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ACUTE EXPOSURE INFORMATION

  1. WITH THERAPEUTIC USE
    1. The most common adverse effects are headache, back pain, dyspepsia, and myalgia. Other adverse effects that may occur include nasal congestion, flushing, and limb pain.
    1. The following adverse effects have also been reported RARELY: Angina pectoris, chest pain, hypotension, hypertension, myocardial infarction, postural hypotension, palpitations, syncope, and tachycardia, rash, pruritus, increased sweating, diarrhea, dry mouth, dysphagia, esophagitis, gastroesophageal reflux, gastritis, nausea, vomiting, and upper abdominal pain, dyspnea, epistaxis and pharyngitis, abnormal liver enzymes, changes in color vision, dizziness, hypesthesia, insomnia, paresthesia, somnolence, and vertigo. A causal relationship of these events to tadalafil is uncertain.
  1. WITH POISONING/EXPOSURE
    1. Overdose data is limited. Following the administration of single doses up to 500 mg to healthy volunteers or multiple daily doses up to 100 mg to patients, adverse effects were similar to those observed at lower doses.
    1. Intracerebral hemorrhage was associated with tadalafil (40 mg dose) use in an adult. No permanent sequelae was reported.
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