Partial
Mostly Aligned
Patient Risk:
Medium
Summary
Some safety-related claims (stroke, certain malignancies; application to skin; estradiol content; common adverse reactions like headache/breast pain/nausea) are supported by the supplied label text. However, core indication-related claims cannot be verified because Section 1 content is missing, one common adverse effect (application-site skin irritation) is not supported by the supplied label sections, and the response includes non-label pricing/coupon claims that are unrelated to FDA prescribing information.
Category Scores
Accurate Statements
Divigel is applied to the skin.
11 DESCRIPTION: “gel … when applied once daily to the skin”
Divigel is a transdermal gel containing estradiol.
11 DESCRIPTION: active component estradiol; applied once daily to skin on thigh
Common side effects of Divigel can include breast pain.
17 PATIENT COUNSELING INFORMATION: “breast pain and tenderness”
Common side effects of Divigel can include nausea.
17 PATIENT COUNSELING INFORMATION: “nausea and vomiting”
Common side effects of Divigel can include headache.
17 PATIENT COUNSELING INFORMATION: “such as headaches”
More serious side effects of Divigel may include stroke.
5.1 Cardiovascular Disorders: stroke risk discussion and contraindication language referencing stroke
More serious side effects of Divigel may include certain types of cancer.
5.2 Malignant Neoplasms: endometrial and breast cancer; also ovarian cancer section present
Unsupported Statements
Divigel is used to treat low estrogen levels in women.
Not supported by the supplied label sections; Section 1 content is missing and no provided sections describe treating “low estrogen levels.”
Common side effects of Divigel can include skin irritation at the application site.
Not mentioned in the supplied label text (patient counseling provided lists headaches, breast pain/tenderness, nausea/vomiting, but not application-site skin irritation).
GoodRx has listed prices for Divigel 0.5 mg 30-count packets, with the lowest reported price being $388.98 for 30 packets.
Pricing/marketplace information is not part of FDA prescribing information in the supplied label sections.
A coupon could lower the price of 30 packets of 0.5 mg Divigel to $319.48, compared to the list price of $388.98.
Pricing/coupon information is not part of FDA prescribing information in the supplied label sections.
Contradictions
Low
AI Statement
Label Reference
Important Omissions
Core approved indication(s) and detailed dosage/administration instructions cannot be verified because Section 1 and Section 2 are provided only as <text/> in the prompt.
Importance:
High
Whether/which boxed warning content applies is not assessable because the supplied material does not include the Boxed Warning section text.
Importance:
Moderate
Exact description of serious thromboembolic events is not confirmed with the response wording “blood clots” (label discusses DVT/PE/stroke rather than the generic phrase).
Importance:
Low
Safety Assessment
Potential Patient Risk:
Medium
The response includes multiple non-label pricing/coupon claims and omits/does not verify core indication and dosing information due to missing label sections. Safety-related statements are partially supported (stroke and malignancies), but one common adverse effect is unsupported (application-site skin irritation).
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Mostly Aligned
Primary Issue
Cannot verify approved indications or dosing because Section 1 and Section 2 label text are missing; includes unsupported adverse effect claim and non-label pricing/coupon statements.
Suggested Improvement
Remove pricing/coupon claims and only state label-supported clinical/safety information; provide and align with the missing Section 1 (Indications) and Section 2 (Dosage/Administration) content before describing treatment purpose.