Drug · FAERS side-effect profile with label screen
Perflutren side effects: what 5,692 FDA adverse event reports show
Drug class
Contrast Agent for Ultrasound Imaging
FDA label (Established Pharmacologic Class)
Brand names
Definity Rt
openFDA label
Who reports
5,692 reports · 33% serious · 116 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
DEFINITY RT is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. DEFINITY RT is an ult.
FDA label, Indications and Usage
What it is
DEFINITY RT (perflutren lipid microsphere) injectable suspension is, after activation, an ultrasound contrast agent for intravenous use. The perflutren lipid microspheres are composed of perfl.
FDA label, Description section
Boxed warning
SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 13Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 18
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. 80 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Flank pain | 100 | 39.8 32.7–48.4ROR 40.5 · χ² 3,703 / p <1e-300 | 39.1 EB05 33.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Back pain | 2,421 | 38.8 37.6–40.0ROR 66.7 · χ² 89,077 / p <1e-300 | 38.4 EB05 37.1 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 · 70% consumer | no trial data cached |
| Unresponsive to stimuli | 157 | 22.6 19.4–26.4ROR 23.2 · χ² 3,206 / p <1e-300 | 22.4 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 39.4 | no trial data cached |
| Neck pain | 303 | 20.1 18.0–22.4ROR 21.1 · χ² 5,450 / p <1e-300 | 19.9 EB05 18.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Product preparation error | 95 | 17.0 13.9–20.7ROR 17.2 · χ² 1,407 / p <1e-300 | 16.8 EB05 14.2 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=4 · 86% consumer | no trial data cached |
| Spinal pain | 51 | 16.1 12.3–21.2ROR 16.2 · χ² 705 / p 1e-155 | 15.9 EB05 12.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 88% consumer | no trial data cached |
| Musculoskeletal discomfort | 71 | 15.3 12.1–19.2ROR 15.4 · χ² 929 / p 3e-204 | 15.1 EB05 12.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Muscle spasms | 755 | 15.2 14.2–16.3ROR 17.4 · χ² 10,057 / p <1e-300 | 15.1 EB05 14.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Flushing | 414 | 15.0 13.7–16.5ROR 16.1 · χ² 5,397 / p <1e-300 | 14.9 EB05 13.7 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.8 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 59 | 13.8 10.7–17.8ROR 14.0 · χ² 688 / p 7e-152 | 13.6 EB05 10.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · 74% consumer | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 203 | 13.7 11.9–15.6ROR 14.1 · χ² 2,367 / p <1e-300 | 13.6 EB05 12.1 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 23.8 | no trial data cached |
| Renal pain | 38 | 13.3 9.7–18.3ROR 13.4 · χ² 419 / p 3e-93 | 12.9 EB05 9.7 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Throat tightness | 97 | 13.3 10.9–16.2ROR 13.5 · χ² 1,086 / p 2e-238 | 13.1 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.7 · 72% consumer | no trial data cached |
| Presyncope (near-fainting) | 84 | 12.8 10.4–15.9ROR 13.0 · χ² 902 / p 2e-198 | 12.7 EB05 10.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · 75% consumer | no trial data cached |
| Muscle tightness | 46 | 10.5 7.9–14.0ROR 10.6 · χ² 385 / p 5e-86 | 10.1 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 · 80% consumer | no trial data cached |
| Oxygen saturation decreased | 153 | 10.1 8.7–11.8ROR 10.4 · χ² 1,249 / p 7e-274 | 10.0 EB05 8.7 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 17.5 · 73% consumer | no trial data cached |
| Pharyngeal swelling | 25 | 9.6 6.5–14.3ROR 9.7 · χ² 185 / p 2e-42 | 8.8 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 76% consumer | no trial data cached |
| Feeling hot | 152 | 9.1 7.8–10.7ROR 9.4 · χ² 1,095 / p 2e-240 | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · 77% consumer | no trial data cached |
| Ventricular extrasystoles | 25 | 8.9 6.0–13.1ROR 8.9 · χ² 167 / p 2e-38 | 8.0 EB05 5.6 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.1 · 72% consumer | no trial data cached |
| Musculoskeletal pain | 124 | 8.7 7.3–10.3ROR 8.8 · χ² 833 / p 1e-183 | 8.5 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.5 | no trial data cached |
| Chest pain | 401 | 8.0 7.3–8.8ROR 8.5 · χ² 2,456 / p <1e-300 | 7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.5 | no trial data cached |
| Respiratory arrest | 60 | 8.0 6.2–10.2ROR 8.0 · χ² 358 / p 4e-80 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.9 · 82% consumer | no trial data cached |
| Pallor | 55 | 7.4 5.7–9.7ROR 7.5 · χ² 300 / p 2e-67 | 7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · 76% consumer | no trial data cached |
| Ventricular tachycardia | 32 | 7.1 5.0–10.1ROR 7.2 · χ² 162 / p 2e-37 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.1 | no trial data cached |
| Lip swelling | 62 | 6.9 5.4–8.8ROR 6.9 · χ² 306 / p 9e-69 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 · 75% consumer | no trial data cached |
| Urticaria (hives) | 303 | 6.7 6.0–7.5ROR 7.0 · χ² 1,478 / p <1e-300 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.6 | no trial data cached |
| Chest discomfort | 185 | 6.7 5.8–7.7ROR 6.9 · χ² 893 / p 2e-196 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 71% consumer | no trial data cached |
