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What the label lists and what reports show

Atropine side effects

Atropine's FDA label lists its adverse reactions in its own words. FAERS holds 12,238 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 diarrhoea (729 reports).

  • Generic listed
  • In shortage

Check it at the source: the atropine FDA label on DailyMed (effective May 18, 2026, Hospira, 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 atropine sulfate. 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. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation. Most adverse reactions are directly related to atropine’s antimuscarinic action. …

Source: FDA drug label, Hospira, Inc., effective May 18, 2026 (SPL set ad8916e7-206e-409e-2582-30d072845dd4), via openFDA; the full label on DailyMed

What do FAERS reports show?

12,238 reports list atropine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,405 are coded as a death and 5,287 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, 5 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)931
  • Death (an outcome recorded in the report)909
  • Off Label Use (a use or a product term, not a reaction)782
  • Diarrhoea729
  • Nausea (named in the label)696
  • Fatigue590
  • Hypotension586
  • Pain533
  • Dyspnoea488
  • Vomiting (named in the label)480
  • Pyrexia459
  • Bradycardia (named in the label)455
  • Headache379
  • Cardiac Arrest (a use or a product term, not a reaction)377
  • Constipation (named in the label)370
  • Toxicity To Various Agents368
  • Fall346
  • Hypertension309
  • Abdominal Pain308
  • Asthenia308
  • Malaise308
  • Drug Interaction (a use or a product term, not a reaction)307
  • Pneumonia301
  • Tachycardia (named in the label)278
  • Condition Aggravated (a use or a product term, not a reaction)274

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

What next?

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