The occurrence of less commonly reported adverse clinical events is presented in this section. Because the reports include events observed in an open-label, long-term safety study in which TREXIMET was used as needed for up to 12 months, the role of TREXIMET cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used TREXIMET and reported an event divided by the total number of patients (N = 3,302) exposed to TREXIMET. Events listed in the previous table and text are not included below. Those events described too generally to be informative or those unlikely to be associated with the use of TREXIMET are excluded. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients. 

Blood and Lymphatic Disorders: Infrequent was lymphadenopathy. Rare were anemia, ecchymosis, leukopenia.

Cardiac Disorders: Infrequent was tachycardia. Rare were acute coronary syndrome, cardiac flutter, congestive cardiac failure, right ventricular failure, ventricular extrasystoles.

Ear and Labyrinth Disorders: Infrequent were ear pain, tinnitus. Rare were motion sickness, vertigo.

Endocrine, Metabolic, and Nutrition Disorders: Rare were diabetes mellitus, goiter, hypoglycemia, hypothyroidism.

Eye Disorders: Infrequent was conjunctivitis. Rare were cataract, conjunctival hemorrhage, visual disturbance.

Gastrointestinal Disorders: Frequent was abdominal pain. Infrequent were abdominal distention, constipation, diarrhea, dysgeusia, dysphagia, flatulence, gastritis, gastroesophageal reflux disease, vomiting. Rare were colitis, diverticulitis, gastric ulcer, irritable bowel syndrome, oral mucosal blistering, swollen tongue.

General Disorders: Frequent was fatigue. Infrequent were feeling jittery, lethargy, malaise, peripheral edema, pyrexia, temperature intolerance, thirst. Rare was difficulty in walking.

Hepatobiliary Disorders: Rare was biliary colic.

Infections and Infestations: Rare were kidney infection, pneumonia, sepsis, staphylococcal infection, viral myocarditis.

Musculoskeletal and Connective Tissue: Infrequent were arthralgia, back pain, muscular weakness, myalgia, sensation of heaviness.

Nervous System Disorders: Infrequent were burning sensation, disturbance of attention, insomnia, mental impairment, tremor. Rare were aphasia, facial palsy, impairment of psychomotor skills, sedation.

Psychiatric Disorders: Infrequent were anxiety, depression, irritability, nervousness. Rare were disorientation, panic attack.

Renal and Urinary Disorders: Infrequent was nephrolithiasis. Rare was renal insufficiency.

Respiratory, Thoracic, and Mediastinal: Infrequent were asthma, cough, dyspnea, oropharyngeal swelling. Rare was pleurisy.

Skin and Subcutaneous Disorders: Infrequent were facial swelling, hyperhydrosis, pruritus, rash, urticaria. Rare was systemic lupus erythematosus.

Vascular Disorders: Infrequent were flushing, hot flush, hypertension. Rare were epistaxis, peripheral coldness.