A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Prilosec Side Effects, and Drug Interactions - Omeprazole
Prilosec Side Effects, and Drug Interactions - Omeprazole
SIDE EFFECTS
Omeprazole delayed-release capsules were generally well tolerated
during domestic and international clinical
trials in 3096 patients.
In the U.S. clinical
trial population
of 465 patients (including duodenal ulcer, Zollinger-Ellison syndrome
and resistant ulcer patients),
the following adverse experiences were reported to occur in 1% or
more of patients on therapy with omeprazole. Numbers in parentheses
indicate percentages of the adverse experiences considered by investigators
as possibly, probably or definitely related to the drug
(TABLE 14).
| TABLE 14 |
| |
Omeprazole |
Placebo |
Ranitidine |
| |
(n=465) |
(n=64) |
(n=195) |
| Headache |
6.9 (2.4) |
6.3 |
7.7 (2.6) |
| Diarrhea |
3.0 (1.9) |
3.1 (1.6) |
2.1 (0.5) |
| Abdominal Pain |
2.4 (0.4) |
3.1 |
2.1 |
| Nausea |
2.2 (0.9) |
3.1 |
4.1 (0.5) |
| URI |
1.9 |
1.6 |
2.6 |
| Dizziness |
1.5 (0.6) |
0.0 |
2.6 (1.0) |
| Vomiting |
1.5 (0.4) |
4.7 |
1.5 (0.5) |
| Rash |
1.5 (1.1) |
0.0 |
0.0 |
| Constipation |
1.1 (0.9) |
0.0 |
0.0 |
| Cough |
1.1 |
0.0 |
1.5 |
| Asthenia |
1.1 (0.2) |
1.6 (1.6) |
1.5 (1.0) |
| Back Pain |
1.1 |
0.0 |
0.5 |
The following adverse reactions which occurred in 1% or more of
omeprazole-treated patients have been reported in international
double-blind, and open-label, clinical trials in which 2631 patients
and subjects received omeprazole (see TABLE 15).
| TABLE 15 Incidence of Adverse
Experiences ³ 1%, Causal Relationship
Not Assessed |
| |
Omeprazole |
Placebo |
| |
(n=2631) |
(n=120) |
| Body As
A Whole, Site Unspecified |
| Abdominal Pain |
5.2 |
3.3 |
| Asthenia |
1.3 |
0.8 |
| Digestive System |
| Constipation |
1.5 |
0.8 |
| Diarrhea |
3.7 |
2.5 |
| Flatulence |
2.7 |
5.8 |
| Nausea |
4.0 |
6.7 |
| Vomiting |
3.2 |
10.0 |
| Acid regurgitation |
1.9 |
3.3 |
| Nervous System/Psychiatric |
| Headache |
2.9 |
2.5 |
Additional adverse experiences occurring in < 1% of patients
or subjects in domestic and/or international trials, or occurring
since the drug was marketed,
are shown below within each body system. In
many instances, the relationship to omeprazole
was unclear.
Body As a Whole:
Fever, pain, fatigue, malaise, abdominal swelling.
Cardiovascular: Chest pain
or angina, tachycardia, bradycardia, palpitation, elevated blood
pressure, peripheral
edema.
Gastrointestinal: Pancreatitis (some fatal), anorexia,
irritable colon, flatulence, fecal discoloration, esophageal
candidiasis, mucosal atrophy of the tongue, dry mouth. During treatment
with omeprazole, gastric fundic
gland polyps have been
noted rarely. These polyps are benign and appear to be reversible
when treatment is
discontinued. Gastro-duodenal carcinoids have been reported in patients
with ZE syndrome on
long-term treatment with omeprazole. This finding is believed to
be a manifestation of the underlying condition, which is known to
be associated with such tumors.
Hepatic: Mild and, rarely, marked elevations of liver
function tests [ALT (SGPT), AST
(SGOT), g-glutamyl transpeptidase, alkaline
phosphatase, and bilirubin
(jaundice)]. In rare instances,
overt liver disease
has occurred, including hepatocellular, cholestatic, or mixed
hepatitis, liver necrosis
(some fatal), hepatic
failure (some fatal), and hepatic
encephalopathy.
