Jantoven (Warfarin Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The following serious adverse reactions to JANTOVEN are discussed in greater detail in other sections of the labeling:

• Hemorrhage [see Boxed Warning, Warnings and Precautions (5.1) , and Overdosage (10) ]
• Necrosis of skin and other tissues [see Warnings and Precautions (5.2) ]
• Systemic atheroemboli and cholesterol microemboli [see Warnings and Precautions (5.3) ]

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

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