Cognex Side Effects
Please note - some side effects for Cognex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Cognex - for the Consumer
Cognex
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cognex:
Seek medical attention right away if any of these SEVERE side effects occur when using Cognex:Constipation; diarrhea; gas; loss of appetite; muscle aches or pain; nausea; stomach upset; stuffy nose; vomiting; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; chest pain; dark urine; decreased coordination; decreased urination; fainting; fever; new or worsening mental or mood problems; pale stools; seizures; severe or persistent dizziness or headache; severe or persistent stomach pain; slow or irregular heartbeat; swelling of the hands, ankles, or feet; tremor; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopCognex Side Effects - for the Professional
Cognex
Common Adverse Events Leading to Discontinuation
In clinical trials, approximately 17% of the 2706 patients who received Cognex® and 5% of the 1886 patients who received placebo withdrew permanently because of adverse events. It should be noted that some of the placebo-treated patients were exposed to Cognex® prior to receiving placebo due to the variety of study designs used, including crossover studies. Transaminase elevations were the most common reason for withdrawals during Cognex® treatment (8% of all Cognex®-treated patients, or 212 of 456 patients withdrawn). The controlled clinical trial protocols required that any patient with an ALT/SGPT elevation >3 X ULN be withdrawn, because of concern about potential hepatotoxicity. Apart from withdrawals due to transaminase elevations, 244 patients (9%) withdrew for adverse events while receiving Cognex®.
Other adverse events that most frequently led to the withdrawal of tacrine-treated patients in clinical trials were nausea and/or vomiting (1.5%), agitation (0.9%), rash (0.7%), anorexia (0.7%), and confusion (0.5%). These adverse events also most frequently led to the withdrawal of placebo-treated patients, although at lower frequencies (0.1% to 0.2%).
Most Frequent Adverse Clinical Events Seen in Association With the Use of Tacrine
The events identified here are those that occurred at an absolute incidence of at least 5% of patients treated with Cognex®, and at a rate at least 2-fold higher in patients treated with Cognex®than placebo.
The most common adverse events associated with the use of Cognex® were elevated transaminases, nausea and/or vomiting, diarrhea, dyspepsia, myalgia, anorexia, and ataxia. Of these events, nausea and/or vomiting, diarrhea, dyspepsia, and anorexia appeared to be dose-dependent.
Adverse Events Reported in Controlled Trials
Adverse Events Reported in Controlled Trials
The events cited in the tables below reflect experience gained under closely monitored conditions of clinical trials with a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.
Table 3 lists treatment-emergent signs and symptoms that occurred in at least 2% of patients with Alzheimer's disease in placebo-controlled trials and who received the recommended regimen for dose introduction and titration of Cognex®.
Table 3. Adverse Events Occurring in at Least 2% of Patients Receiving Cognex®
at a Starting Dose of 40 mg/day with Titration in 40 mg/day Increments
Every 6 Weeks in Controlled Clinical Trials
[Number (%) of Patients]
| BODY SYSTEM/Adverse Events | Cognex®N = 634 | PlaceboN = 342 |
| LABORATORY DEVIATIONS | ||
| Elevated Transaminasea | 184 (29) | 5 (2) |
| BODY AS A WHOLE | ||
| Headache | 67 (11) | 52 (15) |
| Fatigue | 26 (4) | 9 (3) |
| Chest Pain | 24 (4) | 18 (5) |
| Weight Decrease | 21 (3) | 4 (1) |
| Back Pain | 15 (2) | 14 (4) |
| Asthenia | 15 (2) | 7 (2) |
| DIGESTIVE SYSTEM | ||
| Nausea and/or Vomiting | 178 (28) | 29 (9) |
| Diarrhea | 99 (16) | 18 (5) |
| Dyspepsia | 57 (9) | 22 (6) |
| Anorexia | 54 (9) | 11 (3) |
| Abdominal Pain | 48 (8) | 24 (7) |
| Flatulence | 22 (4) | 5 (2) |
| Constipation | 24 (4) | 8 (2) |
| HEMIC AND LYMPHATIC SYSTEM | ||
| Purpura | 15 (2) | 8 (2) |
| MUSCULOSKELETAL SYSTEM | ||
| Myalgia | 54 (9) | 18 (5) |
| NERVOUS SYSTEM | ||
| Dizziness | 73 (12) | 39 (11) |
| Confusion | 42 (7) | 24 (7) |
| Ataxia | 36 (6) | 12 (4) |
| Insomnia | 37 (6) | 18 (5) |
| Somnolence | 22 (4) | 11 (3) |
| Tremor | 14 (2) | 2 (<1) |
| PSYCHOBIOLOGIC FUNCTION | ||
| Agitation | 43 (7) | 30 (9) |
| Depression | 22 (4) | 14 (4) |
| Thinking Abnormal | 17 (3) | 14 (4) |
| Anxiety | 16 (3) | 7 (2) |
| Hallucination | 15 (2) | 12 (4) |
| Hostility | 15 (2) | 5 (2) |
| RESPIRATORY SYSTEM | ||
| Rhinitis | 51 (8) | 22 (6) |
| Upper Respiratory Infection | 18 (3) | 11 (3) |
| Coughing | 17 (3) | 18 (5) |
| SKIN AND APPENDAGES | ||
| Rashb | 46 (7) | 18 (5) |
| Facial Flushing, Skin Flushing | 16 (3) | 3 (<1) |
| UROGENITAL SYSTEM | ||
| Urination Frequency | 21 (3) | 12 (4) |
| Urinary Tract Infection | 21 (3) | 20 (6) |
| Urinary Incontinence | 16 (3) | 9 (3) |
a ALT or AST value of approximately 3 X ULN or greater or that resulted in a change in patient management. Patients were monitored weekly.
b Includes COSTART terms: rash, rash-erythematous, rash-maculopapular, urticaria, petechial rash, rash-vesiculobullous, and pruritus.
