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What the label lists and what reports show

Chloroquine side effects

Chloroquine's FDA label lists its adverse reactions in its own words. FAERS holds 654 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 nausea (49 reports).

  • Generic listed

Check it at the source: the chloroquine FDA label on DailyMed (effective July 2, 2026, Rising Pharma Holdings, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse reactions have been identified during post-approval use of chloroquine or other 4-aminoqunoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular disorders: Maculopathy and macular degeneration have been reported and may be irreversible. Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance) and visual field defects (paracentral scotomas) in patients receiving long-term or high-dosage 4-aminoquinoline therapy have been reported (see WARNINGS ). Visual disturbances (blurring of vision and difficulty of focusing or accommodation); nyctalopia; …

Source: FDA drug label, Rising Pharma Holdings, Inc., effective July 2, 2026 (SPL set 06c69e2b-211b-4746-9f3a-f86d36520570), via openFDA; the full label on DailyMed

What do FAERS reports show?

654 reports list chloroquine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 146 are coded as a death and 341 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 21 reactions below, 3 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

  • Off Label Use (a use or a product term, not a reaction)63
  • Nausea (named in the label)49
  • Vomiting (named in the label)49
  • Hypertension42
  • Headache41
  • Pneumonia40
  • Pyrexia40
  • Fatigue39
  • Pain38
  • Toxicity To Various Agents36
  • Hypoxia32
  • Drug Ineffective (a use or a product term, not a reaction)31
  • Intentional Overdose (a use or a product term, not a reaction)31
  • Abdominal Pain30
  • Dyspnoea29
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)29
  • Arthralgia27
  • Asthenia27
  • Cardiac Arrest26
  • Confusional State24
  • Tachypnoea24
  • Pulmonary Oedema23
  • Rash (named in the label)23
  • Alopecia22
  • Atrioventricular Block Complete22

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

What next?

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