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Pseudoephedrine side effects: what 10,953 FDA adverse event reports show

Pseudoephedrine Hcl · 976 reaction terms · 325,783 drug–reaction co-reports · data 2026-09-14
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Drug class

Not stated in label

Label matched

Pseudoephedrine Hcl (Sudogest Nasal Decongestant)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

10,953 reports · 88% serious · 3,852 with death outcome · 89% female

openFDA FAERS counts, all years, deduplication not applied

Used for

• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

FDA label, Indications and Usage

Boxed warning

None in the current 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

Reporting / coding artifact 2Lab value / disease marker 7No label text to screen 31
What the badges mean

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 936 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Swollen joint count increased1,7112,361.4
2,204.9–2,529.1ROR 2,798.4 · calibrated p 5e-23 ✓
1,037.5 EB05 996.8 · IC025 +9.6
3/3 methods agree
Lab value / disease markerserious n=1,710 · 95% cliniciannot reported in cached trials
Hepatic enzyme762,314.4
1,655.7–3,235.1ROR 2,330.6 · calibrated p 7e-21 ✓
823.0 EB05 679.1 · IC025 +6.7
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=76 · 100% cliniciannot reported in cached trials
Rheumatic fever2,3102,178.5
2,058.1–2,305.9ROR 2,760.4 · calibrated p 6e-23 ✓
1,003.5 EB05 969.6 · IC025 +9.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=2,309 · 94% cliniciannot reported in cached trials
Anti-cyclic citrullinated peptide antibody positive3,5751,962.1
1,879.8–2,048.2ROR 2,912.3 · calibrated p 3e-23 ✓
957.7 EB05 931.7 · IC025 +9.7
3/3 methods agree
Lab value / disease markerserious PRR 628.4 · 93% cliniciannot reported in cached trials
Anti-cyclic citrullinated peptide antibody3271,859.6
1,598.1–2,163.9ROR 1,916.8 · calibrated p 1e-20 ✓
888.2 EB05 810.3 · IC025 +8.4
3/3 methods agree
Lab value / disease markerserious n=327 · 94% cliniciannot reported in cached trials
Lupus vulgaris5521,672.9
1,494.1–1,873.1ROR 1,761.6 · calibrated p 3e-20 ✓
860.8 EB05 802.1 · IC025 +8.8
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=552 · 96% cliniciannot reported in cached trials
Rheumatoid factor positive2,5401,520.0
1,447.7–1,596.0ROR 1,978.6 · calibrated p 5e-21 ✓
837.2 EB05 810.2 · IC025 +9.4
3/3 methods agree
Lab value / disease markerserious n=2,538 · 93% cliniciannot reported in cached trials
Deep vein thrombosis postoperative8501,477.8
1,353.6–1,613.3ROR 1,602.0 · calibrated p 9e-20 ✓
814.1 EB05 769.2 · IC025 +9.0
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=850 · 93% cliniciannot reported in cached trials
Pemphigus5,2141,395.2
1,353.3–1,438.4ROR 2,661.6 · calibrated p 1e-22 ✓
800.4 EB05 782.3 · IC025 +9.5
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 523.9 · 92% cliniciannot reported in cached trials
Duodenal ulcer perforation3,0671,385.7
1,327.8–1,446.1ROR 1,924.1 · calibrated p 8e-21 ✓
795.6 EB05 772.2 · IC025 +9.4
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 519.6 · 93% cliniciannot reported in cached trials
C-reactive protein3241,069.5
934.4–1,224.0ROR 1,102.0 · calibrated p 1e-17 ✓
656.4 EB05 598.6 · IC025 +8.2
3/3 methods agree
Lab value / disease markerserious n=324 · 95% cliniciannot reported in cached trials
Hand deformity4,5051,011.6
980.8–1,043.4ROR 1,717.6 · calibrated p 3e-20 ✓
657.2 EB05 641.2 · IC025 +9.2
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 466.4 · 93% cliniciannot reported in cached trials
Facet joint syndrome1,068986.5
918.4–1,059.7ROR 1,093.0 · calibrated p 9e-18 ✓
640.8 EB05 609.2 · IC025 +8.9
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=1,068 · 94% cliniciannot reported in cached trials
Hypocholesterolaemia99911.8
717.9–1,158.1ROR 920.1 · calibrated p 2e-16 ✓
549.5 EB05 464.5 · IC025 +6.9
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=99 · 98% cliniciannot reported in cached trials
Helicobacter infection2,989797.9
767.8–829.1ROR 1,096.9 · calibrated p 8e-18 ✓
559.1 EB05 542.5 · IC025 +8.9
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 385.9 · 93% cliniciannot reported in cached trials
Adjustment disorder with depressed mood586788.0
716.9–866.2ROR 832.5 · calibrated p 2e-16 ✓
546.3 EB05 510.2 · IC025 +8.4
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=586 · 95% cliniciannot reported in cached trials
Retinitis475764.6
688.4–849.1ROR 799.2 · calibrated p 4e-16 ✓
532.7 EB05 493.7 · IC025 +8.3
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=475 · 96% cliniciannot reported in cached trials
X-ray abnormal494735.6
664.1–814.8ROR 770.3 · calibrated p 6e-16 ✓
518.9 EB05 481.6 · IC025 +8.3
3/3 methods agree
Lab value / disease markerserious n=494 · 97% cliniciannot reported in cached trials
Dislocation of vertebra605718.0
655.0–786.9ROR 759.9 · calibrated p 7e-16 ✓
512.0 EB05 478.6 · IC025 +8.4
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=605 · 94% cliniciannot reported in cached trials
Subcutaneous drug absorption impaired142677.0
559.4–819.4ROR 685.9 · calibrated p 3e-15 ✓
467.1 EB05 406.1 · IC025 +7.2
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=142 · 100% cliniciannot reported in cached trials
Pericarditis4,261660.2
641.0–679.9ROR 1,079.8 · calibrated p 1e-17 ✓
488.3 EB05 476.1 · IC025 +8.8
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 321.1 · 93% cliniciannot reported in cached trials
Muscle injury2,017625.9
597.4–655.9ROR 767.0 · calibrated p 5e-16 ✓
468.2 EB05 451.3 · IC025 +8.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 331.6 · 94% cliniciannot reported in cached trials
Swollen joint count60619.0
462.7–828.1ROR 622.4 · calibrated p 2e-14 ✓
405.9 EB05 326.8 · IC025 +6.2
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=60 · 92% cliniciannot reported in cached trials
Peripheral venous disease960607.8
566.6–652.1ROR 666.1 · calibrated p 3e-15 ✓
455.8 EB05 432.2 · IC025 +8.4
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=960 · 95% cliniciannot reported in cached trials
Sleep disorder due to general medical condition, hypersomnia type24604.2
381.7–956.4ROR 605.5 · calibrated p 1e-13 ✓
335.4 EB05 237.2 · IC025 +4.8
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=24 · 92% cliniciannot reported in cached trials
