Zestoretic side effects

# List of side effects
Anaphylactoid and Possibly Related Reactions
Head and Neck Angioedema
Intestinal Angioedema
Anaphylactoid Reactions During Desensitization
Anaphylactoid Reactions During Membrane Exposure
Hypotension and Related Effects
Hepatic Failure
Pregnancy

## Anaphylactoid and Possibly Related Reactions
Presumably
because angiotensin-converting enzyme inhibitors affect the
metabolism of eicosanoids and polypeptides, including
endogenous bradykinin, patients receiving ACE inhibitors
(including ZESTORETIC) may be subject to a variety of
adverse reactions, some of them serious. Return to top

## Head and Neck Angioedema
Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been
reported rarely in patients treated with angiotensin-converting
enzyme inhibitors, including lisinopril. This may occur at any
time during treatment. ACE inhibitors have been associated
with a higher rate of angioedema in black than in nonblack
patients. ZESTORETIC should be promptly discontinued and
the appropriate therapy and monitoring should be provided
until complete and sustained resolution of signs and symptoms
has occurred. Where there is involvement of the
tongue, glottis or larynx, likely to cause airway
-bstruction, subcutaneous epinephrine solution 1:1000 (0.3
mL to 0.5 mL) and/or measures necessary to ensure a
patent airway should be promptly provided. Return to top

## Intestinal Angioedema
Intestinal angioedema has been
reported in patients treated with ACE inhibitors. These
patients presented with abdominal pain (with or without
nausea or vomiting); in some cases there was no prior history
-f facial angioedema and C-1 esterase levels were normal.
The angioedema was diagnosed by procedures including
abdominal CT scan or ultrasound, or at surgery, and
symptoms resolved after stopping the ACE inhibitor.
Intestinal angioedema should be included in the differential
diagnosis of patients on ACE inhibitors presenting with
abdominal pain. Return to top

## Anaphylactoid Reactions During Desensitization
Two patients undergoing desensitizing treatment with hymenoptera
venom while receiving ACE inhibitors sustained life
threatening anaphylactoid reactions. In the same patients,
these reactions were avoided when ACE inhibitors were
temporarily withheld, but they reappeared upon inadvertent
rechallenge. Return to top

## Anaphylactoid Reactions During Membrane Exposure
Thiazide-containing combination products are not
recommended in patients with severe renal dysfunction.
Sudden and potentially life-threatening anaphylactoid
reactions have been reported in some patients dialyzed with
high-flux membranes (eg, AN69*) and treated concomitantly
with an ACE inhibitor. In such patients, dialysis must be
stopped immediately, and aggressive therapy for
anaphylactoid reactions be initiated. Symptoms have not been
relieved by antihistamines in these situations. In these
patients, consideration should be given to using a different
type of dialysis membrane or a different class of
antihypertensive agent. Return to top

## Hypotension and Related Effects
Excessive hypotension was rarely seen in uncomplicated hypertensive patients but is
a possible consequence of lisinopril use in
salt/volume-depleted persons such as those treated vigorously
with diuretics or patients on dialysis. Return to top

## Hepatic Failure
Rarely, ACE inhibitors have been
associated with a syndrome that starts with cholestatic
jaundice or hepatitis and progresses to fulminant hepatic
necrosis and (sometimes) death. The mechanism of this
syndrome is not understood. Patients receiving ACE
inhibitors who develop jaundice or marked elevations of
hepatic enzymes should discontinue the ACE inhibitor and
receive appropriate medical follow-up. Return to top

## Pregnancy
When used in pregnancy during the second and third
trimesters, ACE inhibitors can cause injury and even death to
the developing fetus. When pregnancy is detected,
ZESTORETIC should be discontinued as soon as possible. Return to top
Adapted from the FDA Package Insert.