Cilostazol Side Effects

Not all side effects for cilostazol 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 cilostazol: oral tablet

In addition to its needed effects, some unwanted effects may be caused by cilostazol. 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 cilostazol:

More common
  • Fast or irregular heartbeat
  • fever
Less common
  • Abnormal bleeding
  • bloody or black tarry stools
  • bruises and/or red spots on the skin
  • fainting
  • nausea, heartburn, and/or indigestion (severe or continuing)
  • nosebleeds
  • stiff neck
  • stomach pain, cramping, or burning (severe)
  • swelling of the tongue
  • vomiting of blood or material that looks like coffee grounds
Incidence not known
  • Abdominal or stomach pain
  • area rash
  • bleeding gums
  • bleeding tendency
  • blistering, peeling, loosening of skin
  • blood in urine or stools
  • blurred vision
  • chest pain
  • chills
  • clay-colored stools
  • confusion
  • cough or hoarseness
  • coughing up blood
  • dark urine
  • diarrhea
  • difficult breathing
  • drowsiness
  • fever with or without chills
  • general feeling of tiredness or weakness
  • headache, sudden and severe
  • inability to speak
  • irregular heartbeat
  • itching of eyes
  • itching of skin
  • joint or muscle pain
  • lab results that show problems with the liver
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • lower back or side pain
  • nausea and vomiting
  • painful or difficult urination
  • pinpoint red spots on skin
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • seizures
  • shortness of breath
  • skin rash
  • slurred speech
  • sores, ulcers, or white spots on lips or in mouth
  • stomach pain
  • swollen glands
  • temporary blindness
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in arm and/or leg on one side of the body, sudden and severe
  • weakness of part of body
  • wheezing
  • yellow eyes or skin
Symptoms of overdose
  • Diarrhea
  • dizziness or lightheadedness when getting up from a lying or sitting position
  • fast or irregular heartbeat
  • headache (severe)

Some of the side effects that can occur with cilostazol 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:

More commonLess common
  • Bone pain
  • burning feeling in throat or chest
  • difficulty in swallowing
  • hives
  • pain or stiffness in joints
  • ringing or buzzing in ears
  • swelling of face, fingers, and/or lower legs
Incidence not known
  • Bruising
  • hot flushes
  • pain
  • Back pain
  • dizziness
  • gas
  • headache
  • increased cough
  • pain or stiffness in muscles
  • pounding heartbeat
  • runny or stuffy nose
  • sore throat
  • swelling of arms or legs

For Healthcare Professionals

Applies to cilostazol: oral tablet

Nervous system

Nervous system side effects have commonly included headache (34%) resulting in discontinuation in 3.5% of patients. Dizziness (10%) and vertigo (2%) have also been reported. Other less frequently reported side effects have included asthenia, hyperesthesia, and paresthesia. Postmarketing reports have included intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident, extradural hematoma and subdural hematoma.[Ref]

Cardiovascular

An increase in ventricular premature beats and nonsustained ventricular tachycardia have been seen in Holter monitored patients. Cardiovascular damage including endocardial hemorrhage, left ventricular fibrosis, and necrosis of smooth muscle in coronary arteries has been demonstrated in dogs after 52 weeks of cilostazol administration.

In the AT-BAT study, one patient died during a bradycardic episode 46 hours after a successful PCI, another patient required surgical revascularization, and one patient experienced no reflow requiring a temporary intra-aortic balloon.[Ref]

Cardiovascular side effects have included palpitations (10%) and tachycardia (4%). Peripheral edema has been reported in 7% of patients, and hypertension and angina pectoris have been reported in 2% of patients. Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, hemorrhage, hypotension, myocardial infarction, myocardial ischemia, nodal arrhythmia, postural hypotension, supraventricular tachycardia, syncope, varicose vein, vasodilation, ventricular extrasystoles, and ventricular tachycardia have also been reported. Post marketing reports have included torsades de pointes and QTc prolongation in patients with cardiac disorders, e.g. complete atrioventricular block, cardiac failure and bradyarrhythmia. In these reports cilostazol was used "off label" due to its positive chronotropic action.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea (19%), nausea (7%), dyspepsia (6%), abdominal pain (5%), flatulence (3%) and vomiting (2%). Other gastrointestinal side effects have included anorexia, cholelithiasis, colitis, duodenal ulcer, duodenitis, esophageal hemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum hemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal hemorrhage, stomach ulcer, and tongue edema.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain (7%), myalgia (3%), leg cramps (2%), and arthritis (2%).[Ref]

Respiratory

Respiratory side effects have included pharyngitis (10%), rhinitis (7%), increased cough (4%), dyspnea (2%), and bronchitis (2%). Postmarketing reports have included pulmonary hemorrhage and interstitial pneumonia.[Ref]

Dermatologic

Dermatologic side effects have included rash in 2% of patients. Postmarketing reports have included pruritus and skin eruptions including Stevens-Johnson syndrome.[Ref]

Hematologic

In the AT-BAT study, one patient who did not undergo PCI had major bleeding during CABG on the day following angiography, nine patients had minor bleeding (mostly due to access site bleeding), and two patients developed moderate thrombocytopenia.[Ref]

Hematologic side effects have included postmarketing reports of thrombocytopenia, aplastic anemia, leukopenia, and bleeding tendencies.[Ref]

Hepatic

Hepatic side effects have included postmarketing reports of jaundice, hepatic dysfunction and abnormal liver function tests.[Ref]

Renal

Renal side effects have included postmarketing reports of increased BUN and hematuria.[Ref]

References

1. Pratt CM "Analysis of the cilostazol safety database." Am J Cardiol 87 (2001): d28-33

2. Ohashi S, Iwatani Y, Hyakuna Y, Morioka Y "Thermographic evaluation of the hemodynamic effect of the antithrombotic cilostazol in peripheral arterial occclusion." Arzneimittelforschung 35 (1985): 1203-8

3. Atarashi H, Endoh Y, Saitoh H, Kishida H, Hayakawa H "Chronotropic effects of cilostazol, a new antithrombotic agent, in patients with bradyarrhythmias." J Cardiovasc Pharmacol 31 (1998): 534-9

4. "Product Information. Pletal (cilostazol)." Otsuka American Pharmaceuticals, Rockville, MD.

5. Niki T, Mori H "Phase I study of cilostazol. Safety evaluation at increasing single doses in healthy volunteers." Arzneimittelforschung 35 (1985): 1173-85

6. Money SR, Herd JA, Isaacsohn JL, Davidson M, Cutler B, Heckman J, Forbes WP "Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease." J Vasc Surg 27 (1998): 267-74;disc. 274-5

7. Sekiya M, Funada J, Watanabe K, Miyagawa M, Akutsu H "Effects of probucol and cilostazol alone and in combination on frequency of poststenting restenosis." Am J Cardiol 82 (1998): 144-7

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