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
Protonix Side Effects, and Drug Interactions - Pantoprazole
Protonix Side Effects, and Drug Interactions - Pantoprazole
SIDE EFFECTS
Safety Experience with Intravenous Pantoprazole
Intravenous pantoprazole has been well tolerated in clinical trials of GERD
patients and healthy subjects. A double-blind placebo controlled study conducted
in the U.S. evaluated the effect of PROTONIX I.V. for Injection on pentagastrin-stimulated
acid secretion in 65 GERD patients. Treatment-emergent events considered possibly,
probably or definitely drug-related that were reported by 2 or more patients
( ≥4%) taking PROTONIX I.V. (pantoprazole sodium) for Injection (n=50) and
by 0% of patients taking placebo (n=15) were: abdominal pain (12%), chest pain
(6%), rash (6%), and pruritus (4%).
Additional adverse experiences occurring in >1% of GERD patients treated
with intravenous pantoprazole (n=412) in domestic (n=50) or international (n=362)
clinical trials are shown below by body system. In most instances, the relationship
to pantoprazole was unclear.
BODY AS A WHOLE: headache, injection site reaction.
DIGESTIVE SYSTEM: dyspepsia, nausea, diarrhea, vomiting.
NERVOUS SYSTEM: dizziness.
RESPIRATORY SYSTEM: rhinitis.
The safety of intravenous pantoprazole has also been evaluated during international
clinical trials conducted in over 300 critically ill patients. The safety profile
of intravenous pentoprazole was similar to that of oral pantoprazole with the
exception of injection site reactions including injection site inflammation,
thrombophlebitis, hemorrhage, and abscess. Head-to-head comparative studies
between PROTONIX I.V. for Injection and oral PROTONIX, other proton pump inhibitors
(oral or I.V.), or H2 receptor antagonists (oral or I.V.) have been limited.
The available information does not provide sufficient evidence to distinguish
the safety profile of these regimens.
Safety Experience with Oral Pantoprazole
In short-term clinical trials in GERD patients treated with oral pantoprazole,
the following adverse events, regardless of causality, occurred at a rate of
≥1%.
BODY AS A WHOLE: headache, asthenia, back pain, chest pain, neck
pain, flu syndrome, infection, pain.
CARDIOVASCULAR SYSTEM: migraine.
DIGESTIVE SYSTEM: diarrhea, flatulence, abdominal pain, eructation,
constipation, dyspepsia, gastroenteritis, gastrointestinal disorder, nausea,
rectal disorder, vomiting.
HEPATO-BILIARY SYSTEM: liver function tests abnormal, SGPT increased.
METABOLIC AND NUTRITIONAL: hyperglycemia, hyperlipemia.
MUSCULOSKELETAL SYSTEM: arthralgia.
NERVOUS SYSTEM: insomnia, anxiety, dizziness, hypertonia.
RESPIRATORY SYSTEM: bronchitis, cough increased, dyspnea, pharyngitis,
rhinitis, sinusitis, upper respiratory tract infection.
SKIN AND APPENDAGES: rash.
UROGENITAL SYSTEM: urinary frequency, and urinary tract infection.
Additional adverse experiences occurring in <1% of GERD patients receiving
oral pantoprazole based on pooled results from either short-term domestic or
international trials are shown below within each body system. In most instances,
the relationship to pantoprazole was unclear.
BODY AS A WHOLE: abscess, allergic reaction, chills, cyst, face
edema, fever, generalized edema, heat stroke, hernia, laboratory test abnormal,
malaise, moniliasis, neoplasm, non-specified drug reaction.
CARDIOVASCULAR SYSTEM: angina pectoris, arrhythmia, cardiovascular
disorder, chest pain substernal, congestive heart failure, electrocardiogram
abnormal, hemorrhage, hypertension, hypotension, myocardial ischemia, palpitation,
retinal vascular disorder, syncope, tachycardia, thrombophlebitis, thrombosis,
vasodilatation.
