Jantoven Side Effects

Generic Name: warfarin

Note: This page contains information about the side effects of warfarin. Some of the dosage forms included on this document may not apply to the brand name Jantoven.

Not all side effects for Jantoven may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to warfarin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by warfarin (the active ingredient contained in Jantoven). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking warfarin:

Less common
  • Abdominal or stomach pain with cramping
  • bleeding gums
  • blood in the urine
  • bloody stools
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • confusion
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • excessive bruising
  • headache
  • increased menstrual flow or vaginal bleeding
  • nosebleeds
  • paralysis
  • peeling of the skin
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • shortness of breath
  • sweating
  • unexplained swelling
  • unusual tiredness or weakness
Rare
  • Arm, back, or jaw pain
  • blue-green to black skin discoloration
  • blue or purple toes
  • change in consciousness
  • chest tightness or heaviness
  • chills
  • clay-colored stools
  • diarrhea
  • dizziness
  • fainting or loss of consciousness
  • fast or irregular breathing
  • fast or irregular heartbeat
  • fever
  • itching
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • pain in the toes
  • pain, redness, or sloughing of the skin
  • pale skin
  • skin blisters
  • skin rash
  • small red or purple spots on the skin
  • stomach pain
  • swelling of the eyes or eyelids
  • tightness in the chest or wheezing
  • troubled breathing with exertion
  • unpleasant breath odor
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • vomiting of blood
  • yellow eyes and skin
Incidence not known
  • Painful or prolonged erection of the penis

Some of the side effects that can occur with warfarin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Joint pain
  • muscle pain
Rare
  • Bloated
  • change in taste, or bad, unusual, or unpleasant (after) taste
  • cold intolerance
  • excess air or gas in the stomach or intestines
  • full feeling
  • general feeling of discomfort or illness
  • hair loss or thinning of the hair
  • hives or welts
  • lack or loss of strength
  • pain
  • passing gas
  • red, sore, or itching skin
  • sores, welting, or blisters
  • unusual drowsiness, dullness, or feeling of sluggishness

For Healthcare Professionals

Applies to warfarin: compounding powder, intravenous powder for injection, oral tablet

Hematologic

Hematologic side effects including occult and overt bleeding or hemorrhage at any site have been reported the most frequently. Bleeding complications may present as paralysis, paresthesia, headache, chest, abdominal, joint, muscle or other pain, dizziness, shortness of breath, difficulty breathing or swallowing, unexplained swelling, weakness, hypotension, or unexplained shock. Bleeding may result in hematomas, melena, hematuria, ecchymoses, epistaxis, and hematemesis. Spontaneous intraspinal hematomas, spinal cord hemorrhage, gastrointestinal hemorrhage, intracranial hemorrhage, ocular hemorrhage, intra-abdominal hemorrhage, hemopericardium, compartment syndrome following blunt trauma, and other serious bleeding events have been reported. Anemia has been reported infrequently.

Warfarin-induced intracranial hemorrhage is associated with a high rate of mortality and disability compared with extracranial hemorrhages.[Ref]

Hematologic risk factors have included history of stroke, a serious comorbid condition, a history of gastrointestinal bleeding, atrial fibrillation, advanced age, and concomitant use of aspirin. In addition, patients with genetic variations in the CYP450 2C9 and VKORC1 enzymes are at a higher risk of bleeding than those without the variation.

A meta-analysis of five randomized controlled trials compared the efficacy and safety of combined oral anticoagulation and antiplatelet therapy versus oral anticoagulants alone after prosthetic heart valve replacement and found an increased risk of general hemorrhage (65%) and gastrointestinal hemorrhage (250%). Embolism and stroke were significantly decreased. The authors conclude that the benefits of decreased risk of thromboembolic events outweigh the toxic effects of combined anticoagulation and antiplatelet therapy.

The results of large observational cohort study (n=13,559) indicate that in patients with nonvalvular atrial fibrillation, the risk of major hemorrhage increases with age, particularly intracranial hemorrhage, whether or not they are receiving warfarin. In patients aged 80 and older the risk of intracranial hemorrhage increases sharply. Also, this study found that among anticoagulated patients with atrial fibrillation, intracranial hemorrhages were responsible for nearly 90% of the deaths from warfarin-associated hemorrhage and the majority of disability among survivors.[Ref]

Dermatologic

Warfarin-induced skin necrosis predominantly affects obese women (4-fold greater occurrence in women) and typically occurs within 10 days of the initiation of therapy, but has occurred after several months or several years of therapy. The majority of lesions (80%) occur in areas with abundant adipose such as the thighs, breasts, abdomen, buttocks, and the extremities. The lesions are usually painful, abrupt in onset, erythematous, purpuric, and sharply demarcated. The proposed mechanism of warfarin-induced skin necrosis involves an imbalance between protein C or protein S and vitamin K-dependent clotting factors. The lesions may resolve spontaneously or progress to form hemorrhagic bullae with subsequent necrosis. Generally, warfarin (the active ingredient contained in Jantoven) is withheld; however, discontinuation does not affect lesion progression. Some patients have safely resumed warfarin therapy, but the recommended management in patients who require long-term anticoagulation is resumption of warfarin at a lower dose in conjunction with heparin bridge therapy. The dosage of warfarin should be slowly titrated until a therapeutic INR is reached.

One case of warfarin-induced skin necrosis of the eyelids has been reported. In this case, the patient developed bilateral periorbital ecchymoses with full-thickness necrotic lesions in the medial canthal region.[Ref]

Dermatologic side effects including necrosis of the skin and other tissues have been reported in 0.1% to 1.0% of patients. Dermatitis, urticaria, alopecia, rash, bullous eruptions, pruritus, and pallor have been reported infrequently.[Ref]

Other

Other side effects have been reported infrequently. These have included purple toe syndrome.[Ref]

Cardiovascular

Cardiovascular side effects have included systemic atheroemboli and cholesterol microemboli, which present with a variety of signs and symptoms. These have included purple toe syndrome, livedo reticularis (blue tingeing of the skin), rash, gangrene, abrupt and intense pain in the leg, foot, or toes, foot ulcers, myalgia, penile gangrene, abdominal pain, flank or back pain, hematuria, renal insufficiency, hypertension, cerebral ischemia, spinal cord infarction, pancreatitis, symptoms simulating polyarteritis, or any other sequelae of vascular compromise due to embolic occlusion. Hemopericardium and cardiac tamponade have also been reported. Hypotension, edema, angina syndrome, and chest pain have been reported infrequently.[Ref]

Hepatic

Hepatic side effects have been reported infrequently. These have included jaundice, intrahepatic cholestasis, hepatitis, and elevated liver enzymes.[Ref]

Renal

Renal side effects have been reported infrequently. These have included hematuria, acute renal failure due to interstitial nephritis, and renal hematomas.[Ref]

Gastrointestinal

A meta-analysis of five randomized controlled trials compared the efficacy and safety of combined oral anticoagulation and antiplatelet therapy versus oral anticoagulants alone after prosthetic heart valve replacement and found an increased risk of general hemorrhage (65%) and gastrointestinal hemorrhage (250%). Embolism and stroke were significantly decreased. The authors conclude that the benefits of decreased risk of thromboembolic events outweigh the toxic effects of combined anticoagulation and antiplatelet therapy.[Ref]

Gastrointestinal side effects have been reported infrequently. Nausea, diarrhea, abdominal cramping, vomiting, and flatulence/bloating have been reported. Gastrointestinal bleed has occurred when warfarin was combined with aspirin for antithrombotic effects after placement of heart valves.[Ref]

Genitourinary

Warfarin-induced priapism has been reported. In one case report, a 16 year old male patient had been treated with warfarin (the active ingredient contained in Jantoven) for a deep venous thrombosis in his leg. The patient experienced a hypercoagulable state upon initiation of warfarin therapy because he also had an undocumented protein C deficiency. This led to an increased risk of thromboembolism that manifested as priapism and skin necrosis.[Ref]

Genitourinary side effects have included priapism.[Ref]

Hypersensitivity

Hypersensitivity reactions including anaphylactic reactions have been reported infrequently. A case of leukocytoclastic cutaneous vasculitis has been reported.[Ref]

Nervous system

Nervous system side effects have been reported rarely. These have included fever, fatigue, lethargy, malaise, asthenia, pain, headache, dizziness, taste perversion, cold intolerance, and paresthesia including feeling cold and chills, syncope, loss of consciousness, and coma.

Respiratory

Respiratory side effects have been reported rarely. These have included tracheal or tracheobronchial calcification.

