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What the label lists and what reports show

Hydroxychloroquine side effects

Hydroxychloroquine's FDA label: “The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain.” FAERS holds 151,392 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (21,906 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the hydroxychloroquine FDA label on DailyMed (effective October 8, 2024, ANI Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain.

From the label: adverse reactions, continued

The following adverse reactions are described in greater detail in other sections: Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions (5.1)] Retinal Toxicity [see Warnings and Precautions (5.2)] Serious Skin Reactions [see Warnings and Precautions (5.3)] Worsening of Psoriasis [see Warnings and Precautions (5.4)] Risks Associated with Use in Porphyria [see Warnings and Precautions (5.5)] Hematologic Toxicity [see Warnings and Precautions (5.6)] Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.7)] Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8)] Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9)] Hypoglycemia [see Warnings and Precautions (5.10)] Renal Toxicity [see Warnings and Precautions (5.11)] The following adverse reactions have been identified during post-approval use of 4­ aminoquinoline drugs, including SOVUNA.

Source: FDA drug label, ANI Pharmaceuticals, Inc., effective October 8, 2024 (SPL set dd441154-b196-4d4c-bc56-2e37f345ef8d), via openFDA; the full label on DailyMed

What do FAERS reports show?

151,392 reports list hydroxychloroquine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11,802 are coded as a death and 39,120 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)41,581
  • Rheumatoid Arthritis (a use or a product term, not a reaction)26,858
  • Off Label Use (a use or a product term, not a reaction)22,429
  • Pain21,906
  • Fatigue (named in the label)18,669
  • Arthralgia18,631
  • Drug Intolerance16,606
  • Joint Swelling15,987
  • Rash (named in the label)14,199
  • Nausea (named in the label)13,206
  • Condition Aggravated (a use or a product term, not a reaction)12,333
  • Abdominal Discomfort12,031
  • Alopecia (named in the label)11,979
  • Contraindicated Product Administered11,762
  • Headache (named in the label)11,621
  • Systemic Lupus Erythematosus (a use or a product term, not a reaction)11,518
  • Synovitis11,012
  • Arthropathy10,807
  • Diarrhoea (named in the label)10,454
  • Treatment Failure (a use or a product term, not a reaction)10,420
  • Swelling10,180
  • Drug Hypersensitivity9,761
  • Peripheral Swelling9,537
  • Hypersensitivity9,046
  • Pemphigus8,995

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Hydroxychloroquine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions