What the label lists and what reports show
Droxidopa side effects
Droxidopa's FDA label: “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 Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” FAERS holds 21,452 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood pressure increased (1,885 reports).
- Generic listed
- Boxed warning
Check it at the source: the droxidopa FDA label on DailyMed (effective July 1, 2019, Lundbeck Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>5% and ≥3% compared to placebo) are headache, dizziness, nausea, and hypertension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1. Most Common Adverse Reactions Occurring More Frequently in the NORTHERA Group
| Reaction | Placebo (N=132) n (%) | NORTHERA (N=131) n (%) | Placebo (N=108) n (%) | NORTHERA (N=114) |
|---|---|---|---|---|
| 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) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions with NORTHERA 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 Lundbeck at 1-800-455-1141 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 NORTHERA 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). …
Source: FDA drug label, Lundbeck Pharmaceuticals LLC, effective July 1, 2019 (SPL set 2179f02c-48d7-48eb-8007-5ae43d8d16bc), via openFDA; the full label on DailyMed
What do FAERS reports show?
21,452 reports list droxidopa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,822 are coded as a death and 3,381 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Droxidopa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions