Levocetirizine adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Levocetirizine
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported
Also reported as: Levocetirizine /01530202/

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From August 2004 to June 2026, FDA received 1,212 adverse event reports that name Levocetirizine. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 5,564 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 101 reports in the 12 months to June 2026 and 119 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 101 (under 0.1%) name Levocetirizine. Reports from consumers or other non-health professionals were 27.4% of the reports that name Levocetirizine and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Levocetirizine is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 27 reports that name Levocetirizine.
In January to March 2026, FDA received 28.
In April to June 2025, FDA received 21.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 264 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,186 of the 1,212 reports (97.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 264 terms.

Reaction terms in the reports that name Levocetirizine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,212 reports
Drug ineffectivethe medicine did not work as expected	175	14.4%
Fatiguetiredness	129	10.6%
Pruritusitching	123	10.1%
Somnolencedrowsiness	114	9.4%
Vomitingbeing sick	114	9.4%
Nauseafeeling sick	111	9.2%
Off label useused for a purpose or in a way not on the label	108	8.9%
Dizzinesslight-headedness or unsteadiness	104	8.6%
Dyspnoeashortness of breath	102	8.4%
Diarrhoealoose or frequent stools	100	8.3%
Abdominal painstomach or belly pain	92	7.6%
Malaisegeneral feeling of being unwell	92	7.6%
Pyrexiafever	91	7.5%
Condition aggravatedthe condition being treated got worse	84	6.9%
Arthralgiajoint pain	81	6.7%
Blood pressure increaseda raised blood pressure reading	80	6.6%
Cough	77	6.4%
Headachehead pain	72	5.9%
Insomniadifficulty sleeping	71	5.9%
Decreased appetitereduced appetite	70	5.8%
Tachycardiafast heart rate	65	5.4%
Abdominal discomfortstomach discomfort	64	5.3%
Painpain, site not specified	64	5.3%
Abdominal pain upperupper stomach pain	63	5.2%
Coma	63	5.2%
Urticariahives	61	5%
Astheniaweakness or lack of energy	59	4.9%
Falla fall	59	4.9%
Drug intolerancethe medicine was not tolerated	58	4.8%
Myalgiamuscle pain	58	4.8%
Arthropathy	56	4.6%
Blindnessloss of sight	54	4.5%
Alopeciahair loss	53	4.4%
Product use issuea problem in how the product was used	53	4.4%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	53	4.4%
Vision blurredblurred vision	53	4.4%
Systemic lupus erythematosuslupus, an autoimmune disease	52	4.3%
Contraindicated product administered	51	4.2%
Generalised oedema	51	4.2%
Altered state of consciousness	50	4.1%
Ascitesfluid in the abdomen	50	4.1%
Eye pain	50	4.1%
Haematuriablood in the urine	50	4.1%
Hypotensionlow blood pressure	50	4.1%
Diplopiadouble vision	49	4%
Haematemesis	49	4%
Ocular discomfort	49	4%
Pemphigus	49	4%
Presyncope	49	4%
Syncopefainting	49	4%

Download all 264 terms of Levocetirizine (CSV)

The counts add to more than 1,212 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Levocetirizine, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	2	2	0	0	2	0	0	1	0
2005	2	2	0	1	1	0	0	0	0
2006	3	3	0	0	1	0	0	2	0
2007	6	6	0	0	5	0	0	1	0
2008	4	4	0	1	1	0	0	2	0
2009	2	2	0	0	0	0	0	2	0
2011	22	22	0	0	0	0	0	22	0
2012	7	5	0	2	4	0	0	1	2
2013	28	27	4	0	11	2	0	13	1
2014	19	17	0	3	5	1	0	11	2
2015	22	12	2	0	4	1	0	8	10
2016	33	22	0	5	11	0	0	12	11
2017	55	43	2	6	10	1	0	37	12
2018	138	83	7	9	17	8	7	73	55
2019	88	73	1	7	29	1	3	49	15
2020	137	127	2	12	48	14	2	93	10
2021	78	71	4	7	17	2	1	61	7
2022	108	97	24	6	11	6	0	86	11
2023	106	90	22	14	27	12	7	82	16
2024	148	130	43	7	30	3	5	107	18
2025	126	110	20	14	46	11	10	99	16
2026	78	73	16	2	29	4	2	63	5

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Levocetirizine, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Levocetirizine, by the year in which FDA received them
Year	Reports
2004	2
2005	1
2006	4
2007	6
2008	4
2009	2
2011	22
2012	7
2013	30
2014	22
2015	23
2016	32
2017	68
2018	157
2019	94
2020	126
2021	86
2022	134
2023	87
2024	158
2025	92
2026	55

Reports that name Levocetirizine, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Levocetirizine
Age	Reports	Share
Under 2	25	2.1%
2 to 11	47	3.9%
12 to 17	50	4.1%
18 to 44	230	19%
45 to 64	266	21.9%
65 to 74	72	5.9%
75 and over	79	6.5%
Age not given	443	36.6%

Sex of the patient in the reports that name Levocetirizine
Sex	Reports	Share
Female	655	54%
Male	282	23.3%
Unknown or not given	275	22.7%

Type of reporter in the reports that name Levocetirizine
Reporter	Reports	Share
Physician	346	28.5%
Pharmacist	55	4.5%
Other health professional	452	37.3%
Lawyer	1	0.1%
Consumer or non-health professional	332	27.4%
Not given	26	2.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 30.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Levocetirizine record
Indication as recorded (MedDRA)	Reports	Share
Hypersensitivity	52	4.3%
Rhinitis allergic	42	3.5%
Pruritus	37	3.1%
Urticaria	30	2.5%
Chronic spontaneous urticaria	27	2.2%
Seasonal allergy	21	1.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,212 reports.

Drugs in the same reports

Other drugs that the reports of Levocetirizine name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	140
Adalimumab	103
Celecoxib	155
Cetirizine	108
Esomeprazole	90
Etanercept	90
Human immunoglobulin g	94
Hydrochlorothiazide	73
Pregabalin	85
Tocilizumab	120

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Levocarnitine next in the A to Z list
Levocetirizine dihydrochloride next in the A to Z list
Levobupivacaine next in the A to Z list
Levocetirizine Hydrochloride next in the A to Z list
Levo-T next in the A to Z list
Levodopa next in the A to Z list
Levitra next in the A to Z list
Levodopa/Carbidopa next in the A to Z list
Levetiracetam next in the A to Z list
Levofloxacin next in the A to Z list
Levemir next in the A to Z list
Levofloxacin 500 Mg next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for LevocetirizineThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Levocetirizine: adverse event reports that FDA received. https://reportedreactions.com/drug/levocetirizine/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Levocetirizine as a suspect or interacting product. The 5,564 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Levocetirizine was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Levocetirizine?

No. It is a count of what people reported to FDA: 1,212 reports from August 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (37.3%), physician (28.5%) and consumer or non-health professional (27.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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