No black box warning on record for Warfarin

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

Other warnings & precautions

Category X in Pregnancy: Warfarin crosses the placenta and can cause fetal warfarin syndrome (nasal hypoplasia, stippled epiphyses) in first trimester, and intracranial hemorrhage in second/third trimester. CONTRAINDICATED in pregnancy. Heparin/LMWH is used instead.
Bleeding Risk: Risk is highest in elderly, patients with history of bleeding, poorly controlled INR, concurrent antiplatelet medicines, or liver disease. The key to safe warfarin use is meticulous INR monitoring.
INR Monitoring: INR must be checked frequently — every few days when initiating or changing doses, every 1–4 weeks once stable. Target INR for most indications is 2.0–3.0; for mechanical mitral valves, 2.5–3.5.
Reversal: Warfarin anticoagulation can be reversed by Vitamin K1 (phytonadione), fresh frozen plasma (FFP), or 4-factor prothrombin complex concentrate (PCC) — the latter being fastest for emergent reversal.

No black box warning on record for Warfarin

Other warnings & precautions

Category X in Pregnancy: Warfarin crosses the placenta and can cause fetal warfarin syndrome (nasal hypoplasia, stippled epiphyses) in first trimester, and intracranial hemorrhage in second/third trimester. CONTRAINDICATED in pregnancy. Heparin/LMWH is used instead.
Bleeding Risk: Risk is highest in elderly, patients with history of bleeding, poorly controlled INR, concurrent antiplatelet medicines, or liver disease. The key to safe warfarin use is meticulous INR monitoring.
INR Monitoring: INR must be checked frequently — every few days when initiating or changing doses, every 1–4 weeks once stable. Target INR for most indications is 2.0–3.0; for mechanical mitral valves, 2.5–3.5.
Reversal: Warfarin anticoagulation can be reversed by Vitamin K1 (phytonadione), fresh frozen plasma (FFP), or 4-factor prothrombin complex concentrate (PCC) — the latter being fastest for emergent reversal.

Warfarin Black Box Warning

No black box warning on record for Warfarin

Other warnings & precautions

Warfarin Black Box Warning

No black box warning on record for Warfarin

Other warnings & precautions