Synovitis4,248591.3
574.4–608.7ROR 965.2 · calibrated p 4e-17 ✓
449.6 EB05 438.4 · IC025 +8.7
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 307.0 · 93% cliniciannot reported in cached trials
Folliculitis2,296548.8
525.9–572.6ROR 694.1 · calibrated p 2e-15 ✓
423.9 EB05 409.6 · IC025 +8.5
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 325.5 · 94% cliniciannot reported in cached trials
Seronegative arthritis249547.3
475.9–629.4ROR 560.0 · calibrated p 2e-14 ✓
411.1 EB05 370.0 · IC025 +7.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=249 · 94% cliniciannot reported in cached trials
Sleep disorder due to general medical condition, insomnia type1,383525.2
496.3–555.7ROR 600.9 · calibrated p 8e-15 ✓
408.8 EB05 391.0 · IC025 +8.4
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=1,382 · 93% cliniciannot reported in cached trials
Glossodynia (burning tongue/mouth pain)4,787523.1
509.7–536.9ROR 928.4 · calibrated p 6e-17 ✓
409.2 EB05 399.5 · IC025 +8.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 386.0 · 93% cliniciannot reported in cached trials
Grip strength43436.5
313.4–607.8ROR 438.2 · calibrated p 9e-13 ✓
306.4 EB05 236.9 · IC025 +5.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=43not reported in cached trials
Wound4,630383.3
373.6–393.1ROR 663.1 · calibrated p 3e-15 ✓
318.3 EB05 310.7 · IC025 +8.2
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 293.8 · serious PRR 246.9 · 94% cliniciannot reported in cached trials
Tender joint count14377.6
212.8–670.1ROR 378.1 · calibrated p 4e-11 ✓
220.5 EB05 139.6 · IC025 +3.8
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=14not reported in cached trials
C-reactive protein abnormal1,009358.4
336.0–382.4ROR 394.7 · calibrated p 7e-13 ✓
299.7 EB05 284.5 · IC025 +7.9
3/3 methods agree
Lab value / disease markerserious n=1,009 · 95% cliniciannot reported in cached trials
Acquired porphyria11352.0
185.0–669.9ROR 352.4 · calibrated p 1e-10 ✓
196.3 EB05 117.0 · IC025 +3.4
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=11not reported in cached trials
Systemic lupus erythematosus5,337340.7
333.2–348.4ROR 663.5 · calibrated p 3e-15 ✓
288.5 EB05 282.0 · IC025 +8.1
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 249.7 · serious PRR 192.8 · 93% cliniciannot reported in cached trials
Onychomadesis566302.3
277.2–329.7ROR 318.7 · calibrated p 6e-12 ✓
258.4 EB05 241.1 · IC025 +7.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=565 · 94% cliniciannot reported in cached trials
Breast cancer stage iii868298.9
278.9–320.3ROR 324.5 · calibrated p 5e-12 ✓
256.7 EB05 242.7 · IC025 +7.7
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious n=868 · 94% cliniciannot reported in cached trials
Nail operation55295.8
222.8–392.9ROR 297.3 · calibrated p 2e-11 ✓
235.1 EB05 187.4 · IC025 +5.8
3/3 methods agree
Reporting / coding artifactserious n=55not reported in cached trials
Contraindicated product administered3,896284.3
276.5–292.4ROR 440.7 · calibrated p 2e-13 ✓
246.9 EB05 240.5 · IC025 +7.9
3/3 methods agree
Reporting / coding artifactage-adj. PRR 225.7 · serious PRR 200.1 · 93% cliniciannot reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

