Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Some specific safety events (e.g., anaphylaxis, thrombocytopenia, hepatitis, seizure, psychiatric/neuro events) are supported by the provided label excerpts, but multiple generalized frequency/severity statements and several condition/definition-style claims (anaphylaxis characterization and symptoms; thrombocytopenia/neutropenia characterization; seizure risk framing) are not supported. Indication phrasing for 'cold sores'/'HSV infections' is not supported by the provided indications text.
Category Scores
Accurate Statements
Acyclovir can cause anaphylaxis.
ADVERSE REACTIONS > Observed During Clinical Practice > General: 'Anaphylaxis' (supports presence of event).
Acyclovir can cause thrombocytopenia.
ADVERSE REACTIONS > Observed During Clinical Practice > Hematologic and Lymphatic: 'thrombocytopenia'.
Acyclovir can cause hepatitis.
ADVERSE REACTIONS > Observed During Clinical Practice > Hepatobiliary Tract and Pancreas: 'hepatitis'.
Acyclovir can cause seizures.
ADVERSE REACTIONS > Observed During Clinical Practice > Nervous: 'seizure'.
Acyclovir can cause psychiatric side effects.
ADVERSE REACTIONS > Observed During Clinical Practice > Nervous: includes 'agitation', 'delirium', 'psychosis', etc.
Unsupported Statements
Acyclovir is prescribed to treat herpes simplex virus (HSV) infections, including cold sores, genital herpes, and shingles.
Provided INDICATIONS AND USAGE text supports genital herpes (initial and recurrent episodes) and herpes zoster (shingles) but does not support 'cold sores' or generic 'HSV infections' phrasing.
The most common side effects of acyclovir include headache, nausea, vomiting, diarrhea, abdominal pain, fatigue, and dizziness.
Provided ADVERSE REACTIONS excerpts show specific frequent events in particular trials (e.g., nausea/vomiting; diarrhea; malaise), and headache appears in one control group; the provided text does not support this complete list as 'most common' overall.
Acyclovir side effects are usually mild and temporary, resolving on their own within a few days.
No provided label text states that side effects are 'usually mild and temporary' or 'resolve on their own within a few days'.
Anaphylaxis is a severe, life-threatening allergic reaction that requires immediate medical attention.
The provided label excerpts list 'Anaphylaxis' but do not provide a definition or urgency/life-threatening characterization.
Anaphylaxis symptoms include difficulty breathing, rapid heartbeat, and swelling of the face, lips, or tongue.
No symptom list for anaphylaxis is provided in the supplied label excerpts.
Thrombocytopenia is a rare blood disorder characterized by a low platelet count that can increase the risk of bleeding.
The label excerpts list thrombocytopenia but do not state 'rare', provide a definition (low platelet count), or describe bleeding risk.
Acyclovir can cause neutropenia.
The provided adverse reaction excerpts include leukopenia but do not list 'neutropenia' specifically.
Neutropenia is a condition where the body produces too few neutrophils that can increase the risk of infection.
No definition for neutropenia is provided in the supplied label excerpts.
Acyclovir can cause acute kidney injury.
The provided excerpts use 'renal failure' rather than 'acute kidney injury'; acute kidney injury wording is not supported by the supplied text.
Acute kidney injury is a rare but potentially serious side effect that can occur in patients with pre-existing kidney disease.
The supplied WARNINGS/ADVERSE REACTIONS excerpts mention renal failure and fatal cases but do not state 'rare' or explicitly link to 'pre-existing kidney disease' in the provided text.
Hepatitis is a rare side effect that can occur in patients with pre-existing liver disease.
The provided label excerpts list hepatitis but do not state 'rare' or specifically 'pre-existing liver disease'.
Seizures are a rare side effect that can occur in patients with a history of seizures or other neurological disorders.
The provided label excerpts list seizure but do not state 'rare' or provide the specific risk-group framing (history of seizures/neurologic disorders).
Psychiatric side effects of acyclovir such as depression, anxiety, and psychosis have been reported in some patients taking acyclovir.
The label excerpt supports 'psychosis' and related events but does not mention 'depression' or 'anxiety'.
Rare but serious side effects of acyclovir include allergic reactions, blood disorders, kidney and liver problems, and neurological side effects.
The provided label excerpts include serious events across systems but do not characterize the combined set as 'rare' in the supplied text.
Common side effects of acyclovir include headache, nausea, vomiting, diarrhea, abdominal pain, fatigue, and dizziness.
The provided label excerpts do not support this full group as 'common side effects' overall.
Contradictions
Important Omissions
No label-supported contraindications, boxed warnings, dosage/administration details, or monitoring instructions were assessed because the supplied label excerpts did not include these sections.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Risk of misinterpretation arises from unsupported generalized frequency/severity claims ('most common', 'rare but serious', 'usually mild and temporary') and unsupported definition/symptom details, which could affect patient counseling or perceived risk. However, some specific serious events listed in the label are correctly mentioned.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Partially Aligned
Primary Issue
Multiple generalized and definition-style claims about frequency/severity and specific condition characterizations are not supported by the provided label excerpts.
Suggested Improvement
Remove or qualify unsupported generalizations (e.g., 'most common', 'common', 'rare', 'usually mild/temporary', 'resolve in a few days'); avoid non-label definitions and symptom lists for anaphylaxis/thrombocytopenia/neutropenia; align indication wording to the provided 'genital herpes' and 'herpes zoster (shingles)' indications only.