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Hydroxychloroquine Side Effects

The most commonly reported side effects of hydroxychloroquine include rheumatoid arthritis, off label use, and pain, based on 156,265 FDA adverse event reports from 2004 to 2025. 26.7% of reports found the drug to be ineffective.

Hydroxychloroquine side effects

Percentages show how often each reaction appears relative to total reports for hydroxychloroquine.

1
Drug Ineffective26.7%41,700
2
Rheumatoid Arthritis16.9%26,366
3
Off Label Use14.3%22,399
4
Pain13.8%21,519
5
Arthralgia11.6%18,202
6
Fatigue11.6%18,115
7
Drug Intolerance10.6%16,506
8
Joint Swelling10.1%15,814
9
Rash8.8%13,769
10
Nausea8.1%12,681
11
Condition Aggravated7.8%12,175
12
Abdominal Discomfort7.6%11,840
13
Alopecia7.5%11,741
14
Contraindicated Product Administered7.5%11,669
15
Headache7.1%11,170

These are voluntary reports and do not establish that hydroxychloroquine caused these reactions.

Report severity

77.7%Serious121,365 reports
25.7%Hospitalizations40,083 reports
7.4%Fatal11,632 reports

Seriousness is determined by the reporter, not by OpenClaim.

Hydroxychloroquine drug interactions

Other drugs that appear in adverse event reports alongside hydroxychloroquine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methotrexate33.1%51,724
2
Etanercept30.2%47,181
3
Adalimumab26.1%40,713
4
Leflunomide22.4%35,006
5
Abatacept20.3%31,745
6
Tocilizumab19.6%30,662
7
Rituximab18.7%29,261
8
Sulfasalazine16.4%25,630
9
Infliximab15.6%24,416
10
Prednisone14.0%21,823
11
Certolizumab-pegol12.2%19,073
12
Tofacitinib11.6%18,168
13
Golimumab11.1%17,302
14
Folic-acid8.0%12,448
15
Alendronate-sodium7.6%11,884

Taken alongside

1
Prednisone20.7%32,272
2
Methotrexate16.7%26,065
3
Acetaminophen13.9%21,644
4
Folic-acid12.9%20,213
5
Ergocalciferol10.7%16,769
6
Sulfasalazine8.6%13,370
7
Levothyroxine-sodium8.2%12,815
8
Tofacitinib7.9%12,361
9
Pantoprazole-sodium7.7%12,003
10
Leflunomide7.4%11,595
11
Omeprazole6.4%10,053
12
Aspirin6.2%9,721
13
Ibuprofen6.2%9,718
14
Gabapentin5.5%8,546
15
Calcium5.4%8,482

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports hydroxychloroquine side effects

72.5% of hydroxychloroquine adverse event reports involve female patients and 16.2% involve male patients. The largest age group is adult at 70%. These figures reflect who reports side effects, not underlying risk.

Sex

Female72.5%
Male16.2%
Unknown11.3%

Age group

< 21.0%
2–110.9%
12–171.3%
18–6469.6%
65+27.2%

What is hydroxychloroquine used for

Conditions and purposes for which patients were taking hydroxychloroquine when the adverse event was reported.

1p36 Deletion SyndromeAbdominal DiscomfortAbortion SpontaneousAcute Cutaneous Lupus ErythematosusAcute Febrile Neutrophilic DermatosisAcute Kidney InjuryAcute Respiratory Distress SyndromeAcute Respiratory FailureAdenocarcinomaAdenocarcinoma PancreasAdjuvant TherapyAdverse Drug ReactionAlopeciaAlopecia AreataAlopecia Scarring

Showing 15 of 1,426 indications

Hydroxychloroquine brand names and reporting trend

Hydroxychloroquine is sold under the brand name Plaquenil.

Brand names

Plaquenil190,662

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking hydroxychloroquine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.