Droxidopa side effects: what 21,451 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Northera
Who reports
21,451 reports · 39% serious · 2,822 with death outcome · 47% female
Used for
NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic 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.
What it is
NORTHERA capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration.
Boxed warning
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 position.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 956 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Supine hypertension | 141 | 2,953.7 2,118.1–4,118.9ROR 2,973.2 · χ² 101,652 / p <1e-300 | 661.6 EB05 574.9 · IC025 +7.4 3/3 methods agree | Labeled — boxed warning exact term | serious n=38 | not reported in cached trials |
| Blood pressure orthostatic decreased | 93 | 367.3 289.3–466.2ROR 368.9 · χ² 24,332 / p <1e-300 | 252.4 EB05 212.2 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=30 | not reported in cached trials |
| Multiple system atrophy | 43 | 135.9 98.7–186.9ROR 136.1 · χ² 4,927 / p <1e-300 | 113.3 EB05 87.6 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=43 · 91% clinician | NCT01132326: 2/350 (0.6%) on Droxidopa (serious AE) |
| Blood pressure orthostatic | 11 | 72.1 39.1–133.0ROR 72.1 · χ² 653 / p 3e-144 | 60.5 EB05 36.0 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=3 | not reported in cached trials |
| Drug dose titration not performed | 90 | 53.9 43.6–66.6ROR 54.1 · χ² 4,373 / p <1e-300 | 50.6 EB05 42.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=10 · 73% consumer | not reported in cached trials |
| Labile blood pressure | 58 | 50.1 38.5–65.2ROR 50.3 · χ² 2,608 / p <1e-300 | 47.0 EB05 37.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Drug titration error | 85 | 33.2 26.7–41.2ROR 33.3 · χ² 2,533 / p <1e-300 | 31.9 EB05 26.6 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=2 | not reported in cached trials |
| Blood pressure fluctuation | 766 | 32.1 29.9–34.5ROR 33.3 · χ² 22,339 / p <1e-300 | 31.1 EB05 29.3 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 15.1 | NCT01132326: 1/350 (0.3%) on Droxidopa (serious AE) |
| Intentional underdose | 166 | 22.8 19.5–26.5ROR 22.9 · χ² 3,355 / p <1e-300 | 22.2 EB05 19.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 · 77% consumer | not reported in cached trials |
| Orthostatic hypotension (dizziness on standing) | 361 | 20.6 18.6–22.9ROR 21.0 · χ² 6,588 / p <1e-300 | 20.2 EB05 18.5 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 17.4 | NCT02586623: 2/451 (0.4%) on Droxidopa; 1/126 (0.8%) control (serious AE) |
| Orthostatic hypertension | 11 | 18.7 10.3–33.9ROR 18.7 · χ² 164 / p 9e-38 | 17.2 EB05 9.4 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Seizure like phenomena | 31 | 18.4 12.9–26.2ROR 18.4 · χ² 483 / p 2e-107 | 17.8 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=31 | NCT02586623: 1/126 (0.8%) control (serious AE) |
| Orthostatic intolerance | 11 | 15.3 8.4–27.7ROR 15.3 · χ² 131 / p 1e-30 | 13.6 EB05 7.1 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=5 | not reported in cached trials |
| Blood pressure decreased | 1,014 | 15.2 14.3–16.1ROR 15.9 · χ² 13,235 / p <1e-300 | 14.9 EB05 14.2 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 9.1 | NCT01132326: 1/350 (0.3%) on Droxidopa (serious AE) |
| Blood pressure immeasurable | 22 | 14.2 9.3–21.6ROR 14.2 · χ² 252 / p 4e-57 | 13.4 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Dizziness postural | 129 | 13.3 11.2–15.8ROR 13.4 · χ² 1,435 / p <1e-300 | 13.1 EB05 11.2 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=31 | not reported in cached trials |
