Serious side effects have been reported with ticlopidine. See the “Drug Precautions” section.
Common side effects of ticlopidine include the following:
- nausea
- diarrhea
- upset stomach
- rash
- stomach pain
- purple-colored spots and patches that form on the skin
- vomiting
- gas
- itching
- loss of weight due to loss of appetite
- dizziness
This is not a complete list of ticlopidine side effects. Ask your doctor or pharmacist for more information.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Ticlopidine is a prescription medication used to reduce the risk of stroke in people who have had a stroke or have had warning signs of a stroke. Ticlopidine is also used along with aspirin to prevent blood clots from forming in stents placed in the heart. Ticlopidine belongs to a class of drugs called antiplatelets. These work by preventing platelets (a type of blood cell) from collecting and forming clots.
This medication comes in tablet form and is typically taken 2 times a day with food.
Common side effects of ticlopidine include nausea, diarrhea, upset stomach, rash, and stomach pain.
Ticlopidine hydrochloride can cause life-threatening hematological adverse reactions, including neutropenia/agranulocytosis, thrombotic thrombocytopenic purpura (TTP) and aplastic anemia.
Neutropenia/Agranulocytosis
Among 2048 patients in clinical trials in stroke patients, there were 50 cases (2.4%) of neutropenia (less than 1200 neutrophils/mm3), and the neutrophil count was below 450/mm3 in 17 of these patients (0.8% of the total population).
TTP
One case of thrombotic thrombocytopenic purpura was reported during clinical trials in stroke patients. Based on postmarketing data, US physicians reported about 100 cases between 1992 and 1997. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine-associated TTP may be as high as one case in every 2000 to 4000 patients exposed.
Aplastic Anemia
Aplastic anemia was not seen during clinical trials, but US physicians reported about 50 cases between 1992 and 1998. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine-associated aplastic anemia may be as high as one case in every 4000 to 8000 patients exposed.
Monitoring of Clinical and Hematological Status
Severe hematological adverse reactions may occur within a few days of the start of therapy. The incidence of TTP peaks after about 3 to 4 weeks of therapy and neutropenia peaks at approximately 4 to 6 weeks. The incidence of aplastic anemia peaks after about 4 to 8 weeks of therapy. The incidence of the hematologic adverse reactions declines thereafter. Only a few cases of neutropenia, TTP, or aplastic anemia have arisen after more than 3 months of therapy.
Hematological adverse reactions cannot be reliably predicted by any identified demographic or clinical characteristics. During the first 3 months of treatment, patients receiving ticlopidine hydrochloride must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, ticlopidine hydrochloride should be immediately discontinued.