Reactine adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Reactine /00884302/, Reactine/00884302/, Reactine Unspecified

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 February 2007 to September 2021, FDA received 782 adverse event reports that name Reactine. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 3,191 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from other health professionals were 54.9% of the reports that name Reactine and 19.7% 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 Reactine 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.

FDA received no report that names Reactine in April to June 2026, in January to March 2026 or in April to June 2025.

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

This list is partial.

It covers 701 of the 782 reports (89.6%).

The site keeps reaction terms only for years in which the drug has 12 or more reports.

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 212 terms.

Reaction terms in the reports that name Reactine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 782 reports
Painpain, site not specified	470	60.1%
Pemphigus	436	55.8%
Systemic lupus erythematosuslupus, an autoimmune disease	436	55.8%
Alopeciahair loss	435	55.6%
Abdominal discomfortstomach discomfort	385	49.2%
Fatiguetiredness	378	48.3%
Glossodynia	342	43.7%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	321	41%
Swelling	232	29.7%
Drug ineffectivethe medicine did not work as expected	231	29.5%
Contraindicated product administered	199	25.4%
Hand deformity	198	25.3%
Hip arthroplasty	165	21.1%
Knee arthroplasty	164	21%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	160	20.5%
Wound	160	20.5%
Drug intolerancethe medicine was not tolerated	153	19.6%
Hypersensitivityan allergic-type reaction	150	19.2%
Rashskin rash	132	16.9%
Infusion related reactiona reaction during or soon after an infusion	131	16.8%
Hepatic enzyme increasedraised liver enzymes	129	16.5%
Product use issuea problem in how the product was used	121	15.5%
Arthropathy	108	13.8%
Asthma	107	13.7%
Discomfort	100	12.8%
Joint swellinga swollen joint	100	12.8%
Anti-cyclic citrullinated peptide antibody positive	99	12.7%
Condition aggravatedthe condition being treated got worse	99	12.7%
Pericarditisinflammation of the sac around the heart	90	11.5%
Synovitis	88	11.3%
Headachehead pain	85	10.9%
Rheumatoid factor positive	85	10.9%
Treatment failurethe treatment did not work	80	10.2%
Off label useused for a purpose or in a way not on the label	76	9.7%
Dyspnoeashortness of breath	64	8.2%
Constipation	62	7.9%
Hyperhidrosisexcessive sweating	55	7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	54	6.9%
Exposure during pregnancythe medicine was taken during pregnancy	53	6.8%
Erythemaskin redness	52	6.6%
Nauseafeeling sick	48	6.1%
Back pain	46	5.9%
Food allergy	46	5.9%
Rash erythematousa red rash	46	5.9%
General physical health deteriorationgeneral decline in health	44	5.6%
Bursitis	43	5.5%
Coeliac disease	43	5.5%
Immunodeficiency	43	5.5%
Temperature regulation disorder	43	5.5%
Upper respiratory tract infectiona cold or similar infection	43	5.5%

Download all 212 terms of Reactine (CSV)

The counts add to more than 782 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 Reactine, 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	Other Serious (Important Medical Events)	Not serious
2005	0	0	0	0	0	0	0	0
2006	0	0	0	0	0	0	0	0
2007	7	7	0	0	0	0	7	0
2008	2	2	0	0	0	0	2	0
2009	4	4	0	0	0	0	4	0
2010	4	4	0	0	3	0	2	0
2011	0	0	0	0	0	0	0	0
2012	2	2	0	0	1	0	2	0
2013	2	2	0	0	0	0	2	0
2014	3	3	0	0	3	0	0	0
2015	1	1	0	0	0	0	1	0
2016	21	20	0	0	1	0	19	1
2017	99	99	0	1	4	2	96	0
2018	124	122	1	1	8	1	118	2
2019	130	128	0	0	13	2	119	2
2020	172	171	0	3	26	11	156	1
2021	211	204	3	13	25	29	192	7
2022	0	0	0	0	0	0	0	0
2023	0	0	0	0	0	0	0	0
2024	0	0	0	0	0	0	0	0
2025	0	0	0	0	0	0	0	0
2026	0	0	0	0	0	0	0	0

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 Reactine, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Reactine, by the year in which FDA received them
Year	Reports
2007	7
2008	2
2009	4
2010	4
2011	1
2012	1
2013	6
2014	5
2015	6
2016	43
2017	100
2018	151
2019	150
2020	142
2021	160

Reports that name Reactine, 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 Reactine
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	6	0.8%
18 to 44	172	22%
45 to 64	139	17.8%
65 to 74	19	2.4%
75 and over	10	1.3%
Age not given	436	55.8%

Sex of the patient in the reports that name Reactine
Sex	Reports	Share
Female	619	79.2%
Male	89	11.4%
Unknown or not given	74	9.5%

Type of reporter in the reports that name Reactine
Reporter	Reports	Share
Physician	92	11.8%
Pharmacist	24	3.1%
Other health professional	429	54.9%
Lawyer	0	0%
Consumer or non-health professional	234	29.9%
Not given	3	0.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 3.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Reactine record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	163	20.8%
Nasopharyngitis	18	2.3%
Seasonal allergy	10	1.3%
Multiple allergies	8	1%
Hypersensitivity	6	0.8%
Pruritus	5	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 782 reports.

Drugs in the same reports

Other drugs that the reports of Reactine name, in any role, in order of name
Drug	Reports that name the two
Actemra	474
Arava	427
Cimzia	401
Enbrel	434
Folic acid	423
Fosamax	433
Humira	434
Orencia	469
Prednisone	428
Remicade	419

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

Rayos next in the A to Z list
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Rebif next in the A to Z list
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Rebif Rebidose next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for ReactineThe 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. Reactine: adverse event reports that FDA received. https://reportedreactions.com/drug/reactine/ 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 Reactine as a suspect or interacting product. The 3,191 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 Reactine 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 Reactine?

No. It is a count of what people reported to FDA: 782 reports from February 2007 to September 2021. 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 (54.9%), consumer or non-health professional (29.9%) and physician (11.8%). 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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