Product name as reported
Sudafed 12 Hour: adverse event reports filed with FDA
756 reports list it as a suspect or interacting product, 2004–2025.
- 756
- reports as suspect product
- 0% of all reports · about 34 a year
- 0
- reports, 12 months to June 2026
- 2 in the 12 months before
- 41.1%
- marked serious by the reporter
- 57.4% across all reports
- 1.1%
- record death among outcomes, as reported
- 8 reports · not verified by FDA
756 adverse event reports received by FDA list the product name "Sudafed 12 Hour" as reporters wrote it as a suspect or interacting product, from January 2004 to May 2025. A further 1,243 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, 0 reports listed it, against 2 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 34 reports a year and 0% of the 20,646,523 reports in the database. 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 (8.7%), incorrect dose administered (6.7%) and insomnia (6.5%). A report can list several reactions, so shares add to more than 100%; 175 different terms appear across these reports. Drug ineffective is recorded in 8.7% of these reports, against 6.3% of all reports in the database.
41.1% of the reports are marked serious by the reporter; 1.1% record death among the outcomes and 12.7% record hospitalisation, as reported. 78.7% of the reports came from consumers, and the largest patient age group is 45 to 64 (22.1%). 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
Reactions recorded in the reports
share of Sudafed 12 Hour reports recording the termall reports in the database
- Drug ineffectivethe medicine did not work as expected8.7%66
- Incorrect dose administeredthe wrong dose was given6.7%51
- Insomniadifficulty sleeping6.5%49
- Dizzinesslight-headedness or unsteadiness5.7%43
- Off label useused for a purpose or in a way not on the label5.2%39
- Product use in unapproved indicationused for a purpose not on the label5%38
- Product use issuea problem in how the product was used5%38
- Heart rate increaseda fast heart rate reading4.4%33
- Nauseafeeling sick3.8%29
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.6%27
- Headachehead pain2.9%22
- Blood pressure increaseda raised blood pressure reading2.6%20
- Drug administration errora mistake in giving the medicine2.6%20
- Expired product administeredthe product was used past its expiry date2.4%18
- Drug exposure during pregnancythe medicine was taken during pregnancy2.2%17
- Vomitingbeing sick2.2%17
- Hypersensitivityan allergic-type reaction2.1%16
- Feeling abnormalfeeling odd or not right1.9%14
- Anxietyanxiety1.7%13
- Drug effect incomplete1.7%13
- Loss of consciousnesspassing out1.7%13
- Extra dose administered1.6%12
- Feeling jittery1.6%12
- Palpitationsawareness of the heartbeat1.5%11
- Somnolencedrowsiness1.5%11
- Abdominal pain upperupper stomach pain1.3%10
- Convulsion1.3%10
- Drug interactionan interaction between medicines1.3%10
Top 30 of 175 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 share of all reports in the database; 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 20,646,523 reports. 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. 84.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Sinus congestion | 63 | 8.3% |
| Nasopharyngitis | 53 | 7% |
| Nasal congestion | 45 | 6% |
| Sinus disorder | 39 | 5.2% |
| Multiple allergies | 19 | 2.5% |
| Rhinorrhoea | 17 | 2.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 756 reports.
In context
| Measure | Sudafed 12 Hour | All reports |
|---|---|---|
| Reports as suspect product | 756 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 0 | 1,332,454 |
| Marked serious | 41.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 11 | 91 |
| Hospitalisation recorded, per 1,000 reports | 127 | 213 |
| Consumer-filed share | 78.7% | 45.8% |
| Top term, share of reports | Drug ineffective 8.7% | 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."
Questions about Sudafed 12 Hour reports
How many adverse event reports has FDA received for Sudafed 12 Hour?
756 reports list Sudafed 12 Hour as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 1,243 list it only as a concomitant medication.
What reactions are recorded in Sudafed 12 Hour reports?
drug ineffective (8.7%), incorrect dose administered (6.7%), insomnia (6.5%), dizziness (5.7%) and off label use (5.2%). 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 Sudafed 12 Hour was responsible.
How serious are the reports?
41.1% are marked serious by the reporter. Among the outcomes recorded, 1.1% of reports include death and 12.7% 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?
consumer or non-health professional (78.7%), not given (9.3%) and other health professional (6.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sudafed 12 Hour rising?
0 reports in the 12 months to June 2026, against 2 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 Sudafed 12 Hour 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 Sudafed 12 Hour?
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 Sudafed 12 Hour as a suspect or interacting product; reports listing it only as a concomitant medication (1,243) 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.