What the label lists and what reports show
Phenylephrine side effects
Phenylephrine's FDA label: “Most common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.” FAERS holds 3,736 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pemphigus (1,039 reports).
- Generic listed
Check it at the source: the phenylephrine FDA label on DailyMed (effective August 19, 2026, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
From the label: adverse reactions, continuedThe following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiac disorders: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia Gastrointestinal disorders: Nausea, vomiting General disorders and administrative site conditions: Chest pain, extravasation Immune system disorders: Sulfite sensitivity Nervous system disorders: Headache, nervousness, paresthesia, tremor Psychiatric disorders: Excitability Respiratory: Pulmonary edema, rales Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Vascular disorders: Hypertensive crisis Most common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective August 19, 2026 (SPL set e1a7ab4b-0afe-4463-a039-5be0323cf2f7), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,736 reports list phenylephrine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,739 are coded as a death and 2,112 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,006, against a median of 115 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Phenylephrine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions