Drugs › alpha-1 adrenergic agonist
Generic name
Phenylephrine: adverse event reports filed with FDA
2,030 reports list it as a suspect or interacting product, 2004–2026. Class: alpha-1 adrenergic agonist. Also reported as Phenylephrine Ophthalmic Solution.
- 2,030
- reports as suspect product
- 0% of all reports · about 91 a year
- 152
- reports, 12 months to June 2026
- 198 in the 12 months before
- 90.3%
- marked serious by the reporter
- 94% across the class
- 13.9%
- record death among outcomes, as reported
- 283 reports · not verified by FDA
2,030 adverse event reports received by FDA list phenylephrine, a generic name as a suspect or interacting product, from February 2004 to June 2026. A further 2,380 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 152 reports listed it, down 23% from 198 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 91 reports a year and 0% of the 20,646,523 reports in the database, and 42% of the reports for the alpha-1 adrenergic agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug ineffective (24.5%), hypotension (10%) and maternal exposure during pregnancy (9.7%). A report can list several reactions, so shares add to more than 100%; 636 different terms appear across these reports. Drug ineffective is recorded in 24.5% of these reports, about the same share as in the median alpha-1 adrenergic agonist drug (27.6%).
90.3% of the reports are marked serious by the reporter (94% across the class); 13.9% record death among the outcomes and 43.3% record hospitalisation, as reported. 60.3% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (29.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Phenylephrine reports recording the termmedian drug in alpha-1 adrenergic agonist
- Drug ineffectivethe medicine did not work as expected24.5%498
- Hypotensionlow blood pressure10%203
- Maternal exposure during pregnancythe mother took the medicine during pregnancy9.7%196
- Off label useused for a purpose or in a way not on the label6.2%125
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine6%122
- Exposure during pregnancythe medicine was taken during pregnancy5.7%116
- Premature babya baby born early5.4%110
- Premature delivery4.8%98
- Toxicity to various agentspoisoning or toxic effect of one or more substances4.8%98
- Bradycardiaslow heart rate4.6%93
- Drug interactionan interaction between medicines4.1%84
- Intentional overdosea deliberate overdose3.9%80
- Cardiac arrestthe heart stopped3.4%69
- Dyspnoeashortness of breath3.2%65
- Hypertensionhigh blood pressure3.1%63
- Condition aggravatedthe condition being treated got worse3.1%62
- Product use in unapproved indicationused for a purpose not on the label2.9%59
- Therapy non-responderthe treatment did not work2.9%58
- Live birth2.8%56
- Maternal exposure during delivery2.7%55
- Seizurea fit or convulsion2.6%53
- Normal newborn2.5%51
- Acute kidney injurysudden loss of kidney function2.5%50
- Toxic anterior segment syndrome2.4%49
- Drug hypersensitivityan allergic-type reaction to a medicine2.3%47
- Electrocardiogram QT prolongeda QT prolongation on the ECG2.3%47
- Nauseafeeling sick2.3%47
- Metabolic acidosistoo much acid in the body fluids2.2%45
- Anxietyanxiety2.2%44
- Overdosea dose above the recommended amount2.2%44
Top 30 of 636 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the alpha-1 adrenergic agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 4,830 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 60.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypotension | 250 | 12.3% |
| Shock | 59 | 2.9% |
| Septic shock | 50 | 2.5% |
| Blood pressure management | 46 | 2.3% |
| Foetal exposure during pregnancy | 39 | 1.9% |
| Toxicity to various agents | 30 | 1.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,030 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Phenylephrine reports |
|---|---|---|
| Norepinephrine | 518 | 25.5% |
| Epinephrine | 466 | 23% |
| Vasopressin | 446 | 22% |
| Fentanyl | 374 | 18.4% |
| Propofol | 262 | 12.9% |
| Bupivacaine | 257 | 12.7% |
| Morphine | 213 | 10.5% |
| Lidocaine | 170 | 8.4% |
| Acetaminophen | 168 | 8.3% |
| Dexamethasone | 102 | 5% |
Other products listed in reports where Phenylephrine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Phenylephrine | alpha-1 adrenergic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 2,030 | 4,830 | 20,646,523 |
| Share of that pool | — | 42% | 0% |
| Reports, latest 12 months | 152 | — | 1,332,454 |
| Marked serious | 90.3% | 94% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 139 | 382 | 91 |
| Hospitalisation recorded, per 1,000 reports | 433 | 546 | 213 |
| Consumer-filed share | 5% | 5.4% | 45.8% |
| Top term, share of reports | Drug ineffective 24.5% | median 27.6% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the alpha-1 adrenergic agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Phenylephrine hydrochloride | generic | 2,800 | 613 | 96.7% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Phenylephrine reports
How many adverse event reports has FDA received for Phenylephrine?
2,030 reports list Phenylephrine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 152 of them arrived in the latest 12 months. Another 2,380 list it only as a concomitant medication.
What reactions are recorded in Phenylephrine reports?
drug ineffective (24.5%), hypotension (10%), maternal exposure during pregnancy (9.7%), off label use (6.2%) and foetal exposure during pregnancy (6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Phenylephrine was responsible.
How serious are the reports?
90.3% are marked serious by the reporter. Among the outcomes recorded, 13.9% of reports include death and 43.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (60.3%), physician (24.3%) and pharmacist (6.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Phenylephrine rising?
152 reports in the 12 months to June 2026, down 23% from 198 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Phenylephrine was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Phenylephrine?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Phenylephrine as a suspect or interacting product; reports listing it only as a concomitant medication (2,380) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.