erse reactions not listed above that have been reported with hydrochlorothiazide, without regard to causality, are listed below:
Body as a Whole: weakness
Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation
Hematologic: aplastic anemia, agranulocytosis, hemolytic anemia
Hypersensitivity: photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions
Metabolic: glycosuria, hyperuricemia
Nervous System/Psychiatric: restlessness
Renal: renal failure, renal dysfunction, interstitial nephritis
Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis
Special Senses: transient blurred vision, xanthopsia.
Preferred Term |
Aml/Val/HCTZ
10/320/25 mg
N=582
n (%) |
Val/HCTZ
320/25 mg
N=559
n (%) |
Aml/Val
10/320 mg
N=566
n (%) |
HCTZ/Aml
25/10 mg
N=561
n (%) |
|
Dizziness |
48 (8.2) |
40 (7.2) |
14 (2.5) |
23 (4.1) |
|
Edema |
38 (6.5) |
8 (1.4) |
65 (11.5 ) |
63 (11.2) |
|
Headache |
30 (5.2) |
31 (5.5) |
30 (5.3) |
40 (7.1) |
|
Dyspepsia |
13 (2.2) |
5 (0.9) |
6 (1.1) |
2 (0.4) |
|
Fatigue |
13 (2.2) |
15 (2.7) |
12 (2.1) |
8 (1.4) |
|
Muscle spasms |
13 (2.2) |
7 (1.3) |
7 (1.2) |
5 (0.9) |
|
Back pain |
12 (2.1) |
13 (2.3) |
5 (0.9) |
12 (2.1) |
|
Nausea |
12 (2.1) |
7 (1.3) |
10 (1.8) |
12 (2.1) |
|
Nasopharyngitis |
12 (2.1) |
13 (2.3) |
13 (2.3) |
12 (2.1) |
Amlodipine
With amlodipine, gynecomastia has been reported infrequently and a causal relationship is uncertain. Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
Valsartan
The following additional adverse reactions have been reported in post-marketing experience with valsartan or valsartan/hydrochlorothiazide:
Blood and Lymphatic: There are very rare reports of thrombocytopenia.
Hypersensitivity: There are rare reports of angioedema.
Digestive: Elevated liver enzymes and very rare reports of hepatitis
Renal: Impaired renal function
Clinical Laboratory Tests: Hyperkalemia
Dermatologic: Alopecia
Vascular: Vasculitis
Nervous System: Syncope
Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliabl
