Drugs › alpha-Adrenergic agonist
Brand name · Loratadine and pseudoephedrine sulfate
Claritin-D: adverse event reports filed with FDA
732 reports list it as a suspect or interacting product, 2004–2026. Class: alpha-Adrenergic agonist. Also reported as Claritin-D Nos.
- 732
- reports as suspect product
- 0% of all reports · about 33 a year
- 16
- reports, 12 months to June 2026
- 27 in the 12 months before
- 22.5%
- marked serious by the reporter
- 50.8% across the class
- 0.3%
- record death among outcomes, as reported
- 2 reports · not verified by FDA
732 adverse event reports received by FDA list the brand name Claritin-D (loratadine and pseudoephedrine sulfate) as a suspect or interacting product, from February 2004 to June 2026. A further 2,561 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, 16 reports listed it, down 41% from 27 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 33 reports a year and 0% of the 20,646,523 reports in the database, and 3.1% of the reports for the alpha-Adrenergic agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (20.8%), insomnia (9.8%) and drug effect decreased (4.9%). A report can list several reactions, so shares add to more than 100%; 177 different terms appear across these reports. Drug ineffective is recorded in 20.8% of these reports, a larger share than in the median alpha-Adrenergic agonist drug (11.8%).
22.5% of the reports are marked serious by the reporter (50.8% across the class); 0.3% record death among the outcomes and 4.6% record hospitalisation, as reported. 88.9% of the reports came from consumers, and the largest patient age group is 18 to 44 (20.9%). 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 Claritin-D reports recording the termmedian drug in alpha-adrenergic agonist
- Drug ineffectivethe medicine did not work as expected20.8%152
- Insomniadifficulty sleeping9.8%72
- Drug effect decreasedthe medicine had less effect4.9%36
- Somnolencedrowsiness4.6%34
- Dizzinesslight-headedness or unsteadiness3.8%28
- Feeling abnormalfeeling odd or not right3.4%25
- Product use in unapproved indicationused for a purpose not on the label3.3%24
- Heart rate increaseda fast heart rate reading2.9%21
- Headachehead pain2.7%20
- Drug hypersensitivityan allergic-type reaction to a medicine2.5%18
- Dyspnoeashortness of breath2.3%17
- Fatiguetiredness2.2%16
- Feeling jittery2.2%16
- Off label useused for a purpose or in a way not on the label2.2%16
- Drug effect delayed1.9%14
- Product use issuea problem in how the product was used1.9%14
- Anxietyanxiety1.8%13
- Hypersensitivityan allergic-type reaction1.8%13
- Palpitationsawareness of the heartbeat1.8%13
- Blood pressure increaseda raised blood pressure reading1.5%11
- Extra dose administered1.4%10
- Nervousnessnervousness1.4%10
- Dry mouthdry mouth1.2%9
- Nauseafeeling sick1.2%9
- Tremorshaking1.2%9
- Chest painchest pain1.1%8
- Condition aggravatedthe condition being treated got worse1.1%8
- Hallucinationseeing or hearing things that are not there1.1%8
Top 30 of 177 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 11 drugs in the alpha-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 23,291 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. 92.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypersensitivity | 130 | 17.8% |
| Nasopharyngitis | 76 | 10.4% |
| Nasal congestion | 23 | 3.1% |
| Multiple allergies | 19 | 2.6% |
| Sinus congestion | 15 | 2% |
| Seasonal allergy | 6 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 732 reports.
In context
| Measure | Claritin-D | alpha-Adrenergic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 732 | 23,291 | 20,646,523 |
| Share of that pool | — | 3.1% | 0% |
| Reports, latest 12 months | 16 | — | 1,332,454 |
| Marked serious | 22.5% | 50.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 3 | 156 | 91 |
| Hospitalisation recorded, per 1,000 reports | 46 | 199 | 213 |
| Consumer-filed share | 88.9% | 48.1% | 45.8% |
| Top term, share of reports | Drug ineffective 20.8% | median 11.8% | 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-adrenergic agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Pseudoephedrine hydrochloride | generic | 8,381 | 1,163 | 90.4% |
| Brimonidine | generic | 4,285 | 122 | 17.7% |
| Combigan | brand | 2,940 | 49 | 23.1% |
| Alphagan P | brand | 2,656 | 110 | 31.9% |
| Brimonidine tartrate | generic | 1,012 | 178 | 42.2% |
| Mirvaso | brand | 926 | 2 | 21% |
| Alavert | brand | 618 | 0 | 31.6% |
| Loratadine and pseudoephedrine sulfate | generic | 616 | 22 | 10.2% |
| Midodrine hydrochloride | generic | 595 | 51 | 70.1% |
| Pseudoephedrine hcl | generic | 530 | 0 | 94.7% |
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 Claritin-D reports
How many adverse event reports has FDA received for Claritin-D?
732 reports list Claritin-D as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 16 of them arrived in the latest 12 months. Another 2,561 list it only as a concomitant medication.
What reactions are recorded in Claritin-D reports?
drug ineffective (20.8%), insomnia (9.8%), drug effect decreased (4.9%), somnolence (4.6%) and dizziness (3.8%). 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 Claritin-D was responsible.
How serious are the reports?
22.5% are marked serious by the reporter. Among the outcomes recorded, 0.3% of reports include death and 4.6% 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 (88.9%), other health professional (3.7%) and not given (3.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Claritin-D rising?
16 reports in the 12 months to June 2026, down 41% from 27 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 Claritin-D 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 Claritin-D?
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 Claritin-D as a suspect or interacting product; reports listing it only as a concomitant medication (2,561) 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.