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Phenylephrine Side Effects

The most commonly reported side effects of phenylephrine include off label use, pain, and maternal exposure during pregnancy, based on 9,968 FDA adverse event reports from 2004 to 2025. 18.2% of reports found the drug to be ineffective.

Phenylephrine side effects

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

1
Drug Ineffective18.2%1,819
2
Off Label Use15.0%1,491
3
Pain10.4%1,035
4
Maternal Exposure During Pregnancy10.1%1,006
5
Condition Aggravated9.9%989
6
Pemphigus9.8%979
7
Joint Swelling9.8%978
8
Rheumatoid Arthritis9.3%923
9
Systemic Lupus Erythematosus9.0%900
10
Pericarditis9.0%899
11
Infusion Related Reaction8.9%886
12
Wound8.8%875
13
Arthropathy8.7%866
14
Rash8.7%865
15
Pneumonia8.7%865

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

Report severity

81.5%Serious8,120 reports
40.9%Hospitalizations4,079 reports
23.9%Fatal2,379 reports

Seriousness is determined by the reporter, not by OpenClaim.

Phenylephrine drug interactions

Other drugs that appear in adverse event reports alongside phenylephrine. 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
Adalimumab18.1%1,807
2
Methotrexate18.1%1,800
3
Leflunomide18.1%1,800
4
Abatacept18.0%1,796
5
Etanercept18.0%1,792
6
Diclofenac17.9%1,784
7
Rituximab17.5%1,740
8
Pseudoephedrine17.4%1,737
9
Prednisone16.8%1,677
10
Tocilizumab16.6%1,654
11
Hydroxychloroquine-sulfate16.5%1,644
12
Acetaminophen16.4%1,633
13
Oxycodone16.4%1,630
14
Sulfasalazine16.1%1,606
15
Golimumab15.8%1,574

Taken alongside

1
Acetaminophen16.1%1,602
2
Fentanyl10.4%1,040
3
Ibuprofen9.6%958
4
Pantoprazole-sodium9.6%952
5
Epinephrine9.5%948
6
Lisinopril9.4%935
7
Lorazepam9.1%910
8
Propofol9.0%896
9
Midazolam8.1%811
10
Ergocalciferol8.0%799
11
Lidocaine7.6%760
12
Aspirin7.2%714
13
Sulfasalazine7.0%696
14
Pseudoephedrine6.7%668
15
Furosemide6.6%659

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 phenylephrine side effects

56.7% of phenylephrine adverse event reports involve female patients and 27.8% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.7%
Male27.8%
Unknown15.4%

Age group

< 25.2%
2–111.3%
12–171.9%
18–6463.8%
65+27.8%

What is phenylephrine used for

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

Abdominal Pain UpperAccidental ExposureAccidental Exposure To ProductAcute Myocardial InfarctionAcute Respiratory FailureAcute SinusitisAdjuvant TherapyAdrenergic SyndromeAdverse EventAllergic SinusitisAllergyAllergy To PlantsAnaemiaAnaesthesiaAnaesthesia Procedure

Showing 15 of 535 indications

Phenylephrine brand names and reporting trend

Phenylephrine is sold under brand names including Promethazine Vc W/ Codeine, Duo-medihaler.

Brand names

Promethazine Vc W/ Codeine33
Duo-medihaler1

Quarterly reports (20042025)

20052010201520202025

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

Taking phenylephrine with another medication?

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