Metabolic/Nutritional: Hypoglycemia, weight
gain.
Musculoskeletal: Muscle cramps, myalgia, muscle
weakness, joint pain, leg
pain.
Nervous System/Psychiatric: Psychic disturbances
including depression, aggression, hallucinations, confusion, insomnia,
nervousness, tremors, apathy, somnolence, anxiety, dream
abnormalities; vertigo; paresthesia; hemifacial dysesthesia.
Respiratory: Epistaxis, pharyngeal
pain.
Skin: Rash and, very rarely, cases of severe generalized
skin reactions including toxic
epidermal necrolysis
(TEN; some fatal), Stevens-Johnson syndrome, and erythema
multiforme (some severe); skin
inflammation, urticaria, angioedema, pruritus, alopecia, dry skin,
hyperhidrosis.
Special Senses: Tinnitus, taste
perversion.
Urogenital: Interstitial nephritis
(some with positive rechallenge), urinary tract
infection, microscopic pyuria, urinary frequency, elevated serum
creatinine, proteinuria, hematuria, glycosuria, testicular pain,
gynecomastia.
Hematologic: Rare instances of pancytopenia, agranulocytosis
(some fatal), thrombocytopenia, neutropenia, anemia, leucocytosis,
and hemolytic anemia
have been reported.
The incidence of
clinical adverse experiences
in patients greater than 65 years of age
was similar to that in patients 65 years of age
or less.
Combination Therapy with Clarithromycin: In
clinical trials using
combination therapy with omeprazole
and clarithromycin, no adverse experiences peculiar to this drug
combination have been observed. Adverse experiences that have occurred
have been limited to those that have been previously reported with
omeprazole or clarithromycin.
Adverse experiences observed in controlled clinical
trials using combination therapy with omeprazole
and clarithromycin (n=346) which differed from those previously
described for omeprazole
alone were: Taste perversion (15%), tongue
discoloration (2%), rhinitis
(2%), pharyngitis
(1%) and flu syndrome (1%).
For more information on clarithromycin, refer to Clarithromycin,
SIDE EFFECTS
.
DRUG INTERACTIONS
Other
Omeprazole can prolong the elimination
of diazepam, warfarin and phenytoin, drugs that are metabolized
by oxidation in the
liver. Although in normal subjects no interaction with theophylline
or propranolol was found, there have been clinical
reports of interaction with other drugs metabolized via the cytochrome
P-450 system (e.g.,
cyclosporine, disulfiram, benzodiazepines). Patients should be monitored
to determine if it is necessary to adjust the dosage
of these drugs when taken concomitantly with omeprazole.
Because of its profound and long lasting inhibition
of gastric acid secretion,
it is theoretically possible that omeprazole
may interfere with absorption of drugs where gastric
pH is an important determinant
of their bioavailability (e.g., ketoconazole, ampicillin
esters, and iron salts). In
the clinical trials,
antacids were used concomitantly with the administration of omeprazole.
Combination Therapy with Clarithromycin
Co-administration of omeprazole
and clarithromycin may result in increases in plasma
levels of ompeprazole, clarithromycin, and 14-hydroxy-clarithromycin.
(See also CLINICAL PHARMACOLOGY,
Combination Therapy with Clarithromycin, Pharmacokinetics)
Concomitant administration
of clarithromycin with cisapride, pimozide, or terfenadine is contraindicated.
There have been reports of an intereaction between erythromycin
and astemizole resulting in QT prolongation and torsades de points. Concomitant
administration of erythromycin
and astemizole is contraindicated. Because clarithromycin is also metabolized
by cytochrome P450, concomitant
administration of clarithromycin with astemizole is not recommended. (See
also CONTRAINDICATIONS, Clarithromycin.
Please refer to clarithromycin before prescribing.)
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