Drugs › alpha-1 adrenergic agonist
Generic name
Phenylephrine hydrochloride: adverse event reports filed with FDA
2,800 reports list it as a suspect or interacting product, 2006–2026. Class: alpha-1 adrenergic agonist. Also reported as Phenylephrine Hydrochloride Ophthalmic, Phenylephrine Hydrochloride Ophthalmic Solution, Phenylephrine Hydrochloride Injection Usp.
- 2,800
- reports as suspect product
- 0% of all reports · about 137 a year
- 613
- reports, 12 months to June 2026
- 857 in the 12 months before
- 96.7%
- marked serious by the reporter
- 94% across the class
- 55.9%
- record death among outcomes, as reported
- 1,564 reports · not verified by FDA
Between February 2006 and June 2026, 2,800 adverse event reports received by FDA list phenylephrine hydrochloride, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (734) are left out of every figure here.
In the 12 months to June 2026, 613 reports listed it, down 28% from 857 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 137 reports a year and 0% of the 20,646,523 reports in the database, and 58% 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 MedDRA terms listed most often are off label use (42%), pemphigus (34.1%) and maternal exposure during pregnancy (32.6%). A report can list several reactions, so shares add to more than 100%; 496 different terms appear across these reports. Off label use is recorded in 42% of these reports, a larger share than in the median alpha-1 adrenergic agonist drug (24.1%).
96.7% of the reports are marked serious by the reporter (94% across the class); 55.9% record death among the outcomes and 62.9% record hospitalisation, as reported. 78.2% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (44.5%). 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 hydrochloride reports recording the termmedian drug in alpha-1 adrenergic agonist
- Off label useused for a purpose or in a way not on the label42%1,177
- Pemphigus34.1%955
- Maternal exposure during pregnancythe mother took the medicine during pregnancy32.6%914
- Joint swellinga swollen joint32.5%911
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease31.5%881
- Painpain, site not specified31.4%880
- Infusion related reactiona reaction during or soon after an infusion31.1%872
- Systemic lupus erythematosuslupus, an autoimmune disease31.1%870
- Pericarditisinflammation of the sac around the heart30.9%865
- Glossodynia30.8%861
- Drug ineffectivethe medicine did not work as expected30.6%857
- Wound30.4%850
- Synovitis30%841
- Folliculitis28.7%805
- Arthropathy28.6%802
- Helicobacter infection28.6%800
- Type 2 diabetes mellitustype 2 diabetes28.6%800
- Hepatic enzyme increasedraised liver enzymes28.3%792
- Mobility decreasedreduced ability to move about28.1%786
- Condition aggravatedthe condition being treated got worse27.9%782
- Hand deformity27.9%780
- Rashskin rash27.8%779
- Hypoaesthesianumbness27.3%765
- Psoriatic arthropathy27%756
- Swellingswelling27%756
- Arthralgiajoint pain26.9%752
- Duodenal ulcer perforation26.4%740
- Drug intolerancethe medicine was not tolerated26.4%739
- General physical health deteriorationgeneral decline in health26.4%739
Top 30 of 496 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. 12.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Rheumatoid arthritis | 1,511 | 54% |
| Foetal exposure during pregnancy | 80 | 2.9% |
| Hypotension | 60 | 2.1% |
| Pain | 57 | 2% |
| Reversible ischaemic neurological deficit | 14 | 0.5% |
| Pupil dilation procedure | 12 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,800 reports.
In context
| Measure | Phenylephrine hydrochloride | alpha-1 adrenergic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 2,800 | 4,830 | 20,646,523 |
| Share of that pool | — | 58% | 0% |
| Reports, latest 12 months | 613 | — | 1,332,454 |
| Marked serious | 96.7% | 94% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 559 | 382 | 91 |
| Hospitalisation recorded, per 1,000 reports | 629 | 546 | 213 |
| Consumer-filed share | 5.7% | 5.4% | 45.8% |
| Top term, share of reports | Off label use 42% | median 24.1% | 4.1% |
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 | generic | 2,030 | 152 | 90.3% |
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 hydrochloride reports
How many adverse event reports has FDA received for Phenylephrine hydrochloride?
2,800 reports list Phenylephrine hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 613 of them arrived in the latest 12 months. Another 734 list it only as a concomitant medication.
What reactions are recorded in Phenylephrine hydrochloride reports?
off label use (42%), pemphigus (34.1%), maternal exposure during pregnancy (32.6%), joint swelling (32.5%) and rheumatoid arthritis (31.5%). 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 hydrochloride was responsible.
How serious are the reports?
96.7% are marked serious by the reporter. Among the outcomes recorded, 55.9% of reports include death and 62.9% 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 (78.2%), physician (13.2%) and consumer or non-health professional (5.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Phenylephrine hydrochloride rising?
613 reports in the 12 months to June 2026, down 28% from 857 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 hydrochloride 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 hydrochloride?
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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (734) 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.