Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Many listed adverse effects and CNS/renal risks are consistent with the provided adverse-reactions/warnings excerpts, and contraindication/pregnancy-breastfeeding cautions are directionally aligned. However, several items are not supported by the provided label excerpts (notably specific interactions and alcohol advice), and the statement about “kidney damage or kidney failure in rare cases” is not precisely supported as phrased.
Category Scores
Accurate Statements
Acyclovir can cause nausea and vomiting.
SECTION 6 — Herpes Simplex (Short-Term Administration): “nausea and/or vomiting…”.
Acyclovir can cause diarrhea.
SECTION 6 — Herpes Simplex (Long-Term Administration): “nausea (4.8%) and diarrhea (2.4%).” and SECTION 6 — Chickenpox: diarrhea reported.
Acyclovir can cause rash.
SECTION 6 — Observed during clinical practice includes systemic adverse events (anaphylaxis/angioedema noted); rash is not explicitly shown in the provided excerpts.
Acyclovir can cause allergic reactions.
SECTION 6 — “In addition to adverse events… identified… (e.g., anaphylaxis/angioedema).”
Long-term use of acyclovir can cause kidney damage or kidney failure in rare cases.
SECTION 6 — “Renal failure… identified…” and SECTION 5 — “Renal failure, in some cases resulting in death, has been observed…” (but rarity phrasing not provided).
Acyclovir can cause neurological problems such as confusion, agitation, or hallucinations.
SECTION 6 — “Nervous… confusion… hallucinations…” (agitation not explicitly shown in excerpt).
Acyclovir can cause seizures.
SECTION 6 — “...seizures…”
Seizures from acyclovir can occur especially in individuals with a history of seizure disorders.
No provided excerpt includes “especially” or seizure-disorder history linkage.
Acyclovir can be used during pregnancy, but risks and benefits should be discussed with a healthcare provider.
SECTION 8 — Pregnancy: “Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”
Acyclovir can be used during breastfeeding, but risks and benefits should be discussed with a healthcare provider.
SECTION 8 — Nursing Mothers: “Acyclovir should be administered… with caution and only when indicated.”
Individuals with kidney disease should use acyclovir with caution because it can exacerbate kidney problems.
SECTION 5 — Renal failure observed with therapy; SECTION 2 — renal impairment dosing modification exists; (explicit “caution” phrasing not provided, but renal impairment management is supported).
Unsupported Statements
Acyclovir can cause headache.
No headache adverse event is explicitly present in the provided SECTION 6 excerpts.
Acyclovir can cause fatigue or weakness.
No fatigue/weakness adverse event is explicitly present in the provided SECTION 6 excerpts.
Acyclovir can cause dizziness or lightheadedness, especially when standing up quickly.
No dizziness/lightheadedness/orthostatic phrasing is explicitly present in the provided excerpts.
Acyclovir can cause abdominal pain, cramping, or discomfort.
No abdominal pain/cramping adverse event is explicitly present in the provided excerpts.
Acyclovir can cause rash.
Rash is not explicitly included in the provided SECTION 6 excerpts.
Allergic reactions to acyclovir can manifest as hives, itching, swelling, or difficulty breathing.
The provided excerpts mention anaphylaxis/angioedema but do not explicitly list hives/itching or difficulty breathing as manifestations.
Seizures from acyclovir can occur especially in individuals with a history of seizure disorders.
The provided excerpts do not link seizure risk to prior seizure disorders.
Acyclovir can increase the risk of infections in individuals with weakened immune systems.
No such statement appears in the provided excerpts.
Acyclovir can interact with other medications, including antacids.
No antacid interaction is provided in the provided SECTION 7 excerpt.
Acyclovir can interact with other medications, including blood thinners.
No anticoagulant/blood thinner interaction is provided in the provided SECTION 7 excerpt.
Acyclovir can interact with other medications, including immunosuppressants.
No immunosuppressant interaction is provided in the provided SECTION 7 excerpt.
Avoiding alcohol while taking acyclovir can reduce the risk of side effects.
No alcohol guidance is present in the provided excerpts.
Acyclovir can cause liver damage in rare cases.
No liver damage/hepatotoxicity statement is present in the provided excerpts.
Individuals with liver disease should use acyclovir with caution.
No liver-disease caution is present in the provided excerpts.
Acyclovir can increase the risk of infections in individuals with weakened immune systems.
The provided excerpts only mention TTP/HUS in immunocompromised patients receiving acyclovir, not infection risk.
Contradictions
Important Omissions
No mention of specific boxed warning or boxed-warning content (if any) and no discussion of TTP/HUS details beyond general safety assertions.
Importance:
Low
No statement that acyclovir oral suspension is for oral ingestion only / specific administration constraints.
Importance:
Low
Safety Assessment
Potential Patient Risk:
Moderate
Most safety effects listed (GI effects, seizures/CNS effects, renal failure) are directionally supported by the provided label excerpts, but several items are unsupported (e.g., alcohol avoidance, specific interaction examples antacids/blood thinners/immunosuppressants, liver-disease/liver damage) which could mislead patients or prescribers.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Multiple statements are not supported by the supplied label excerpts, particularly drug interaction examples and alcohol avoidance; some adverse effects are listed without explicit label support.
Suggested Improvement
Restrict claims to adverse reactions and interaction information explicitly supported by the provided FDA label excerpts (e.g., nausea/vomiting, diarrhea, renal failure, confusion/hallucinations/seizures). Remove or rephrase unsupported statements (antacids, blood thinners, immunosuppressants, alcohol avoidance, liver damage, infection risk in immunocompromised patients).