Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Some safety/administration concepts (sedation/drowsiness and driving caution; CNS-depressant interaction; rapid absorption timing after oral dosing) are consistent with the provided label excerpts, but multiple claims are unsupported or not substantiated by the supplied label text (e.g., mechanism as H1 blockade, specific adverse effects like dry mouth/constipation/irregular heartbeat/fainting/urinary trouble/confusion, missed-dose guidance, onset/duration beyond what is stated, and several 'caution' statements not present).
Category Scores
Accurate Statements
Hydroxyzine is taken by mouth.
SECTION 12 notes rapid absorption from the gastrointestinal tract and oral administration effects usually noted within 15 to 30 minutes after oral administration.
Drowsiness may occur with use of this drug, and patients should be cautioned against driving or operating dangerous machinery while taking Atarax.
SECTION 5: 'Since drowsiness may occur... cautioned against driving a car or operating dangerous machinery while taking Atarax.'
Avoid alcohol with hydroxyzine (alcohol effect may be increased).
SECTION 5: 'cautioned that the effect of alcohol may be increased.'
Use caution with other medicines that cause drowsiness (CNS depressants).
SECTION 5: warnings about simultaneous use of other CNS depressant drugs; and 'THE POTENTATING ACTION... must be considered... when... used in conjunction with... CNS depressants such as narcotics... non-narcotic analgesics and barbiturates' with dose reduction guidance.
Hydroxyzine may potentiate other CNS depressants (label requires considering potentiating action and reducing concomitant CNS depressant doses).
SECTION 5: 'THE POTENTATING ACTION... MUST BE CONSIDERED...' and 'Therefore when central nervous system depressants are administered concomitantly... their dosage should be reduced.'
Hydroxyzine's clinical effects after oral administration are usually noted within 15 to 30 minutes.
SECTION 12: 'effects are usually noted within 15 to 30 minutes after oral administration.'
Unsupported Statements
Hydroxyzine HCl 25 mg is an antihistamine.
Label excerpts do not explicitly state 'antihistamine' as a definition; they mention 'anti- histaminic... effects' but the statement as phrased is not directly supported.
Hydroxyzine blocks histamine at H1 receptors.
No H1 receptor blockade mechanism is described in the provided label excerpts.
Blocking H1 receptors reduces itching and allergic reactions.
Label excerpt supports pruritus management, but the specific 'H1 blockade reduces itching/allergic reactions' causal mechanism is not stated.
Hydroxyzine affects other brain receptors.
The provided label excerpt states action may be due to suppression of activity in certain subcortical CNS regions, but does not support 'other brain receptors' as a general receptor claim.
Hydroxyzine can cause sedation or drowsiness.
Label supports 'drowsiness may occur' and 'hypersedation' in overdosage, but the broader phrase 'can cause sedation or drowsiness' is partly supported; however, additional specificity in other statements indicates this is treated as not directly substantiated across all contexts.
Dosing of hydroxyzine depends on the condition being treated, age, and other health factors.
Label excerpt states dose should be adjusted according to patient's response, but does not explicitly list 'condition, age, and other health factors' in this general form.
If a dose of hydroxyzine is missed, do not take extra unless the prescriber tells you to.
No missed-dose guidance is present in the provided label excerpts.
Common side effects include dizziness, dry mouth, constipation, blurred vision, and common side effects such as drowsiness.
Provided label excerpt lists 'Anticholinergic: Dry mouth' and mentions mild/transitory side effects generally, but it does not list dizziness, constipation, blurred vision, or characterize them as 'common side effects' in the supplied text.
Because hydroxyzine can make you sleepy, driving or operating machinery is risky until you know how it affects you.
Label cautions against driving/operating dangerous machinery while taking Atarax, but the 'until you know how it affects you' nuance is not explicitly stated.
Hydroxyzine may cause severe confusion.
Label excerpt states sedating drugs may cause confusion and over-sedation in the elderly; 'severe confusion' specifically is not supported.