| Freezing phenomenon | 48 | 13.2 9.9–17.6ROR 13.2 · χ² 522 / p 6e-116 | 12.8 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Presyncope (near-fainting) | 316 | 12.9 11.6–14.4ROR 13.1 · χ² 3,422 / p <1e-300 | 12.7 EB05 11.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | NCT02586623: 1/451 (0.2%) on Droxidopa (serious AE) |
| Incorrect dosage administered | 63 | 12.7 9.9–16.3ROR 12.7 · χ² 658 / p 2e-145 | 12.4 EB05 9.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=6 | not reported in cached trials |
| Blood pressure increased | 1,885 | 12.2 11.6–12.7ROR 13.2 · χ² 19,204 / p <1e-300 | 12.0 EB05 11.6 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.3 | NCT01132326: 1/350 (0.3%) on Droxidopa (serious AE) |
| Dementia with lewy bodies | 12 | 11.1 6.3–19.7ROR 11.1 · χ² 100 / p 9e-24 | 9.3 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Product difficult to swallow | 10 | 9.6 5.1–17.9ROR 9.6 · χ² 68 / p 9e-17 | 7.5 EB05 4.1 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Autonomic nervous system imbalance | 22 | 7.5 4.9–11.4ROR 7.5 · χ² 117 / p 1e-27 | 6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | not reported in cached trials |
| Blood pressure abnormal | 146 | 7.3 6.2–8.5ROR 7.3 · χ² 775 / p 6e-171 | 7.1 EB05 6.2 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | NCT01132326: 1/350 (0.3%) on Droxidopa (serious AE) |
| Blood pressure systolic decreased | 33 | 7.2 5.1–10.1ROR 7.2 · χ² 168 / p 1e-38 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=12 | not reported in cached trials |
| Blood pressure diastolic increased | 32 | 6.8 4.8–9.6ROR 6.8 · χ² 151 / p 5e-35 | 6.2 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=5 | not reported in cached trials |
| Loss of consciousness | 849 | 6.5 6.1–7.0ROR 6.7 · χ² 3,951 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.9 | not reported in cached trials |
| Amyloidosis | 11 | 6.3 3.5–11.3ROR 6.3 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Hypotension (low blood pressure) | 1,260 | 6.2 5.9–6.5ROR 6.5 · χ² 5,486 / p <1e-300 | 6.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.1 | NCT02586623: 2/451 (0.4%) on Droxidopa; 1/126 (0.8%) control (serious AE) |
| Product dose omission | 390 | 5.8 5.2–6.4ROR 5.9 · χ² 1,534 / p <1e-300 | 5.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | not reported in cached trials |
| Dizziness | 2,911 | 5.7 5.6–5.9ROR 6.5 · χ² 11,608 / p <1e-300 | 5.7 EB05 5.5 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.6 | NCT02586623: 1/451 (0.2%) on Droxidopa (serious AE) |
| Dysstasia | 171 | 5.7 4.9–6.7ROR 5.8 · χ² 660 / p 6e-146 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | not reported in cached trials |
| Drug dose omission | 958 | 5.6 5.3–6.0ROR 5.8 · χ² 3,634 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | not reported in cached trials |
| Cardiac pacemaker insertion | 33 | 5.4 3.9–7.6ROR 5.4 · χ² 114 / p 6e-27 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Hypertension (high blood pressure) | 1,149 | 5.3 5.0–5.6ROR 5.6 · χ² 4,046 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.6 | NCT02586623: 1/451 (0.2%) on Droxidopa; 1/126 (0.8%) control (serious AE) |
| Blood pressure systolic increased | 101 | 5.1 4.2–6.1ROR 5.1 · χ² 324 / p 1e-72 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 1.7 | not reported in cached trials |
| Syncope (fainting) | 504 | 4.9 4.5–5.4ROR 5.0 · χ² 1,580 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | NCT02586623: 1/451 (0.2%) on Droxidopa (serious AE) |
| Staring | 12 | 4.9 2.8–8.6ROR 4.9 · χ² 33 / p 4e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=5 | not reported in cached trials |
| Akinesia | 10 | 4.7 2.5–8.8ROR 4.7 · χ² 26 / p 2e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Blood pressure inadequately controlled | 28 | 4.5 3.1–6.6ROR 4.5 · χ² 73 / p 6e-18 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Droxidopa as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (12 of 40 signal terms matched).
