Hydroxychloroquine sulfate adverse event reports that FDA received

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

Name type: Generic name
Class: Antimalarial
Also reported as: Hydroxychloroquine Sulfate Tablets Usp, Hydroxychloroquine Sulfate 200mg Tablets Usp, Hydroxychloroquine Sulfate Tablets

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.

Reports on file

From January 2004 to June 2026, FDA received 24,018 adverse event reports that name Hydroxychloroquine sulfate. In these reports the drug is a suspect or interacting product.

In the same period, 16,145 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1,324 reports in the 12 months to June 2026 and 1,832 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Hydroxychloroquine sulfate 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 298 reports that name Hydroxychloroquine sulfate.
In January to March 2026, FDA received 257.
In April to June 2025, FDA received 337.

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 1,186 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 23,972 of the 24,018 reports (99.8%).

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 1,186 terms.

Reaction terms in the reports that name Hydroxychloroquine sulfate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 24,018 reports
Drug ineffectivethe medicine did not work as expected	15,110	62.9%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	11,631	48.4%
Painpain, site not specified	8,543	35.6%
Drug intolerancethe medicine was not tolerated	8,262	34.4%
Contraindicated product administered	7,596	31.6%
Fatiguetiredness	7,473	31.1%
Joint swellinga swollen joint	7,003	29.2%
Abdominal discomfortstomach discomfort	6,987	29.1%
Alopeciahair loss	6,970	29%
Off label useused for a purpose or in a way not on the label	6,665	27.8%
Systemic lupus erythematosuslupus, an autoimmune disease	6,554	27.3%
Rashskin rash	6,449	26.9%
Arthropathy	6,358	26.5%
Pemphigus	6,287	26.2%
Arthralgiajoint pain	6,118	25.5%
Synovitis	6,068	25.3%
Swelling	5,789	24.1%
Glossodynia	5,785	24.1%
Hand deformity	5,410	22.5%
Treatment failurethe treatment did not work	5,201	21.7%
Condition aggravatedthe condition being treated got worse	5,169	21.5%
Hypersensitivityan allergic-type reaction	4,906	20.4%
Hepatic enzyme increasedraised liver enzymes	4,709	19.6%
Wound	4,698	19.6%
Infusion related reactiona reaction during or soon after an infusion	4,598	19.1%
Therapeutic product effect decreased	4,502	18.7%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	4,344	18.1%
Product use issuea problem in how the product was used	4,151	17.3%
Pericarditisinflammation of the sac around the heart	4,114	17.1%
Discomfort	4,020	16.7%
Anti-cyclic citrullinated peptide antibody positive	3,885	16.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	3,864	16.1%
Nauseafeeling sick	3,804	15.8%
Peripheral swellingswelling of the arms or legs	3,658	15.2%
Musculoskeletal stiffnessstiffness in muscles or joints	3,466	14.4%
Headachehead pain	3,333	13.9%
Duodenal ulcer perforation	3,162	13.2%
Helicobacter infection	3,159	13.2%
Diarrhoealoose or frequent stools	3,066	12.8%
Infectionan infection, type not specified	2,972	12.4%
Mobility decreasedreduced ability to move about	2,812	11.7%
Rheumatoid factor positive	2,810	11.7%
General physical health deteriorationgeneral decline in health	2,779	11.6%
Hypertensionhigh blood pressure	2,772	11.5%
Vomitingbeing sick	2,643	11%
Nasopharyngitisa cold	2,628	10.9%
Blistera blister	2,621	10.9%
Malaisegeneral feeling of being unwell	2,580	10.7%
Psoriatic arthropathy	2,565	10.7%
Weight increasedweight gain	2,559	10.7%

Download all 1,186 terms of Hydroxychloroquine sulfate (CSV)

The counts add to more than 24,018 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Hydroxychloroquine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Hydroxychloroquine	Generic name	40,514
Hydroxychloroquine sulfate (this page)	Generic name	24,018
Plaquenil	Brand name	21,540