Hydroxyzine may cause fainting.
Not present in provided label excerpts.
Hydroxyzine may cause irregular heartbeat.
Not present in provided label excerpts.
Hydroxyzine may cause trouble urinating.
Not present in provided label excerpts.
Hydroxyzine begins to work within a relatively short time after a dose for many people.
Label provides a specific timing range for oral administration (15–30 minutes), but the general 'relatively short time for many people' is not directly stated as such.
The exact onset and duration... can vary by formulation and individual metabolism.
Label excerpt supports timing after oral administration but does not mention formulation-dependent onset or individual metabolism variability in the provided text.
Sedation from hydroxyzine may last several hours.
No sedation duration (several hours) is provided in the supplied excerpts.
Hydroxyzine can come in different formulations (e.g., tablets versus other dosage forms) and strengths.
Formulation/strength availability is not stated in the provided label excerpts.
Hydroxyzine HCl 25 mg refers specifically to the hydrochloride salt at that strength.
This appears chemically plausible but is not explicitly stated in provided label excerpts.
Hydroxyzine may cause trouble urinating and older adults may be more prone to sedation and falls.
Label excerpt mentions confusion and over-sedation in elderly, but does not mention falls or trouble urinating.
Extra caution is often needed for people with glaucoma.
Not present in provided label excerpts.
Extra caution is often needed for people with trouble urinating such as enlarged prostate.
Not present in provided label excerpts.
Extra caution is often needed for people with certain heart rhythm issues.
Not present in provided label excerpts.
Get urgent medical help if signs of an allergic reaction occur, such as swelling of the face/lips or trouble breathing.
Label excerpt provides hypersensitivity contraindication but does not include specific allergic reaction symptom triage language.
Combining sedating drugs increases the risk of impaired breathing.
No respiratory depression or impaired breathing risk is stated in the provided label excerpts.
Contradictions
Low
AI Statement
Hydroxyzine HCl 25 mg is an antihistamine.
Label Reference
Important Omissions
Indications are more specific: symptomatic relief of anxiety/tension associated with psychoneurosis; adjunct in organic disease states with anxiety; and pruritus due to allergic conditions including chronic urticaria and histamine-mediated pruritus; as well as premedication/following general anesthesia sedative use.
Importance:
Moderate
Contraindication in early pregnancy (contraindicated in early pregnancy until human safety data are available).
Importance:
Moderate
Specific dosing ranges by indication and age (e.g., anxiety 50–100 mg q.i.d. adults; pruritus 25 mg t.i.d. or q.i.d. adults; sedation 50–100 mg adults; pediatric mg/kg).
Importance:
Moderate
Geriatric precautions include starting low doses and close observation; label also notes uncertainty about sufficient elderly study numbers and renal excretion/dose selection caution due to decreased renal function.
Importance:
Moderate
Adverse reaction detail in the provided excerpts includes 'Dry mouth' (anticholinergic) and general statement that side effects are usually mild and transitory; does not enumerate the listed other specific adverse events.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Multiple safety-relevant specifics are unsupported or inaccurate relative to the provided label excerpts (e.g., 'impaired breathing' and several adverse events not supported; missed-dose and formulation/duration assertions not in excerpts). The core labeled warnings about drowsiness, driving caution, and CNS-depressant potentiation with alcohol are partially aligned.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Many mechanistic and adverse-effect claims are not supported by the provided label excerpts, and several safety statements (e.g., impaired breathing; multiple specific adverse events) are not present in the supplied prescribing information.
Suggested Improvement
Restrict claims to the provided label excerpts: anxiety/tension and pruritus indications as stated; dosing guidance limited to 'adjust according to response' and the specific labeled dose ranges; drowsiness/driver caution and alcohol/CNS depressant potentiation with dose reduction; cite only adverse reactions explicitly present (e.g., dry mouth) and the general 'mild and transitory' statement; include early pregnancy contraindication.