Jantoven (Warfarin Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Potential adverse reactions to Jantoven® Tablets (Warfarin Sodium Tablets, USP) may include:

• Fatal or nonfatal hemorrhage from any tissue or organ. This is a consequence of the anticoagulant effect. The signs, symptoms, and severity will vary according to the location and degree or extent of the bleeding. Hemorrhagic complications may present as paralysis; paresthesia; headache, chest, abdomen, joint, muscle or other pain; dizziness; shortness of breath, difficult breathing or swallowing; unexplained swelling; weakness; hypotension; or unexplained shock. Therefore, the possibility of hemorrhage should be considered in evaluating the condition of any anticoagulated patient with complaints which do not indicate an obvious diagnosis. Bleeding during anticoagulant therapy does not always correlate with PT/INR. (See OVERDOSAGE: Treatment.)
• Bleeding which occurs when the PT/INR is within the therapeutic range warrants diagnostic investigation since it may unmask a previously unsuspected lesion, e.g., tumor, ulcer, etc.
• Necrosis of skin and other tissues. (See WARNINGS.)
• Adverse reactions reported infrequently include: hypersensitivity/allergic reactions, including anaphylactic reactions, systemic cholesterol microembolization, purple toes syndrome, hepatitis, cholestatic hepatic injury, jaundice, elevated liver enzymes, hypotension, vasculitis, edema, anemia, pallor, fever, rash, dermatitis, including bullous eruptions, urticaria, angina syndrome, chest pain, abdominal pain including cramping, flatulence/bloating, fatigue, lethargy, malaise, asthenia, nausea, vomiting, diarrhea, pain, headache, dizziness, loss of consciousness, syncope, coma, taste perversion, pruritus, alopecia, cold intolerance, and paresthesia including feeling cold and chills.

Rare events of tracheal or tracheobronchial calcification have been reported in association with long-term warfarin therapy. The clinical significance of this event is unknown.

Priapism has been associated with anticoagulant administration: however, a causal relationship has not been established.

REPORTS OF SUSPECTED JANTOVEN SIDE EFFECTS / ADVERSE REACTIONS

Possible Jantoven side effects / adverse reactions in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-13

Patient: 21 year old male

Reactions: Drug Interaction, Ear Infection, Status Epilepticus, Anticonvulsant Drug Level Below Therapeutic

Adverse event resulted in: hospitalization

Suspect drug(s):
Rocephin
    Dosage: parenteral
    Indication: Ear Infection
    Start date: 2011-09-22
    End date: 2011-09-26

Jantoven
    Dosage: 2.5 mg, qd-bid, oral
    Administration route: Oral
    Indication: Deep Vein Thrombosis
    Start date: 2011-09-01
    End date: 2011-09-25

Dilantin
    Dosage: oral
    Administration route: Oral
    Indication: Epilepsy

Possible Jantoven side effects / adverse reactions in 73 year old male

Reported by a consumer/non-health professional from United States on 2011-11-10

Patient: 73 year old male

Reactions: Drug Dose Omission, Dyspnoea, Dizziness Postural, Hypotension, Incorrect Dose Administered

Suspect drug(s):
Zestril
    Administration route: Oral
    Start date: 2011-03-04

Furosemide
    Indication: Blood Pressure
    End date: 2011-03-03

Jantoven
    Dosage: 5 mg qd on monday, tuesday 7.5 mg wednesday
    Administration route: Oral
    Indication: Thrombosis
    Start date: 2011-01-05

Zestril
    Administration route: Oral
    Indication: Blood Pressure
    End date: 2011-03-03

Verapamil
    Indication: Blood Pressure
    End date: 2011-03-03

Other drugs received by patient: Colostazol; Metoprolol

Possible Jantoven side effects / adverse reactions in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-09

Patient: 21 year old male

Reactions: Anticonvulsant Drug Level Decreased, Drug Interaction, Status Epilepticus

Adverse event resulted in: hospitalization

Suspect drug(s):
Rocephin
    Indication: Ear Infection
    Start date: 2011-09-22
    End date: 2011-09-26

Jantoven
    Indication: Deep Vein Thrombosis
    Start date: 2011-09-01
    End date: 2011-09-25

Dilantin
    Indication: Epilepsy

Other drugs received by patient: Lovenox