Ocular

Ocular side effects have included subconjunctival hemorrhage and retinal hemorrhage.[Ref]

References

1. Beyth RJ, Quinn LM, Landefeld CS "Prospective evaluation of an index for predicting the risk of major bleeding in outpatients treated with warfarin." Am J Med 105 (1998): 91-9

2. Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, Dangelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devote G, Berrettini M, "Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT)." Lancet 348 (1996): 423-8

3. Zimbelman J, Lefkowitz J, Schaeffer C, Hays T, MancoJohnson M, Manhalter C, Nuss R "Unusual complications of warfarin therapy: Skin necrosis and priapism." J Pediat 137 (2000): 266-8

4. Anand SS, Yusuf S "Oral anticoagulant therapy in patients with coronary artery disease: a meta-analysis." JAMA 282 (1999): 2058-67

5. Kabir A, Nadasdy T, Nadasdy G, Hebert LA "An unusual cause of gross hematuria and transient ARF in an SLE patient with warfarin coagulopathy." Am J Kidney Dis 43 (2004): 757-60

6. Bloch A, Ben-Chetrit E, Muszkat M, Caraco Y "Major bleeding caused by warfarin in a genetically susceptible patient." Pharmacotherapy 22 (2002): 97-101

7. Lederle FA, Cundy KV, Farinha P, Mccormick DP "Spinal epidural hematoma associated with warfarin therapy." Am J Med 100 (1996): 237-8

8. Reardon M, Burns B, Brewer B, Osullivan JP "Deaths associated with warfarin in elderly patients." Br J Clin Pract 49 (1995): 322-3

9. Fang MC, Go AS, Chang Y, et al. "Death and disability from warfarin-associated intracranial and extracranial hemorrhages." Am J Med 120 (2007): 700-5

10. Ageno W, Turpie AGG "Exaggerated initial response to warfarin following heart valve replacement." Am J Cardiol 84 (1999): 905-8

11. Landfeld CS, Goldman L "Major bleeding in outpatients treated with warfarin: incidence and prediction by factors known at the start of outpatient therapy." Am J Med 87 (1989): 144-52

12. Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, Turpie AG, Green D, Ginsberg JS, Wells P, MacKinnon B, Julian J "A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism." N Engl J Med 340 (1999): 901-7

13. Brigden ML "When bleeding complicates oral anticoagulant therapy: how to anticipate, investigate, and treat." Postgrad Med 98 (1995): 153

14. Fang MC, Go AS, Hylek EM, et al. "Age and the risk of warfarin-associated hemorrhage: the anticoagulation and risk factors in atrial fibrillation study." J Am Geriatr Soc 54 (2006): 1231-6

15. Jimenez J "Abdominal pain in a patient using warfarin - Intramural haematoma of the small bowel in the setting of the warfarin anticoagulation." Postgrad Med J 75 (1999): 747-8

16. Williams D, Ponte CD "Warfarin-associated hypoprothrombinemia: an unusual presentation." Am J Health Syst Pharm 60 (2003): 274-8

17. Blackshear JL, Baker VS, Holland A, Litin SC, Ahlquist DA, Hart RG, Ellefson R, Koehler J "Fecal hemoglobin excretion in elderly patients with atrial fibrillation: combined aspirin and low-dose warfarin vs conventional warfarin therapy." Arch Intern Med 156 (1996): 658-60

18. Landefeld CS, Rosenblatt MW, Goldman L "Bleeding in outpatients treated with warfarin: relation to the prothrombin time and important remediable lesions." Am J Med 87 (1989): 153-9

19. Fihn SD, Callahan CM, Martin DC, McDonell MB, Henikoff JG, White RH "The risk for and severity of bleeding complications in elderly patients treated with warfarin." Ann Intern Med 124 (1996): 970-9

20. Witt DM, Patel R, Tillman DJ, Wilkinson DS "Vitamin K for warfarin-associated coagulopathy." Lancet 357 (2001): 718

21. Morgan RJ, Bristol JB "Unusual findings in a patient taking warfarin - Retroperitoneal haematoma." Postgrad Med J 75 (1999): 299-300

22. Levine MN, Hirsh J "Hemorrhagic complications of anticoagulant therapy." Semin Thromb Hemost 12 (1986): 39-57

23. White RH, McKittrick T, Takakuwa J, Callahan C, McDonell M, Fihn S "Management and prognosis of life-threatening bleeding during warfarin therapy." Arch Intern Med 156 (1996): 1197-201

24. Wagner JL, Dent LA "Epistaxis associated with elevation of INR in a patient switched to generic warfarin." Pharmacotherapy 20 (2000): 240-3

25. Bodack MI "A warfarin-induced subconjunctival hemorrhage." Optometry 78 (2007): 113-8

26. Jabr FI "Rectal sheath hematoma in an elderly woman after anticoagulation treatment." J Am Geriatr Soc 54 (2006): 871-2

27. Locht H, Lindstrom FD "Severe skin necrosis following warfarin therapy in a patient with protein C deficiency." J Intern Med 233 (1993): 287-9

28. Tamir A, Wolf R, Brenner S "Leukocytoclastic vasculitis - another coumarin-induced hemorrhagic reaction." Acta Derm Venereol 74 (1994): 138-9

29. Kandrotas RJ, Deterding J "Genital necrosis secondary to warfarin therapy." Pharmacotherapy 8 (1988): 351-4

30. Eby CS "Warfarin-induced skin necrosis." Hematol Oncol Clin North Am 7 (1993): 1291-300

31. Nagao T, Ibayashi S, Fujii K, Sugimori H, Sadoshima S, Fujishima M "Treatment of warfarin-induced hair loss with ubidecarenone." Lancet 346 (1995): 1104-5

32. Cole MS, Minifee PK, Wolma FJ "Coumarin necrosis: a review of the literature." Surgery 103 (1988): 271-7

33. "Product Information. Coumadin (warfarin)." DuPont Pharmaceuticals, Wilmington, DE.

34. Srinivasan AF, Rice L, Bartholomew JR, et al. "Warfarin-induced skin necrosis and venous limb gangrene in the setting of heparin-induced thrombocytopenia." Arch Intern Med 164 (2004): 66-70

35. Horn JR, Danziger LH, Davis RJ "Warfarin-induced skin necrosis: report of four cases." Am J Hosp Pharm 38 (1981): 1763-8

36. Ward CT, Chavalitanonda N "Atypical warfarin-induced skin necrosis." Pharmacotherapy 26 (2006): 1175-9

37. "Summaries for patients. Gangrene of the leg during warfarin treatment in a patient with cancer." Ann Intern Med 135(8 Pt 1) (2001): S-49

38. Colman RW, Rao AK, Rubin RN "Warfarin skin necrosis in a 33-year-old woman." Am J Hematol 43 (1993): 300-3

39. Stewart AJ, Penman ID, Cook MK, Ludlam CA "Warfarin-induced skin necrosis." Postgrad Med J 75 (1999): 233-5

40. Griffin JP "Anticoagulants and skin necrosis." Adverse Drug React Toxicol Rev 13 (1994): 157-67

41. Rafiei N, Tabandeh H, Hirschbein M "Warfarin-induced skin necrosis of the eyelids." Arch Ophthalmol 125 (2007): 421

42. LaPrade RF, Fowler BL, Ryan TG "Skin necrosis with minidose warfarin used for prophylaxis against thromboembolic disease after hip surgery." Orthopedics 16 (1993): 703-4

43. Humphries JE, Gardner JH, Connelly JE "Warfarin skin necrosis: recurrence in the absence of anticoagulant therapy." Am J Hematol 37 (1991): 197-200

44. O'Leary KJ, Horn K "Blue-tinged toes." Am J Med 118 (2005): 1105-7

45. Lee KS, Marwick T "Hemopericardium and cardiac tamponade associated with warfarin therapy." Cleve Clin J Med 60 (1993): 336-8

46. Adler E, Benjamin SB, Zimmerman HJ "Cholestatic hepatic injury related to warfarin exposure." Arch Intern Med 146 (1986): 1837-9

47. Jones DB, Makepeace MC, Smith PC "Jaundice following warfarin therapy." Postgrad Med J 56 (1980): 671

48. Volpi A, Ferrario GM, Giordano F, et al "Acute renal failure due to hypersensitivity interstitial nephritis induced by warfarin sodium." Nephron 52 (1989): 196

49. Dajani YF "Hematuria in patients on anticoagulants." N Engl J Med 297 (1977): 222

50. Klinger ME, Tanenbaum B, Elguezabal A "Pseudo-tumors of the kidney secondary to anticoagulant therapy." J Urol 106 (1971): 507-11

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)