FDA Black-Box Warning
WARNING: TORSADES DE POINTES AND SUDDEN DEATH
Cases of torsades de pointes (a life-threatening abnormal heart rhythm), cardiac arrest, and death have been reported with the use of a higher-than-recommended dosages of loperamide.
Loperamide is contraindicated in pediatric patients younger than 2 years of age.
Avoid higher-than-recommended dosages of loperamide in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions.
Ask a doctor or pharmacist before use if you are taking antibiotics.
When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.
Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.