Cilostazol Side Effects

In Summary

Commonly reported side effects of cilostazol include: infection, dizziness, headache, palpitations, diarrhea, pharyngitis, and change in stool. Other side effects include: tachycardia, abdominal pain, rhinitis, and peripheral edema. See below for a comprehensive list of adverse effects.

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.

Major Side Effects

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

• Fast or irregular heartbeat
• fever

• Abnormal bleeding
• bloody or black tarry stools
• bruises or red spots on the skin
• fainting
• nausea, heartburn, 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

• Abdominal or stomach pain
• area rash
• bleeding gums
• bleeding tendency
• blistering, peeling, loosening of the skin
• blood in the urine or stools
• blurred vision
• chest pain
• chills
• clay-colored stools
• confusion
• cough or hoarseness
• coughing up blood
• dark urine
• diarrhea
• difficulty with breathing
• drowsiness
• fever with or without chills
• general feeling of tiredness or weakness
• headache, sudden and severe
• inability to speak
• itching of the eyes
• itching of the skin
• joint or muscle pain
• 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 the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• skin rash
• slurred speech
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• swollen glands
• temporary blindness
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in the arm or leg on one side of the body, sudden and severe
• weakness of part of the body
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking cilostazol, get emergency help immediately:

• Diarrhea
• dizziness or lightheadedness when getting up from a lying or sitting position
• fast or irregular heartbeat
• headache (severe)

Minor Side Effects

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:

• Back pain
• dizziness
• gas
• headache
• increased cough
• pain or stiffness in the muscles
• pounding heartbeat
• runny or stuffy nose
• sore throat
• swelling of the arms or legs

• Bone pain
• burning feeling in the throat or chest
• difficulty with swallowing
• hives
• pain or stiffness in the joints
• ringing or buzzing in the ears
• swelling of the face, fingers, or lower legs

• Bruising
• hot flushes
• pain

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]

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.

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