Brand name · Loratadine

Alavert: adverse event reports filed with FDA

618 reports list it as a suspect or interacting product, 2004–2014. Class: alpha-Adrenergic agonist.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

618
reports as suspect product: 0% of all reports · about 28 a year; 0
reports, 12 months to June 2026: 0 in the 12 months before; 31.6%
marked serious by the reporter: 50.8% across the class; 0.3%
record death among outcomes, as reported: 2 reports · not verified by FDA

618 adverse event reports received by FDA list the brand name Alavert (loratadine) as a suspect or interacting product, from February 2004 to June 2014. A further 280 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, and none 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 28 reports a year and 0% of the 20,646,523 reports in the database, and 2.7% 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.

The MedDRA terms listed most often are drug ineffective (29.9%), drug effect decreased (8.9%) and somnolence (4.4%). A report can list several reactions, so shares add to more than 100%; 106 different terms appear across these reports. Drug ineffective is recorded in 29.9% of these reports, a larger share than in the median alpha-Adrenergic agonist drug (11.8%).

31.6% of the reports are marked serious by the reporter (50.8% across the class); 0.3% record death among the outcomes and 1.3% record hospitalisation, as reported. 71.2% of the reports came from consumers, and the largest patient age group is 18 to 44 (17.5%). 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

No report listing Alavert was received in the five years to June 2026; the latest was received in June 2014.

By year received

Reactions recorded in the reports

share of Alavert reports recording the termmedian drug in alpha-adrenergic agonist

Drug ineffectivethe medicine did not work as expected29.9%185
Drug effect decreasedthe medicine had less effect8.9%55
Somnolencedrowsiness4.4%27
Dizzinesslight-headedness or unsteadiness4%25
Insomniadifficulty sleeping3.6%22
Nauseafeeling sick3.4%21
Overdosea dose above the recommended amount3.2%20
Heart rate increaseda fast heart rate reading2.9%18
Blood pressure increaseda raised blood pressure reading2.8%17
Condition aggravatedthe condition being treated got worse2.6%16
Feeling abnormalfeeling odd or not right2.4%15
Fatiguetiredness2.3%14
Eye pruritus1.8%11
Hypersensitivityan allergic-type reaction1.8%11
Malaisegeneral feeling of being unwell1.8%11
Nasal congestiona blocked nose1.8%11
Headachehead pain1.6%10
Urticariahives1.6%10
Rhinorrhoeaa runny nose1.5%9
Epistaxisnosebleed1.3%8
Sneezing1.3%8
Glossodynia1.1%7
Diarrhoealoose or frequent stools1%6
Drug hypersensitivityan allergic-type reaction to a medicine1%6
Dry mouthdry mouth1%6
Anxietyanxiety0.8%5
Lacrimation increasedwatery eyes0.8%5
Product quality issuea problem with the product itself0.8%5
Vomitingbeing sick0.8%5
Abdominal pain upperupper stomach pain0.6%4

Top 30 of 106 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

Death0.3%2

Life-threatening0.3%2

Hospitalisation (initial or prolonged)1.3%8

Disability0%0

Congenital anomaly0%0

Other serious30.4%188

Not serious68.4%423

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

Under 20%0

2 to 113.1%19

12 to 172.1%13

18 to 4417.5%108

45 to 6415.5%96

65 to 748.4%52

75 and over6.1%38

Age not given47.2%292

Patient sex

Female64.6%399

Male30.6%189

Not given4.9%30

Who reported

Physician1.8%11

Pharmacist0.8%5

Other health professional1%6

Lawyer0%0

Consumer or non-health professional71.2%440

Not given25.2%156

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 89.3% 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	234	37.9%
Seasonal allergy	35	5.7%
Rhinorrhoea	29	4.7%
Eye pruritus	21	3.4%
Sneezing	14	2.3%
Nasal congestion	10	1.6%

The indication field is filled in by the reporter and is often blank; shares are of all 618 reports.

In context

Measure	Alavert	alpha-Adrenergic agonist	All reports
Reports as suspect product	618	23,291	20,646,523
Share of that pool	—	2.7%	0%
Reports, latest 12 months	0	—	1,332,454
Marked serious	31.6%	50.8%	57.4%
Death recorded among outcomes, per 1,000 reports	3	156	91
Hospitalisation recorded, per 1,000 reports	13	199	213
Consumer-filed share	71.2%	48.1%	45.8%
Top term, share of reports	Drug ineffective 29.9%	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%
Claritin-D	brand	732	16	22.5%
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 Alavert reports

How many adverse event reports has FDA received for Alavert?

618 reports list Alavert 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 280 list it only as a concomitant medication.

What reactions are recorded in Alavert reports?

drug ineffective (29.9%), drug effect decreased (8.9%), somnolence (4.4%), dizziness (4%) and insomnia (3.6%). 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 Alavert was responsible.

How serious are the reports?

31.6% are marked serious by the reporter. Among the outcomes recorded, 0.3% of reports include death and 1.3% 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?

consumer or non-health professional (71.2%), not given (25.2%) and physician (1.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Alavert rising?

0 reports in the 12 months to June 2026, and none 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 Alavert 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 Alavert?

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 Alavert as a suspect or interacting product; reports listing it only as a concomitant medication (280) 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.

What a report is

One submission to FDA about one patient: the products involved, the reactions coded with MedDRA terms, outcome flags, the patient's age and sex, and who reported. Most arrive through manufacturers, who must forward what they receive.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts reports where Alavert is suspect or interacting; 280 more list it only as a concomitant medication.

Class comparison

The hollow bars and grey bars use the alpha-adrenergic agonist class (11 drugs, 23,291 reports). The class comes from the pharmacologic class (EPC) on the FDA label. Class page.

Data version

openFDA FAERS release of 28 Sep 2026; reports received through 30 Jun 2026. Rebuilt daily.

Report an event

FDA MedWatch: Form FDA 3500 or 1-800-FDA-1088. How to report.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.