Partial
Mostly Aligned
Patient Risk:
Moderate
Summary
Some drug-label-aligned claims about indications for nausea/vomiting (including gastroenteritis) are consistent with the provided label excerpt, but multiple claims concern pricing/insurance/generics which are not supported by the supplied FDA label text and therefore cannot be validated against it.
Category Scores
Accurate Statements
Tigan is the brand name for thiethylperazine.
Not supported by the provided label excerpts: the supplied label text indicates the active ingredient as trimethobenzamide hydrochloride, not thiethylperazine.
Thiethylperazine is an anti-nausea/antiemetic.
Not supported by the provided label excerpts because the supplied label excerpts do not identify thiethylperazine as the active ingredient; they reference trimethobenzamide hydrochloride.
Tigan (thiethylperazine) is used to help with nausea and vomiting.
Supported by SECTION 1 — INDICATIONS in the supplied label excerpt: “Tigan® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.”
Tigan (thiethylperazine) is used for nausea and vomiting including cases related to gastroenteritis.
Supported by SECTION 1 — INDICATIONS in the supplied label excerpt: “…nausea associated with gastroenteritis.”
Unsupported Statements
Tigan is the brand name for thiethylperazine.
The provided label excerpts identify Tigan® with active ingredient language as trimethobenzamide hydrochloride; thiethylperazine is not supported by the supplied label text.
Thiethylperazine is an anti-nausea/antiemetic.
The provided label excerpts do not support thiethylperazine as the active ingredient or explicitly link thiethylperazine to the labeled drug; label text references trimethobenzamide hydrochloride.
The cost of Tigan can vary by country and pharmacy.
No pricing/coverage/country/pharmacy cost information is present in the supplied label excerpts.
The cost of Tigan can vary by formulation (e.g., tablets vs. injection).
No pricing/formulation cost information is present in the supplied label excerpts; the label excerpts provided focus on an injectable form.
The cost of Tigan can vary by dose strength and pack size.
No pricing/pack size/dose strength cost information is present in the supplied label excerpts.
Whether a person has insurance or a subsidy affects the cost of Tigan.
No insurance/subsidy/cost-adjustment information is present in the supplied label excerpts.
The cost of Tigan can vary depending on whether it is brand-name only or if there are local generics.
No brand/generic pricing or local generic availability information is present in the supplied label excerpts.
Generic thiethylperazine may be lower cost than the brand.
No pricing or generic-brand comparison information is present in the supplied label excerpts, and thiethylperazine is not supported as the active ingredient for Tigan in the provided label text.
Other antiemetics may have different pricing in a market.
No comparative pricing or market pricing information is present in the supplied label excerpts.
Contradictions
High
AI Statement
Tigan is the brand name for thiethylperazine.
Label Reference
Provided label excerpts reference Tigan® as trimethobenzamide hydrochloride (e.g., SECTION 5/CLINICAL PHARMACOLOGY excerpts).
High
AI Statement
Thiethylperazine is an anti-nausea/antiemetic.
Label Reference
Provided label excerpts discuss Tigan® (trimethobenzamide hydrochloride) and its antiemetic indications; thiethylperazine is not supported as the active ingredient in the provided label text.
Important Omissions
The label provided includes key administration limitations (injectable form intended for intramuscular administration only; not recommended for intravenous use; not for use in pediatric patients) and dosing (2 mL/200 mg t.i.d. or q.i.d.). None of the claims address these label-specific administration/dosing constraints.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Incorrect identification of active ingredient as thiethylperazine (instead of trimethobenzamide hydrochloride per provided label excerpts) could lead to medication misidentification; pricing-related statements are non-label and could distract from safe label-based use.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Active ingredient mismatch: claims identify thiethylperazine, while the supplied label excerpts indicate trimethobenzamide hydrochloride for Tigan®.
Suggested Improvement
Replace thiethylperazine references with trimethobenzamide hydrochloride as indicated in the provided label text; remove or qualify non-label pricing/insurance/generic-cost claims since they are not supported by the supplied FDA label excerpts.