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Medication Guide — Ticlopidine Hydrochloride Apo 027

Patient-friendly FDA guidance and safety information.

Last updated · May 21, 2026Source: DailyMed ↗
Boxed Warning

Ticlopidine 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/mm ), and the neutrophil count was below 450/mm in 17 of these patients (0.8% of the total population). 3 3

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 in stroke patients, 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 Hematologic 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 must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, ticlopidine should be immediately discontinued.

The detection and treatment of ticlopidine-associated hematological adverse reactions are further described under WARNINGS.

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

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IMPORTANT INFORMATION ABOUT TICLOPIDINE HYDROCHLORIDE TABLETS USP

The information in this leaflet is intended to help you use ticlopidine hydrochloride tablets safely. Please read the leaflet carefully. Although it does not contain all the detailed medical information that is provided to your doctor, it provides facts about ticlopidine hydrochloride tablets that are important for you to know. If you still have questions after reading this leaflet or if you have questions at any time during your treatment with ticlopidine hydrochloride tablets, check with your doctor.

Why Ticlopidine Hydrochloride Tablets Were Prescribed by Your Doctor:

Stroke Patients: Ticlopidine hydrochloride tablets are recommended to help reduce your risk of having a stroke, but only for patients who have had a stroke or early stroke warning symptoms while on aspirin, or for those who have these symptoms but are intolerant or allergic to aspirin.

Stent Patients: Ticlopidine hydrochloride tablets are recommended with aspirin for up to 30 days in patients who have had a stent implanted in their coronary arteries to reduce the risk of blood clots forming inside the stent.

Ticlopidine hydrochloride tablets are not prescribed for those who can take aspirin to reduce the risk of stroke because ticlopidine hydrochloride tablets can cause life-threatening blood problems. Special Warning for Users of Ticlopidine Hydrochloride Tablets/Necessary Blood Tests: Getting your blood tests done and reporting symptoms to your doctor as soon as possible can avoid serious complications.

The white cells of the blood that fight infection may drop to dangerous levels (a condition called neutropenia). This occurs in about 2.4% (1 in 40) of people on ticlopidine. You should be on the lookout for signs of infection such as fever, chills or sore throat. If this problem is caught early, it can almost always be reversed, but if undetected it can be fatal.

Another problem that has occurred in some patients taking ticlopidine is a decrease in cells called platelets (a condition called thrombocytopenia). This may occur as part of a syndrome that includes injury to red blood cells, causing anemia, kidney abnormalities, neurologic changes and fever. This condition is called TTP and can be fatal.

Things you should watch for as possible early signs of TTP are yellow skin or eye color, pinpoint dots (rash) on the skin, pale color, fever, weakness on a side of the body, or dark urine. If any of these occur, contact your doctor immediately.

Both complications occur most frequently in the first 90 days after ticlopidine hydrochloride tablets are started. To make sure you don’t develop either of these problems, If detected, neutropenia and thrombocytopenia can almost always be reversed. It is that you keep your appointments for the blood tests and that you call your doctor immediately if you have any indication that you may have TTP or neutropenia. If you stop taking ticlopidine hydrochloride tablets for any reason within the first 3 months, you will still need to have your blood tested for an additional 2 weeks after you have stopped taking ticlopidine hydrochloride tablets. your doctor will arrange for you to have your blood tested before you start taking ticlopidine hydrochloride tablets and then every 2 weeks for the first 3 months you are on ticlopidine hydrochloride tablets. essential

Rarely, decreases in the white blood cells, red blood cells and platelets can occur together. This condition is called aplastic anemia and can be fatal.

Things you should watch for as possible early signs of aplastic anemia are feeling of excessive weakness and tiredness, paleness, bruising, and bleeding from areas such as your nose or gums. You may also develop signs of infection such as fever. If any of these occur, contact your doctor immediately.

A few people may develop jaundice while being treated with ticlopidine hydrochloride tablets. The signs of jaundice are yellowing of the skin or the whites of the eyes or consistent darkening of the urine or lightening in the color of the stools. These symptoms should be reported to your physician promptly. Other Warnings and Precautions:

If any of the symptoms described above for neutropenia, TTP, aplastic anemia or jaundice occur, contact your doctor immediately.

Ticlopidine hydrochloride tablets should be used only as directed by your doctor. Do not give ticlopidine hydrochloride tablets to anyone else. Keep ticlopidine hydrochloride tablets out of reach of children!

Some people may have such side effects as diarrhea, skin rash, stomach or intestinal discomfort. If any of these problems are persistent, or if you are concerned about them, bring them to your doctor’s attention.

It may take longer than usual to stop bleeding when taking ticlopidine hydrochloride tablets. Tell your doctor if you have any more bleeding or bruising than usual, and, if you have emergency surgery, be sure to let your doctor or dentist know that you are taking ticlopidine hydrochloride tablets. Also, tell your doctor well in advance of any planned surgery (including tooth extraction), because he or she may recommend that you stop taking ticlopidine hydrochloride tablets temporarily.

How Ticlopidine Hydrochloride Tablets Work:

Stroke Patients: A stroke occurs when a clot (or thrombus) forms in a blood vessel in the brain or forms in another part of the body and breaks off, then travels to the brain (an embolus). In both cases the blood supply to part of the brain is blocked and that part of the brain is damaged. Ticlopidine hydrochloride tablets work by making the blood less likely to clot, although not so much less that it causes you to become likely to bleed, unless you have a bleeding disorder or some injury (such as a bleeding ulcer of the stomach or intestine) that is especially likely to bleed.

Stent Patients: A heart attack or angina (chest pain) can occur when fatty deposits block the arteries that carry oxygen and nutrient-rich blood to your heart. To decrease the chance of fatty deposits building up over time, your doctor may recommend the placement of a coronary stent. Ticlopidine hydrochloride tablets may be given to you with aspirin to make blood clots less likely to form inside the stent so that the artery remains open.

Who Should Not Take Ticlopidine Hydrochloride Tablets? Contact your doctor immediately and do not take ticlopidine hydrochloride tablets if:

  • you have an allergic reaction to ticlopidine hydrochloride tablets
  • you have a blood disorder or a serious bleeding problem, such as a bleeding stomach ulcer
  • you have previously been told you had TTP or aplastic anemia
  • you have severe liver disease or other liver problems
  • you are pregnant or you are planning to become pregnant
  • you are breast-feeding

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. H 2/2012

Sources

RxCUI: 313406

NDC: 605050027

Last fetched: May 21, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.