FDA Section 4 \u2022 who must NOT take this
Isotretinoin - Contraindications
These conditions, allergies, and situations mean Isotretinoin should NOT be used. From the US FDA-approved drug label Section 4.
CONTRAINDICATIONS Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS .
Allergic Reactions Isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see PRECAUTIONS: Hypersensitivity ).