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adverse reactions
ADVERSE REACTIONS Over 6000 patients have been treated with TROVAN in multidose clinical efficacy trials worldwide. In TROVAN studies the majority of adverse reactions were described as mild in nature (over 90% were described as mild or moderate). TROVAN was discontinued for adverse events thought related to drug in 5% of patients (dizziness 2.4%, nausea 1.9%, headache 1.1%, and vomiting 1.0%). TROVAN Drug-Related Adverse Reactions (frequency ≥1%) in Multiple-Dose Clinical Trials 200 mg oral qd (N=3259) 200 mg I.V.→ 200 mg oral qd (N=634) 300 mg I.V.→ 200 mg oral qd (N=623) Dizziness 11% 2% 2% Lightheadedness 4% 2% <1% Nausea 8% 5% 4% Headache 5% 5% 1% Vomiting 3% 1% 3% Diarrhea 2% 2% 2% Abdominal pain 1% 1% 0% Application/ injection/insertion site n/a 5% 2% reaction/ Vaginitis 2% 2% <1% Pruritus <1% 2% 2% Rash <1% 2% 2% Dizziness/lightheadedness on TROVAN is generally mild, lasts for a few hours following a dose, and in most cases, resolves with continued dosing. The incidence of dizziness and lightheadedness in TROVAN patients over 65 years is 3.1% and 0.6%, respectively. (See PRECAUTIONS: Information for Patients .) TROVAN appears to have a low potential for phototoxicity. In clinical trials with TROVAN, only mild, treatment-related phototoxicity was observed in less than 0.03% (2/7096) of patients. Additional reported drug-related events in clinical trials (remotely, possibly, probably or unknown) that occurred in <1% of TROVAN-treated patients are: APPLICATION/INJECTION/INSERTION SITE: Application/injection/insertion site device complications, inflammation, pain, edema AUTONOMIC NERVOUS: flushing, increased sweating, dry mouth, cold clammy skin, increased saliva CARDIOVASCULAR: peripheral edema, chest pain, thrombophlebitis, hypotension, palpitation, periorbital edema, hypertension, syncope, tachycardia, angina pectoris, bradycardia, peripheral ischemia, edema, dizziness postural CENTRAL & PERIPHERAL NERVOUS SYSTEM: confusion, paresthesia, vertigo, hypoesthesia, ataxia, convulsions, dysphonia, hypertonia, migraine, involuntary muscle contractions, speech disorder, encephalopathy, abnormal gait, hyperkinesia, hypokinesia, tongue paralysis, abnormal coordination, tremor, dyskinesia GASTROINTESTINAL: altered bowel habit, constipation, diarrhea- Clostridium difficile , dyspepsia, flatulence, loose stools, gastritis, dysphagia, increased appetite, gastroenteritis, rectal disorder, colitis, pseudomembranous colitis, enteritis, eructation, gastrointestinal disorder, melena, hiccup ORAL CAVITY: gingivitis, stomatitis, altered saliva, tongue disorder, tongue edema, tooth disorder, cheilitis, halitosis GENERAL/OTHER: fever, fatigue, pain, asthenia, moniliasis, hot flushes, back pain, chills, infection (bacterial, fungal), malaise, sepsis, alcohol intolerance, allergic reaction, anaphylactoid reaction, drug (other) toxicity/reaction, weight increase, weight decrease HEMATOPOIETIC: anemia, granulocytopenia, hemorrhage unspecified, leukopenia, prothrombin decreased, thrombocythemia, thrombocytopenia LIVER/BILIARY: increased hepatic enzymes, hepatic function abnormal, bilirubinemia, discolored feces, jaundice METABOLIC/NUTRITIONAL: hyperglycemia, thirst MUSCULOSKELETAL: arthralgia, muscle cramps, myalgia, muscle weakness, skeletal pain, tendinitis, arthropathy PSYCHIATRIC: anxiety, anorexia, agitation, nervousness, somnolence, insomnia, depression, amnesia, concentration impaired, depersonalization, dreaming abnormal, emotional lability, euphoria, hallucination, impotence, libido decreased-male, paroniria, thinking abnormal REPRODUCTIVE: Female: leukorrhea, menstrual disorder; Male: balanoposthitis RESPIRATORY: dyspnea, rhinitis, sinusitis, bronchospasm, coughing, epistaxis, respiratory insufficiency, upper respiratory tract infection, respiratory disorder, asthma, hemoptysis, hypoxia, stridor SKIN/APPENDAGES: pruritus ani, skin disorder, skin ulceration, angioedema, dermatitis, dermatitis fungal, photosensitivity skin reaction, seborrhea, skin exfoliation, urticaria SPECIAL SENSES: taste perversion, eye pain, abnormal vision, conjunctivitis, photophobia, conjuctival hemorrhage, hyperacusis, scotoma, tinnitus, visual field defect, diplopia, xerophthalmia URINARY SYSTEM: dysuria, face edema, micturition frequency, interstitial nephritis, renal failure acute, renal function abnormal, urinary incontinence LABORATORY CHANGES: Changes in laboratory parameters, without regard to drug relationship, occurring in ≥1% of TROVAN-treated patients were: decreased hemoglobin and hematocrit; increased platelets; decreased and increased WBC; eosinophilia; increased ALT (SGPT), AST (SGOT), and alkaline phosphatase; decreased protein and albumin; increased BUN and creatinine; decreased sodium; and bicarbonate. It is not known whether these abnormalities were caused by the drug or the underlying condition being treated. The incidence and magnitude of liver function abnormalities with TROVAN were the same as comparator agents except in the only study in which oral TROVAN was administered for 28 days. In this study (chronic bacterial prostatitis) nine percent (13/140) of TROVAN-treated patients experienced elevations of serum transaminases (AST and/or ALT) of ≥3 times the upper limit of normal. These liver function test abnormalities generally developed at the end of, or following completion of, the planned 28-day course of therapy, but were not associated with concurrent elevations of related laboratory measures of hepatic function (such as serum bilirubin, alkaline phosphatase, or lactate dehydrogenase). Patients were asymptomatic with these abnormalities, which generally returned to normal within 1–2 months after discontinuation of therapy. (See ADVERSE REACTIONS: POST-MARKETING EXPERIENCE subsection.) POST-MARKETING EXPERIENCE Adverse reactions reported with TROVAN during the post-marketing period include: GASTROINTESTINAL: symptomatic pancreatitis. GENERAL/OTHER: anaphylaxis, Stevens-Johnson Syndrome. HEMATOPOIETIC: agranulocytosis, aplastic anemia, pancytopenia. LIVER/BILIARY: symptomatic hepatitis (some patients experienced an associated peripheral eosinophilia), liver failure (including acute hepatic necrosis with eosinophilic infiltration). TROVAN-associated liver enzyme abnormalities and/or symptomatic hepatitis have occurred during short-term or long-term therapy. (See WARNINGS .)