, scrotal/penile edema, thirst, weakness, weight increase
Cardiovascular System Disorders (<5%) angina, arrhythmia, atrial fibrillation, bradycardia, cardiac failure, cardiomegaly, cardiomyopathy, coronary artery disorder, extrasystoles, heart valve disorder, hematoma, hypertension (9% in chronic hepatitis C), hypotension, palpitations, phlebitis, postural hypotension, pulmonary embolism, Raynaud's disease, tachycardia, thrombosis, varicose vein
Endocrine System Disorders (<5%) aggravation of diabetes mellitus, goiter, gynecomastia, hyperglycemia, hyperthyroidism, hypertriglyceridemia, hypothyroidism, virilism
Flu-like Symptoms
fever 81 56 68 56 47 55 34 66 86 94
headache 62 21 39 47 36 21 43 61 44 57
chills 54 - - 46 45 - - - - - - - - - - - -
myalgia 75 16 39 44 34 28 43 59 40 27
fatigue 96 8 61 18 84 48 23 75 69 71
increased sweating 6 13 8 2 4 21 4 1 1 3
asthenia - - 63 7 - - 11 - - 40 5 15 5
rigors 2 7 - - - - 30 14 16 38 42 30
arthralgia 6 8 8 9 - - 3 16 19 8 15
dizziness 23 - - 12 9 7 24 9 13 10 8
influenza-like symptoms 10 18 37 - - 45 79 26 5 - - <1
back pain - - 15 19 6 1 3 - - - - - - - -
dry mouth 1 2 19 - - 22 28 5 6 5 - -
chest pain 2 8 <1 <1 1 28 4 4 - - - -
malaise 6 - - - - 14 5 - - 13 9 6 3
pain (unspecified) 15 9 18 3 3 3 - - - - - - - -
other (<5%) chest pain substernal, hyperthermia, rhinitis, rhinorrhea
Gastrointestinal System Disorders
diarrhea 35 19 18 2 18 45 13 19 8 12
anorexia 69 21 19 1 38 41 14 43 53 43
nausea 66 24 21 17 28 21 19 50 33 18
taste alteration 24 2 13 <1 5 7 2 10 - - - -
abdominal pain 2 20 <5 1 5 21 16 5 4 23
loose stools - - 1 - - <1 - - 10 2 2 - - 2
vomiting ‡ 32 6 2 11 14 8 7 10 27
constipation 1 14 <1 - - 1 10 4 5 - - 2
gingivitis 2§ 7§ - - - - - - 14 - - 1 - - - -
dyspepsia - - 2 - - 2 4 - - 7 3 8 3
other (<5%) abdominal ascites, abdominal distension, colitis, dysphagia, eructation, esophagitis, flatulence, gallstones, gastric ulcer, gastritis, gastroenteritis, gastrointestinal disorder (7% in follicular lymphoma), gastrointestinal hemorrhage, gastrointestinal mucosal discoloration, gingival bleeding, gum hyperplasia, halitosis, hemorrhoids, increased appetite, increased saliva, intestinal disorder, melena, mouth ulceration, mucositis, oral hemorrhage, oral leukoplakia, rectal bleeding after stool, rectal hemorrhage, stomatitis, stomatitis ulcerative, taste loss, tongue disorder, tooth disorder
Liver and Biliary System Disorders (<5%) abnormal hepatic function tests, biliary pain, bilirubinemia, hepatitis, increased lactate dehydrogenase, increased transaminases (SGOT/SGPT) (elevated SGOT 63% in malignant melanoma and 24% in follicular lymphoma), jaundice, right upper quadrant pain (15% in chronic hepatitis C), and very rarely, hepatic encephalopathy, hepatic failure, and death
Musculoskeletal System Disorders
musculoskeletal pain - - 18 - - - - - - - - 21 9 1 10
Other (<5%) arteritis, arthritis, arthritis aggravated, arthrosis, bone disorder, bone pain, carpal tunnel syndrome, hyporeflexia, leg cramps, muscle atrophy, muscle weakness, polyarteritis nodosa, tendinitis, rheumatoid arthritis, spondylitis
Nervous System and Psychiatric Disorders
depression 40 9 6 3 9 28 19 17 6 4
paresthesia 13 13 6 1 3 21 5 6 3 &l |
