Warfarinside effects
warfarin sodium 4 MG Oral Tablet [Jantoven]
Adverse reactions
The following serious adverse reactions to JANTOVEN are discussed in greater detail in other sections of the labeling: Hemorrhage Tissue Necrosis Calciphylaxis Acute Kidney Injury Systemic Atheroemboli and Cholesterol Microemboli Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS Other Clinical Settings with Increased Risks Other adverse reactions to JANTOVEN include: Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions) Vascular disorders: vasculitis Hepatobiliary disorders: hepatitis, elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine.
Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia Respiratory disorders: tracheal or tracheobronchial calcification General disorders: chills Most common adverse reactions to Warfarin Sodium are fatal and nonfatal hemorrhage from any tissue or organ. To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 8, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Contraindications
JANTOVEN is contraindicated in: Pregnancy JANTOVEN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism. JANTOVEN can cause fetal harm when administered to a pregnant woman. JANTOVEN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If JANTOVEN is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. JANTOVEN is contraindicated in patients with: Hemorrhagic tendencies or blood dyscrasias Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces Bleeding tendencies associated with: Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract Central nervous system hemorrhage Cerebral aneurysms, dissecting aorta Pericarditis and pericardial effusions Bacterial endocarditis Threatened abortion, eclampsia, and preeclampsia Unsupervised patients with conditions associated with potential high level of non-compliance Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) Major regional or lumbar block anesthesia Malignant hypertension Pregnancy, except in women with mechanical heart valves Hemorrhagic tendencies or blood dyscrasias Recent or contemplated surgery of the central nervous system (CNS) or eye, or traumatic surgery resulting in large open surfaces Bleeding tendencies associated with certain conditions Threatened abortion, eclampsia, and preeclampsia Unsupervised patients with potential high levels of non-compliance Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding Hypersensitivity to warfarin or any component of the product Major regional or lumbar block anesthesia Malignant hypertension
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 8, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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