DIGESTIVE SYSTEM: anorexia, aphthous stomatitis, cardiospasm, colitis,
dry mouth, duodenitis, dysphagia, enteritis, esophageal hemorrhage, esophagitis,
gastrointestinal carcinoma, gastrointestinal hemorrhage, gastrointestinal moniliasis,
gingivitis, glossitis, halitosis, hematemesis, increased appetite, melena, mouth
ulceration, oral moniliasis, periodontal abscess, periodonitis, rectal hemorrhage,
stomach ulcer, stomatitis, stools abnormal, tongue discoloration, ulcerative
colitis.
ENDOCRINE SYSTEM: diabetes mellitus, glycosuria, goiter.
HEPATO-BILIARY SYSTEM: biliary pain, hyperbilirubinemia, cholecystitis,
cholelithiasis, cholestatic jaundice, hepatitis, alkaline phosphatase increased,
gamma glutamyl transpeptidase increased, SGOT increased.
HEMIC AND LYMPHATIC SYSTEM: anemia, ecchymosis, eosinophilia, hypochromic
anemia, iron deficiency anemia, leukocytosis, leukopenia, thrombocytopenia.
METABOLIC AND NUTRITIONAL: dehydration, edema, gout, peripheral
edema, thirst, weight gain, weight loss.
MUSCULOSKELETAL SYSTEM: arthritis, arthrosis, bone disorder, bone
pain, bursitis, joint disorder, leg cramps, neck rigidity, myalgia, tenosynovitis.
NERVOUS SYSTEM: abnormal dreams, confusion, convulsion, depression,
dry mouth, dysarthria, emotional lability, hallucinations, hyperkinesia, hypesthesia,
libido decreased, nervousness, neuralgia, neuritis, paresthesia, reflexes decreased,
sleep disorder, somnolence, thinking abnormal, tremor, vertigo.
RESPIRATORY SYSTEM: asthma, epistaxis, hiccup, laryngitis, lung
disorder, pneumonia, voice alteration.
SKIN AND APPENDAGES: acne, alopecia, contact dermatitis, dry skin,
eczema, fungal dermatitis, hemorrhage, herpex simplex, herpes zoster, lichenoid
dermatitis, maculopapular rash, pain, pruritus, skin disorder, skin ulcer, sweating,
urticaria.
SPECIAL SENSES: abnormal vision, amblyopia, cataract specified,
deafness, diplopia, ear pain, extraocular palsy, glaucoma, otitis externa, taste
perversion, tinnitus.
UROGENITAL SYSTEM: albuminuria, balanitis, breast pain, cystitis,
dysmenorrhea, dysuria, epididymitis, hematuria, impotence, kidney calculus,
kidney pain, nocturia, prostatic disorder, pyelonephritis, scrotal edema, urethral
pain, urethritis, urinary tract disorder, urination impaired, vaginitis.
Postmarketing Reports
There have been spontaneous reports of adverse events with postmarketing use
of intravenous or oral pantoprazole. These reports include anaphylaxis (including
anaphylactic shock); angioedema (Quincke's edema); anterior ischemic optic neuropathy;
severe dermatologic reactions, including erythema multiforme, Stevens-Johnson
syndrome, and toxic epidermal necrolysis (TEN, some fatal); hepatocellular damage
leading to jaundice and hepatic failure; and pancreatitis.
In addition, also observed have been confusion, hypokinesia, speech disorder,
increased salivation, vertigo, nausea, tinnitus, and blurred vision.
Laboratory Values
In U.S. and international GERD clinical trials, the overall percentages of
transaminase elevations did not increase during treatment with intravenous pantoprazole.
For other laboratory parameters, there were no clinically important changes
identified.
In two U.S. controlled trials of oral pantoprazole in patients with GERD, 0.4%
of the patients on 40 mg oral pantoprazole experienced SGPT elevations of greater
than three times the upper limit of normal at the final treatment visit. Except
in those patients where there was a clear alternative explanation for a laboratory
value change, such as intercurrent illness, the elevations tended to be mild
and sporadic. The following changes in laboratory parameters were reported as
adverse events: creatinine increased, hypercholesterolemia, and hyperuricemia.
DRUG INTERACTIONS
(see CLINICAL PHARMACOLOGY, Drug-Drug
Interactions )
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