OpenClaim

Pseudoephedrine Side Effects

The most commonly reported side effects of pseudoephedrine include pain, fatigue, and abdominal discomfort, based on 46,580 FDA adverse event reports from 2004 to 2025. 21.1% of reports found the drug to be ineffective.

Pseudoephedrine side effects

Percentages show how often each reaction appears relative to total reports for pseudoephedrine.

1
Drug Ineffective21.1%9,817
2
Pain15.9%7,389
3
Fatigue15.3%7,107
4
Abdominal Discomfort14.2%6,598
5
Systemic Lupus Erythematosus14.1%6,586
6
Rheumatoid Arthritis13.9%6,490
7
Alopecia13.8%6,445
8
Pemphigus13.7%6,389
9
Rash13.4%6,233
10
Glossodynia12.9%6,006
11
Swelling12.7%5,899
12
Wound12.3%5,724
13
Hand Deformity12.2%5,694
14
Hypersensitivity11.8%5,487
15
Arthropathy11.8%5,476

These are voluntary reports and do not establish that pseudoephedrine caused these reactions.

Report severity

56.3%Serious26,230 reports
24.2%Hospitalizations11,261 reports
13.3%Fatal6,195 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pseudoephedrine drug interactions

Other drugs that appear in adverse event reports alongside pseudoephedrine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Abatacept20.1%9,353
2
Adalimumab19.7%9,154
3
Cetirizine-hydrochloride19.2%8,958
4
Prednisone19.2%8,935
5
Methotrexate19.1%8,875
6
Etanercept18.6%8,644
7
Diclofenac18.5%8,630
8
Hydroxychloroquine-sulfate18.4%8,559
9
Infliximab18.3%8,507
10
Leflunomide18.2%8,464
11
Folic-acid18.1%8,445
12
Tocilizumab17.9%8,357
13
Alendronate-sodium17.9%8,333
14
Golimumab17.8%8,305
15
Sulfasalazine17.8%8,287

Taken alongside

1
Acetaminophen19.6%9,152
2
Ibuprofen14.1%6,548
3
Ergocalciferol12.8%5,975
4
Pantoprazole-sodium11.1%5,159
5
Loratadine10.6%4,947
6
Sulfasalazine8.6%4,022
7
Cetirizine-hydrochloride8.6%4,009
8
Albuterol8.2%3,801
9
Fluticasone7.8%3,635
10
Lisinopril7.5%3,516
11
Levothyroxine-sodium7.5%3,472
12
Aspirin7.4%3,430
13
Prednisone6.6%3,055
14
Lorazepam6.5%3,008
15
Calcium6.4%2,981

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pseudoephedrine side effects

65.7% of pseudoephedrine adverse event reports involve female patients and 23.9% involve male patients. The largest age group is adult at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female65.7%
Male23.9%
Unknown10.4%

Age group

< 21.4%
2–111.5%
12–172.2%
18–6473.6%
65+21.3%

What is pseudoephedrine used for

Conditions and purposes for which patients were taking pseudoephedrine when the adverse event was reported.

Abdominal Pain UpperAbnormal Sensation In EyeAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental OverdoseAcute SinusitisAdjuvant TherapyAdverse Drug ReactionAdverse EventAffective DisorderAllergic CoughAllergic Respiratory DiseaseAllergic Respiratory Symptom

Showing 15 of 786 indications

Pseudoephedrine brand names and reporting trend

Pseudoephedrine is sold under brand names including Triprolidine And Pseudoephedrine Hydrochlorides W/ Codeine, Desloratadine And Pseudoephedrine Sulfate 24 Hour.

Brand names

Triprolidine And Pseudoephedrine Hydrochlorides W/ Codeine2,787
Desloratadine And Pseudoephedrine Sulfate 24 Hour173

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pseudoephedrine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.