ConceptReportsPRR 95% CIReading
Liver injury4,75330.630.0–31.3signal
Interstitial lung disease94219.017.8–20.2signal
Hyperglycaemia / diabetes2,64714.814.3–15.3signal
Depression1,0737.36.9–7.8signal
Serious infection2,8467.16.9–7.3signal
Rhabdomyolysis / myopathy1483.53.0–4.1signal
Pancreatitis1263.02.5–3.6signal
Gi bleeding1932.01.8–2.3raised
Fall / fracture3001.51.4–1.7raised
Anaphylaxis / angioedema951.51.2–1.8raised
Severe cutaneous reaction481.20.9–1.6no difference
Suicidality1301.00.9–1.2no difference
Thrombocytopenia1020.90.7–1.1no difference
Anaemia810.50.4–0.6lower than other drugs
Venous thromboembolism540.50.4–0.6lower than other drugs
Arrhythmia / qt430.40.3–0.6lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Pseudoephedrine 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 (0 of 40 signal terms matched).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Systemic lupus erythematosus5,337340.7
333.2–348.4ROR 663.5 · calibrated p 3e-15 ✓
288.5 EB05 282.0 · IC025 +8.1
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 249.7 · serious PRR 192.8 · 93% cliniciannot reported in cached trials
Pain5,31016.7
16.3–17.0ROR 31.4 · calibrated p 2e-4 ✓
16.5 EB05 16.2 · IC025 +4.0
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 13.4 · serious PRR 16.9 · 92% cliniciannot reported in cached trials
Drug ineffective (drug did not work)5,2777.7
7.6–7.9ROR 13.9 · calibrated p 0.009 ✓
7.7 EB05 7.5 · IC025 +2.9
3/3 methods agree
Reporting / coding artifactage-adj. PRR 7.6 · serious PRR 13.6not reported in cached trials
Pemphigus5,2141,395.2
1,353.3–1,438.4ROR 2,661.6 · calibrated p 1e-22 ✓
800.4 EB05 782.3 · IC025 +9.5
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 523.9 · 92% cliniciannot reported in cached trials
Rheumatoid arthritis5,21392.5
90.6–94.4ROR 175.6 · calibrated p 1e-9 ✓
88.2 EB05 86.2 · IC025 +6.4
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 67.0 · serious PRR 70.2 · 93% cliniciannot reported in cached trials
Abdominal discomfort5,11760.4
59.2–61.7ROR 112.6 · calibrated p 5e-8 ✓
58.6 EB05 57.3 · IC025 +5.8
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 49.3 · serious PRR 85.6 · 92% cliniciannot reported in cached trials
Alopecia (hair loss)5,01150.0
49.0–51.1ROR 91.3 · calibrated p 2e-7 ✓
48.7 EB05 47.6 · IC025 +5.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 37.1 · serious PRR 67.8 · 92% cliniciannot reported in cached trials
Glossodynia (burning tongue/mouth pain)4,787523.1
509.7–536.9ROR 928.4 · calibrated p 6e-17 ✓
409.2 EB05 399.5 · IC025 +8.6
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 386.0 · 93% cliniciannot reported in cached trials
Fatigue (tiredness)4,64811.5
11.3–11.8ROR 19.3 · calibrated p 0.002 ✓
11.5 EB05 11.2 · IC025 +3.5
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 9.0 · serious PRR 14.1 · 91% cliniciannot reported in cached trials
Wound4,630383.3
373.6–393.1ROR 663.1 · calibrated p 3e-15 ✓
318.3 EB05 310.7 · IC025 +8.2
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 293.8 · serious PRR 246.9 · 94% cliniciannot reported in cached trials
Swelling4,60699.3
97.1–101.6ROR 170.7 · calibrated p 2e-9 ✓
94.4 EB05 92.1 · IC025 +6.5
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 76.9 · serious PRR 99.7 · 93% cliniciannot reported in cached trials
Rash4,56620.4
19.9–20.8ROR 34.2 · calibrated p 1e-4 ✓
20.2 EB05 19.7 · IC025 +4.3
3/3 methods agree
No label text to screen
label has no adverse-reaction text
age-adj. PRR 17.4 · serious PRR 29.2 · 92% cliniciannot reported in cached trials
Hand deformity4,5051,011.6
980.8–1,043.4ROR 1,717.6 · calibrated p 3e-20 ✓
657.2 EB05 641.2 · IC025 +9.2
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 466.4 · 93% cliniciannot reported in cached trials
Pericarditis4,261660.2
641.0–679.9ROR 1,079.8 · calibrated p 1e-17 ✓
488.3 EB05 476.1 · IC025 +8.8
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 321.1 · 93% cliniciannot reported in cached trials
Synovitis4,248591.3
574.4–608.7ROR 965.2 · calibrated p 4e-17 ✓
449.6 EB05 438.4 · IC025 +8.7
3/3 methods agree
No label text to screen
label has no adverse-reaction text
serious PRR 307.0 · 93% cliniciannot reported in cached trials

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Pseudoephedrine?

In FDA FAERS, the most frequently co-reported reaction terms for Pseudoephedrine are systemic lupus erythematosus, pain, pemphigus, rheumatoid arthritis, abdominal discomfort, alopecia. 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 Pseudoephedrine have an FDA boxed warning?

No. The FDA label retrieved for Pseudoephedrine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Pseudoephedrine 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

Page generated 2026-10-14. 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.