Cognex Side Effects

Generic name: tacrine

Note: This document contains side effect information about tacrine. Some of the dosage forms listed on this page may not apply to the brand name Cognex.

Some side effects of Cognex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tacrine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking tacrine (the active ingredient contained in Cognex) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• confusion, hallucinations;

• extreme or sudden changes in behavior;

• seizure (convulsions);

• pain or burning when you urinate; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of tacrine include:

• mild nausea, vomiting, diarrhea, upset stomach;

• weight loss;

• urinating more than usual;

• agitation, depressed mood;

• skin rash, increased sweating;

• fever or chills, runny nose, cough;

• dizziness, drowsiness, tired feeling;

• joint or muscle pain; or

• weakness, lack of coordination.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to tacrine: oral capsule

Hepatic

Elevations in LFTs (liver function tests) have been reported in as many as 50% of patients started on tacrine (the active ingredient contained in Cognex) therapy. LFTs should be closely monitored while patients are treated with tacrine, particularly when therapy is initiated and when dosages are altered.

Specific recommendations for LFT monitoring are as follows:

Every-other-week monitoring of LFTs, particularly ALT, is recommended during the first sixteen weeks of tacrine therapy.

If modest elevations of up to two times the ULN (upper limit of normal) occur, continued every-other-week LFTs are recommended.

If elevations of up to three times ULN occur, weekly LFT monitoring is recommended until LFTs return to normal.

If elevations of up to five times ULN occur, a daily dosage reduction of 40 mg and weekly LFT monitoring is recommended until LFTs return to normal.

If elevations greater than five times ULN occur, discontinuation of tacrine therapy is recommended until LFTs return to normal.

Rechallenge may be attempted in patients who have discontinued tacrine therapy as a result of elevated LFTs (but rechallenge is contraindicated in patients with a history tacrine-induced jaundice). Rechallenge should only proceed once LFTs have returned to normal. A daily dose of 40 mg may be attempted. LFTs should be monitored weekly during rechallenge. Limited experience is available concerning rechallenge in patients with a history of tacrine-induced LFT elevations greater than 10 times ULN.

Twenty-five percent of patients may experience a rise in ALT to three times normal. Seven percent may experience a rise in ALT to 10 times normal. Large rises in LFTs have been associated with hepatocellular injury rarely. Pathologic findings associated with tacrine-induced hepatotoxicity include granulomatous changes and hepatocellular necrosis.

Other

Cholinergic adverse effects occur in as many as 68% of treated patients and include nausea, vomiting, diarrhea, dyspepsia, anorexia, restlessness, tremors, myalgia, arthralgia, excessive sweating, rash and frequent micturition. Hypotension, hypertension, bradycardia, syncope, ataxia and confusion have also been reported less frequently.

The cholinomimetic effects of tacrine may result in an increase in gastric acid secretion and may therefore increase the risk of gastric ulceration in some patients.

Because of the potential vagotonic effects of cholinomimetic therapy, use in patients with "sick sinus syndrome" should be undertaken, if at all, with caution.

Hematologic

Agranulocytosis has been reported in four of 8000 treated patients. Three of the four patients had medical conditions associated with agranulocytosis.

Nervous system

A case of exacerbation of parkinsonism has been reported. Some clinicians have also reported vertigo and paresthesias as nervous system effects. Six cases of generalized tonic or tonic-clonic seizures have also been reported.

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