- NCT02586623 — Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension (N=453, PHASE4; 83 AE terms posted; arms: Open-Label Droxidopa; Double-Blind Droxidopa; Double-Blind Placebo)
- NCT01132326 — Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) (N=350, PHASE3; 112 AE terms posted; arms: Droxidopa)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dizziness | 2,911 | 5.7 5.6–5.9ROR 6.5 · χ² 11,608 / p <1e-300 | 5.7 EB05 5.5 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.6 | NCT02586623: 1/451 (0.2%) on Droxidopa (serious AE) |
| Death | 2,181 | 2.5 2.4–2.6ROR 2.6 · χ² 2,001 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.7 | not reported in cached trials |
| Blood pressure increased | 1,885 | 12.2 11.6–12.7ROR 13.2 · χ² 19,204 / p <1e-300 | 12.0 EB05 11.6 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.3 | NCT01132326: 1/350 (0.3%) on Droxidopa (serious AE) |
| Drug ineffective (drug did not work) | 1,665 | 1.2 1.2–1.3ROR 1.3 · χ² 80 / p 2e-19 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 0.8 | not reported in cached trials |
| Headache | 1,587 | 2.5 2.4–2.6ROR 2.6 · χ² 1,442 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | NCT02586623: 4/126 (3.2%) on Droxidopa; 7/126 (5.6%) control |
| Fall | 1,510 | 4.5 4.2–4.7ROR 4.7 · χ² 4,090 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | NCT02586623: 6/451 (1.3%) on Droxidopa (serious AE) |
| Hypotension (low blood pressure) | 1,260 | 6.2 5.9–6.5ROR 6.5 · χ² 5,486 / p <1e-300 | 6.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.1 | NCT02586623: 2/451 (0.4%) on Droxidopa; 1/126 (0.8%) control (serious AE) |
| Fatigue (tiredness) | 1,198 | 1.5 1.4–1.6ROR 1.5 · χ² 212 / p 2e-48 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 0.9 | NCT02586623: 3/126 (2.4%) on Droxidopa; 1/126 (0.8%) control |
| Hypertension (high blood pressure) | 1,149 | 5.3 5.0–5.6ROR 5.6 · χ² 4,046 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.6 | NCT02586623: 1/451 (0.2%) on Droxidopa; 1/126 (0.8%) control (serious AE) |
| Nausea | 1,067 | 1.3 1.2–1.4ROR 1.3 · χ² 87 / p 6e-21 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 0.8 · ♀ 71% (drug 47%) | NCT02586623: 1/126 (0.8%) on Droxidopa; 1/126 (0.8%) control |
| Blood pressure decreased | 1,014 | 15.2 14.3–16.1ROR 15.9 · χ² 13,235 / p <1e-300 | 14.9 EB05 14.2 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 9.1 | NCT01132326: 1/350 (0.3%) on Droxidopa (serious AE) |
| Drug dose omission | 958 | 5.6 5.3–6.0ROR 5.8 · χ² 3,634 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | not reported in cached trials |
| Loss of consciousness | 849 | 6.5 6.1–7.0ROR 6.7 · χ² 3,951 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.9 | not reported in cached trials |
| Malaise (feeling unwell) | 844 | 1.9 1.8–2.0ROR 1.9 · χ² 353 / p 6e-79 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.1 | not reported in cached trials |
| Blood pressure fluctuation | 766 | 32.1 29.9–34.5ROR 33.3 · χ² 22,339 / p <1e-300 | 31.1 EB05 29.3 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 15.1 | NCT01132326: 1/350 (0.3%) on Droxidopa (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Drug dose titration not performed — n=90, PRR 53.9
- Labile blood pressure — n=58, PRR 50.1
- Intentional underdose — n=166, PRR 22.8
- Seizure like phenomena — n=31, PRR 18.4 (also seen in trial arm)
- Blood pressure immeasurable — n=22, PRR 14.2
- Freezing phenomenon — n=48, PRR 13.2
- Presyncope — n=316, PRR 12.9 (also seen in trial arm)
- Dysstasia — n=171, PRR 5.7
- Cardiac pacemaker insertion — n=33, PRR 5.4
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Droxidopa?
In FDA FAERS, the most frequently co-reported reaction terms for Droxidopa are dizziness, blood pressure increased, headache, fall, hypotension, fatigue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Droxidopa have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: 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 position.
Do FAERS signals prove that Droxidopa causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2179f02c-48d7-48eb-8007-5ae43d8d16bc, effective 20190701; matched on
openfda.generic_name.exact:"DROXIDOPA") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 996 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
DROXIDOPA, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.