (4)].
Who should not take Droxidopa
Droxidopa capsules are contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions (5.4)] . History of hypersensitivity to the drug or its ingredients (4)
Overdose — what happens if you take too much
10.1 Symptoms There have been cases of overdose reported during postmarketing surveillance. A patient ingested 7,700 mg of droxidopa and experienced a hypertensive crisis that resolved promptly with treatment. Another patient treated with a total daily dose of 2,700 mg of droxidopa capsules experienced hypertension and an intracranial hemorrhage. 10.2 Treatment There is no known antidote for droxidopa capsules overdosage. In case of an overdose that may result in an excessively high blood pressure, discontinue droxidopa capsules and treat with appropriate symptomatic and supportive therapy. Counsel patients to remain in a standing or seated position until their blood pressure drops below an acceptable limit.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Use of DOPA decarboxylase inhibitors may require dose adjustments for droxidopa (7.2) 7.1 Drugs that Increase Blood Pressure Administering droxidopa in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension. 7.2 Parkinson's Medications Dopa-decarboxylase inhibitors may require dose adjustments for droxidopa. 7.3 Non-selective MAO Inhibitors The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the droxidopa clinical trials. However, based on mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with droxidopa.
Storing Droxidopa, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Droxidopa capsules should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].”
May treat (source: NIH RxClass)
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Droxidopa treat?
- Droxidopa (Droxidopa) may be used to treat orthostatic hypotension, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Droxidopa cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $48.82 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Droxidopa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Droxidopa. To pay less, Droxidopa is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Droxidopa?
- Droxidopa is marketed by Sun Pharm. You can see Sun Pharm's full profile, rating, and other products on pharmaranks.
- Is Droxidopa a brand-name or generic drug?
- Droxidopa is a generic medication; its active ingredient is Droxidopa. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Droxidopa available over the counter?
- No. Droxidopa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Droxidopa come in?
- Droxidopa is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Droxidopa FDA-registered?
- Droxidopa is on record with the U.S. FDA under application number ANDA214384. You can verify this on its official FDA label.
- Is Droxidopa safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Droxidopa. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Droxidopa?
- Droxidopa's side effects are taken directly from its FDA label. From the label: The following adverse reactions with droxidopa capsules are included in more detail in the Warnings and Precautions section of the label: • Supine Hypertension [see Warnings and Precautions (5.1)] • Hyperpyrexia and Confusion [see Warnings and Precautions (5.2)] • May exacerbate existing ischemic he… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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