Ticlid

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some of the side effects of ticlopidine can occur in the first few days of taking this medicine, or after several weeks of treatment.

Call your doctor at once if you have:

• any bleeding that will not stop;
• severe or ongoing diarrhea;
• pink or brown urine;
• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of a serious blood-clotting problem--pale skin, purple spots under your skin or on your mouth, problems with speech, weakness, seizures (convulsions), dark urine, jaundice.

Common side effects may include:

• low blood cell counts;
• diarrhea, nausea, vomiting;
• upset stomach; or
• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ticlid (Ticlopidine Hcl)

Ticlid Professional Information

SIDE EFFECTS

Adverse reactions in stroke patients were relatively frequent with over 50% of patients reporting at least one. Most (30% to 40%) involved the gastrointestinal tract. Most adverse effects are mild, but 21% of patients discontinued therapy because of an adverse event, principally diarrhea, rash, nausea, vomiting, GI pain and neutropenia. Most adverse effects occur early in the course of treatment, but a new onset of adverse effects can occur after several months.

The incidence rates of adverse events listed in the following table were derived from multicenter, controlled clinical trials in stroke patients described above comparing TICLID (ticlopidine hcl) , placebo and aspirin over study periods of up to 5.8 years. Adverse events considered by the investigator to be probably drug-related that occurred in at least 1% of patients treated with TICLID (ticlopidine hcl) are shown in the following table:

Percent of Patients With Adverse Events in Controlled Studies (TASS and CATS)

Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.

Hematological: Neutropenia/thrombocytopenia, TTP, aplastic anemia (see BOXED WARNING and WARNINGS), leukemia, agranulocytosis, eosinophilia, pancytopenia, thrombocytosis and bone-marrow depression have been reported.

Gastrointestinal: TICLID (ticlopidine hcl) therapy has been associated with a variety of gastrointestinal complaints including diarrhea and nausea. The majority of cases are mild, but about 13% of patients discontinued therapy because of these. They usually occur within 3 months of initiation of therapy and typically are resolved within 1 to 2 weeks without discontinuation of therapy. If the effect is severe or persistent, therapy should be discontinued. In some cases of severe or bloody diarrhea, colitis was later diagnosed.

Hemorrhagic: TICLID (ticlopidine hcl) has been associated with increased bleeding, spontaneous posttraumatic bleeding and perioperative bleeding including, but not limited to, gastrointestinal bleeding. It has also been associated with a number of bleeding complications such as ecchymosis, epistaxis, hematuria and conjunctival hemorrhage.

Intracerebral bleeding was rare in clinical trials in stroke patients with TICLID (ticlopidine hcl) , with an incidence no greater than that seen with comparator agents (ticlopidine 0.5%, aspirin 0.6%, placebo 0.75%). It has also been reported postmarketing.

Rash: Ticlopidine has been associated with a maculopapular or urticarial rash (often with pruritus). Rash usually occurs within 3 months of initiation of therapy with a mean onset time of 11 days. If drug is discontinued, recovery occurs within several days. Many rashes do not recur on drug rechallenge. There have been rare reports of severe rashes, including Stevens-Johnson syndrome, erythema multiforme and exfoliative dermatitis.

Less Frequent Adverse Reactions (Probably Related): Clinical adverse experiences occurring in 0.5% to 1.0% of stroke patients in controlled trials include: Digestive System: GI fullness

Skin and Appendages: urticaria

Nervous System: headache

Body as a Whole: asthenia, pain

Hemostatic System: epistaxis

Special Senses: tinnitus

In addition, rarer, relatively serious and potentially fatal events associated with the use of TICLID (ticlopidine hcl) have also been reported from postmarketing experience: Hemolytic anemia with reticulocytosis, immune thrombocytopenia, hepatitis, hepatocellular jaundice, cholestatic jaundice, hepatic necrosis, hepatic failure, peptic ulcer, renal failure, nephrotic syndrome, hyponatremia, vasculitis, sepsis, allergic reactions (including angioedema, allergic pneumonitis, and anaphylaxis), systemic lupus (positive ANA), peripheral neuropathy, serum sickness, arthropathy and myositis.

Read the entire FDA prescribing information for Ticlid (Ticlopidine Hcl)

&Copy; Ticlid Patient Information is supplied by Cerner Multum, Inc. and Ticlid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.