FDA Section 5 \u2022 cited verbatim

Acyclovir - Warnings and Precautions

The following warnings and precautions are taken directly from the US FDA-approved drug label for Acyclovir. This is the same information dispensing pharmacists read.

WARNINGS Acyclovir tablets are intended for oral ingestion only.

Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE ).

Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.

Severe cutaneous adverse reactions (SCARs), including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme (EM) have been reported with acyclovir (see CONTRAINDICATIONS and ADVERSE REACTIONS ).

Discontinue acyclovir tablets immediately if a painful rash with mucosal involvement or a progressive severe rash develops.

Closely monitor clinical status and initiate appropriate therapy.

Acyclovir tablets are contraindicated in patients who have developed SCARs with the use of acyclovir or valacyclovir, or any component of the formulation (see CONTRAINDICATIONS and ADVERSE REACTIONS ).

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