| Throat irritation | 77 | 6.4 5.1–7.9ROR 6.4 · χ² 342 / p 1e-76 | 6.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Product administration error | 34 | 6.3 4.5–8.8ROR 6.3 · χ² 146 / p 7e-34 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Pain in extremity | 502 | 6.3 5.8–6.8ROR 6.8 · χ² 2,248 / p <1e-300 | 6.2 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 · 72% consumer | no trial data cached |
| Supraventricular tachycardia | 16 | 6.2 3.8–10.1ROR 6.2 · χ² 64 / p 6e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.5 | no trial data cached |
| Cardio-respiratory arrest | 68 | 6.0 4.7–7.5ROR 6.0 · χ² 276 / p 3e-62 | 5.7 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Head discomfort | 28 | 5.9 4.1–8.5ROR 5.9 · χ² 108 / p 1e-25 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 89% (drug 53%) · 75% consumer | no trial data cached |
| Paraesthesia oral | 22 | 5.6 3.7–8.6ROR 5.7 · χ² 79 / p 2e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · 71% consumer | no trial data cached |
| Ventricular fibrillation | 17 | 5.6 3.5–9.1ROR 5.6 · χ² 60 / p 4e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.8 | no trial data cached |
| Heart rate increased | 150 | 5.6 4.8–6.5ROR 5.7 · χ² 562 / p 1e-124 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.2 · ♀ 73% (drug 53%) · 79% consumer | no trial data cached |
| Respiratory distress | 39 | 5.2 3.8–7.1ROR 5.2 · χ² 128 / p 5e-30 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.2 | no trial data cached |
| Sinus tachycardia | 20 | 5.2 3.4–8.1ROR 5.2 · χ² 64 / p 7e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 75% (drug 53%) | no trial data cached |
| Dyspnoea (shortness of breath) | 797 | 5.2 4.9–5.5ROR 5.9 · χ² 2,768 / p <1e-300 | 5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.5 · 73% consumer | no trial data cached |
| Heart rate decreased | 48 | 5.0 3.8–6.6ROR 5.1 · χ² 150 / p 7e-35 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 9.1 · 77% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Back pain | 2,421 | 38.8 37.6–40.0ROR 66.7 · χ² 89,077 / p <1e-300 | 38.4 EB05 37.1 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 · 70% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 797 | 5.2 4.9–5.5ROR 5.9 · χ² 2,768 / p <1e-300 | 5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.5 · 73% consumer | no trial data cached |
| Muscle spasms | 755 | 15.2 14.2–16.3ROR 17.4 · χ² 10,057 / p <1e-300 | 15.1 EB05 14.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Pain in extremity | 502 | 6.3 5.8–6.8ROR 6.8 · χ² 2,248 / p <1e-300 | 6.2 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 · 72% consumer | no trial data cached |
| Flushing | 414 | 15.0 13.7–16.5ROR 16.1 · χ² 5,397 / p <1e-300 | 14.9 EB05 13.7 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.8 | no trial data cached |
| Chest pain | 401 | 8.0 7.3–8.8ROR 8.5 · χ² 2,456 / p <1e-300 | 7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.5 | no trial data cached |
| Headache | 382 | 2.2 2.0–2.5ROR 2.3 · χ² 271 / p 3e-61 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 · 72% consumer | no trial data cached |
| Dizziness | 330 | 2.4 2.2–2.7ROR 2.5 · χ² 286 / p 2e-64 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 74% consumer | no trial data cached |
| Urticaria (hives) | 303 | 6.7 6.0–7.5ROR 7.0 · χ² 1,478 / p <1e-300 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.6 | no trial data cached |
| Neck pain | 303 | 20.1 18.0–22.4ROR 21.1 · χ² 5,450 / p <1e-300 | 19.9 EB05 18.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Arthralgia (joint pain) | 244 | 2.2 1.9–2.5ROR 2.2 · χ² 156 / p 5e-36 | 2.2 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.0 · 74% consumer | no trial data cached |
| Pruritus (itching) | 214 | 2.1 1.8–2.4ROR 2.1 · χ² 122 / p 1e-28 | 2.1 EB05 1.9 · IC025 +0.8 | Labeled — boxed warning exact term | serious PRR 4.8 | no trial data cached |
| Erythema (skin redness) | 213 | 3.8 3.4–4.4ROR 3.9 · χ² 446 / p 3e-99 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.7 · 77% consumer | no trial data cached |
| Blood pressure increased | 203 | 4.9 4.3–5.6ROR 5.0 · χ² 627 / p 1e-138 | 4.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 · 73% consumer | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 203 | 13.7 11.9–15.6ROR 14.1 · χ² 2,367 / p <1e-300 | 13.6 EB05 12.1 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 23.8 | no trial data cached |
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.
- Flank pain — n=100, PRR 39.8
- Unresponsive to stimuli — n=157, PRR 22.6
- Neck pain — n=303, PRR 20.1
- Spinal pain — n=51, PRR 16.1
- Musculoskeletal discomfort — n=71, PRR 15.3
- Muscle spasms — n=755, PRR 15.2
- Cyanosis — n=59, PRR 13.8
- Presyncope — n=84, PRR 12.8
- Muscle tightness — n=46, PRR 10.5
- Feeling hot — n=152, PRR 9.1
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 Perflutren?
In FDA FAERS, the most frequently co-reported reaction terms for Perflutren are back pain, dyspnoea, muscle spasms, pain in extremity, flushing, chest pain. 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 Perflutren have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration.
Do FAERS signals prove that Perflutren 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 7b9de6ab-a3ac-40c9-8103-139dc7a464a2, effective 20240313; matched on
openfda.generic_name.exact:"PERFLUTREN") - 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, 120 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
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.