No black box warning on record for Ozanimod

As of the latest FDA labeling reviewed, Ozanimod (ozanimod) does not carry a black box warning. Standard warnings and precautions still apply — see the full Ozanimod medicine page for the complete safety profile.

Other warnings & precautions

Cardiovascular: do not initiate in patients with recent MI (within 6 months), unstable angina, stroke, TIA, decompensated heart failure, Class II–IV heart failure, history of Mobitz type II or third-degree AV block, sick sinus syndrome, or sinoatrial block (unless functioning pacemaker present). ECG required before first dose. First-dose observation period required (6 hours) in at-risk patients.
Infections: S1P modulators lower absolute lymphocyte count. Screen for varicella/VZV antibodies before initiation; vaccinate if seronegative. JC virus antibody status — monitor for PML risk.
Macular edema: ophthalmologic evaluation at baseline and with symptoms. Higher risk in diabetics and patients with prior uveitis.
Liver toxicity: monitor LFTs. Discontinue if significant elevation.
Pregnancy: teratogenic. Use effective contraception during treatment and for 3 months after stopping.
Immunosuppression: allow sufficient washout before starting other immunosuppressants.

No black box warning on record for Ozanimod

Other warnings & precautions

Cardiovascular: do not initiate in patients with recent MI (within 6 months), unstable angina, stroke, TIA, decompensated heart failure, Class II–IV heart failure, history of Mobitz type II or third-degree AV block, sick sinus syndrome, or sinoatrial block (unless functioning pacemaker present). ECG required before first dose. First-dose observation period required (6 hours) in at-risk patients.
Infections: S1P modulators lower absolute lymphocyte count. Screen for varicella/VZV antibodies before initiation; vaccinate if seronegative. JC virus antibody status — monitor for PML risk.
Macular edema: ophthalmologic evaluation at baseline and with symptoms. Higher risk in diabetics and patients with prior uveitis.
Liver toxicity: monitor LFTs. Discontinue if significant elevation.
Pregnancy: teratogenic. Use effective contraception during treatment and for 3 months after stopping.
Immunosuppression: allow sufficient washout before starting other immunosuppressants.

Ozanimod Black Box Warning

No black box warning on record for Ozanimod

Other warnings & precautions

Ozanimod Black Box Warning

No black box warning on record for Ozanimod

Other warnings & precautions