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What the label lists and what reports show

Carbachol side effects

Carbachol's FDA label lists its adverse reactions in its own words. FAERS holds 162 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 abdominal discomfort (28 reports).

  • No generic listed

Check it at the source: the carbachol FDA label on DailyMed (effective February 10, 2023, Alcon Laboratories, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Ocular: Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported. Systemic: Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and headache have been reported with topical or systemic application of carbachol. The following additional reactions have been identified during post-approval use of MIOSTAT (carbachol intraocular solution, USP) 0.01% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. …

Source: FDA drug label, Alcon Laboratories, Inc., effective February 10, 2023 (SPL set f28d7a56-e079-4a8b-ad81-9a97c780de67), via openFDA; the full label on DailyMed

What do FAERS reports show?

162 reports list carbachol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 49 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 20 reactions below, 1 is 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.

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)30
  • Abdominal Discomfort28
  • Drug Abuse27
  • Lower Respiratory Tract Infection27
  • Product Dose Omission Issue (a use or a product term, not a reaction)27
  • Amyloid Arthropathy26
  • Arthropathy26
  • Intentional Product Misuse (a use or a product term, not a reaction)26
  • Obesity26
  • Pulmonary Pain26
  • Rash26
  • Drug Dependence25
  • Endophthalmitis24
  • Overdose (a use or a product term, not a reaction)24
  • Knee Arthroplasty23
  • Drug Ineffective (a use or a product term, not a reaction)18
  • Visual Acuity Reduced16
  • Asthma13
  • Nasopharyngitis13
  • Toxic Anterior Segment Syndrome13
  • Asthenia12
  • Dyspnoea12
  • Ocular Hyperaemia (named in the label)12
  • Oedema Peripheral12
  • Pneumonia12

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

What next?

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