Sum of the separately reported names: 86,072. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Hydroxychloroquine sulfate, 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	39	35	14	1	16	1	2	9	4
2005	39	33	4	3	15	6	1	17	6
2006	26	24	4	2	11	0	0	12	2
2007	60	57	2	3	17	1	1	37	3
2008	67	57	7	6	27	5	0	23	10
2009	92	82	11	6	25	6	0	46	10
2010	96	91	6	10	43	2	6	42	5
2011	170	162	49	8	76	4	0	65	8
2012	195	190	34	18	68	7	20	103	5
2013	66	57	11	2	27	1	0	40	9
2014	75	62	10	8	24	0	0	42	13
2015	104	91	15	2	21	7	0	60	13
2016	202	179	7	15	49	7	4	130	23
2017	218	189	4	22	47	6	0	165	29
2018	402	374	14	21	72	12	4	334	28
2019	1,971	1,915	18	41	253	92	5	1,809	56
2020	5,325	5,274	73	152	760	319	15	4,755	51
2021	4,936	4,871	52	160	760	763	18	4,537	65
2022	3,324	3,290	174	260	788	787	29	2,930	34
2023	1,604	1,575	245	341	651	486	92	1,429	29
2024	1,876	1,839	877	981	1,229	1,120	371	1,733	37
2025	2,096	2,048	1,171	1,201	1,429	1,322	705	1,940	48
2026	1,035	1,015	635	660	744	684	458	973	20

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 Hydroxychloroquine sulfate, 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 Hydroxychloroquine sulfate, by the year in which FDA received them
Year	Reports
2004	35
2005	41
2006	26
2007	66
2008	64
2009	94
2010	94
2011	154
2012	224
2013	67
2014	79
2015	197
2016	567
2017	690
2018	1,114
2019	2,410
2020	5,987
2021	3,925
2022	2,610
2023	1,400
2024	1,948
2025	1,671
2026	555

Reports that name Hydroxychloroquine sulfate, 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 Hydroxychloroquine sulfate
Age	Reports	Share
Under 2	41	0.2%
2 to 11	165	0.7%
12 to 17	127	0.5%
18 to 44	5,154	21.5%
45 to 64	5,407	22.5%
65 to 74	1,598	6.7%
75 and over	720	3%
Age not given	10,806	45%

Sex of the patient in the reports that name Hydroxychloroquine sulfate
Sex	Reports	Share
Female	17,172	71.5%
Male	2,302	9.6%
Unknown or not given	4,544	18.9%

Type of reporter in the reports that name Hydroxychloroquine sulfate
Reporter	Reports	Share
Physician	4,139	17.2%
Pharmacist	226	0.9%
Other health professional	15,221	63.4%
Lawyer	2	under 0.1%
Consumer or non-health professional	4,223	17.6%
Not given	207	0.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 6.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Hydroxychloroquine sulfate record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	11,106	46.2%
Systemic lupus erythematosus	1,089	4.5%
Covid-19	390	1.6%
Juvenile idiopathic arthritis	168	0.7%
Foetal exposure during pregnancy	144	0.6%
Covid-19 pneumonia	95	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 24,018 reports.

Drugs in the same reports

Other drugs that the reports of Hydroxychloroquine sulfate name, in any role, in order of name
Drug	Reports that name the two
Actemra	13,922
Arava	12,470
Enbrel	16,679
Humira	15,163
Methotrexate	18,630
Orencia	15,530
Prednisone	13,551
Remicade	12,363
Rituximab	12,497
Sulfasalazine	14,268

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

Hydroxychloroquine same ingredient
Plaquenil same ingredient
Malarone same class
Chloroquine phosphate same class
Mepron same class
Atovaquone same class
Hydroxychloroquine Diphosphate next in the A to Z list
Hydroxychloroquine Sulfate Plaquenil next in the A to Z list
Hydroxydaunorubicin next in the A to Z list
Hydroxycarbamide next in the A to Z list
Hydroxyurea next in the A to Z list
Hydroxocobalamin next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Hydroxychloroquine sulfateThe 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. Hydroxychloroquine sulfate: adverse event reports that FDA received. https://reportedreactions.com/drug/hydroxychloroquine-sulfate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Hydroxychloroquine sulfate as a suspect or interacting product. The 16,145 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 Hydroxychloroquine sulfate 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 Hydroxychloroquine sulfate?

No. It is a count of what people reported to FDA: 24,018 reports from January 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 (63.4%), consumer or non-health professional (17.6%) and physician (17.2%). 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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