Other Adverse Events Observed During All Clinical Trials
Cognex® has been administered to 2706 individuals during clinical trials. A total of 1471 patients were treated for at least 3 months, 1137 for at least 6 months, and 773 for at least 1 year. Any untoward reactions that occurred during these trials were recorded as adverse events by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having similar types of events, the events were grouped into a smaller number of standardized categories using a modified COSTART dictionary. These categories are used in the listing below. The frequencies represent the proportion of the 2706 individuals exposed to Cognex® who experienced that event while receiving Cognex®. All adverse events are included except those already listed on the previous table and those COSTART terms too general to be informative. Events are further classified by body system categories and listed using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; and rare adverse events are those occurring in less than 1/1000 patients. These adverse events are not necessarily related to Cognex® treatment. Only rare adverse events deemed to be potentially important are included.
Frequent: Chill, fever, malaise, peripheral edema. Infrequent: Face edema, dehydration, weight increase, cachexia, edema (generalized), lipoma. Rare: Heat exhaustion, sepsis, cholingeric crisis, death.
Frequent: Hypotension, hypertension. Infrequent: Heart failure, myocardial infarction, angina pectoris, cerebrovascular accident, transient ischemic attack, phlebitis, venous insufficiency, abdominal aortic aneurysm, atrial fibrillation or flutter, palpitation, tachycardia, bradycardia, pulmonary embolus, migraine, hypercholesterolemia. Rare: Heart arrest, premature atrial contractions, A-V block, bundle branch block.
Infrequent: Glossitis, gingivitis, mouth or throat dry, stomatitis, increased salivation, dysphagia, esophagitis, gastritis, gastroenteritis, GI hemorrhage, stomach ulcer, hiatal hernia, hemorrhoids, stools bloody, diverticulitis, fecal impaction, fecal incontinence, hemorrhage (rectum), cholelithiasis, cholecystitis, increased appetite. Rare: Duodenal ulcer, bowel obstruction.
Infrequent: Diabetes. Rare: Hyperthyroid, hypothyroid.
Infrequent: Anemia, lymphadenopathy. Rare: Leukopenia, thrombocytopenia, hemolysis, pancytopenia.
Frequent: Fracture, arthralgia, arthritis, hypertonia. Infrequent: Osteoporosis, tendinitis, bursitis, gout. Rare: Myopathy.
Frequent: Convulsions, vertigo, syncope, hyperkinesia, paresthesia. Infrequent: Dreaming abnormal, dysarthria, aphasia, amnesia, wandering, twitching, hypesthesia, delirium, paralysis, bradykinesia, movement disorder, cogwheel rigidity, paresis, neuritis, hemiplegia, Parkinson's disease, neuropathy, extrapyramidal syndrome, reflexes decreased/absent. Rare: Tardive dyskinesia, dysesthesia, dystonia, encephalitis, coma, apraxia, oculogyric crisis, akathisia, oral facial dyskinesia, Bell's palsy, exacerbation of Parkinson's disease.
Frequent: Nervousness. Infrequent: Apathy, increased libido, paranoia, neurosis. Rare: Suicidal, psychosis, hysteria.
Frequent: Pharyngitis, sinusitis, bronchitis, pneumonia, dyspnea. Infrequent: Epistaxis, chest congestion, asthma, hyperventilation, lower respiratory infection. Rare: Hemoptysis, lung edema, lung cancer, acute epiglottitis.
Frequent: Sweating increased. Infrequent: Acne, alopecia, dermatitis, eczema, skin dry, herpes zoster, psoriasis, cellulitis, cyst, furunculosis, herpes simplex, hyperkeratosis, basal cell carcinoma, skin cancer. Rare: Desquamation, seborrhea, squamous cell carcinoma, ulcer (skin), skin necrosis, melanoma.
Infrequent: Hematuria, renal stone, kidney infection, glycosuria, dysuria, polyuria, nocturia, pyuria, cystitis, urinary retention, urination urgency, vaginal hemorrhage, pruritus (genital), breast pain, impotence, prostate cancer. Rare: Bladder tumor, renal tumor, renal failure, urinary obstruction, breast cancer, epididymitis, carcinoma (ovary).
Frequent: Conjunctivitis. Infrequent: Cataract, eyes dry, eye pain, visual field defect, diplopia, amblyopia, glaucoma, hordeolum, deafness, earache, tinnitus, inner ear infection, otitis media, unusual taste. Rare: Vision loss, ptosis, blepharitis, labyrinthitis, inner ear disturbance.
Postintroduction Reports
Voluntary reports of adverse events temporally associated with Cognex® that have been received since market introduction, that are not listed above, and that may have no causal relationship with the drug include the following: pancreatitis, perforated peptic ulcer, and falling.
Side Effects by Body System - for Healthcare Professionals
Hepatic
Elevations in LFTs (liver function tests) have been reported in as many as 50% of patients started on tacrine 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.
TopMore Cognex resources
- Cognex Prescribing Information (FDA)
- Cognex Concise Consumer Information (Cerner Multum)
- Cognex Monograph (AHFS DI)
- Cognex Advanced Consumer (Micromedex) - Includes Dosage Information
- Cognex MedFacts Consumer Leaflet (Wolters Kluwer)
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