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Protonix IV

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Protonix I.V.

Protonix IV Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Protonix IV (pantoprazole sodium) is used for short-term treatment (less than 10 days) of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis in adult patients. It is a proton pump inhibitor (PPI). Common side effects include redness/pain/swelling at the injection site, headache, nausea, or diarrhea.

Protonix IV is given by injection into a vein by a doctor. Protonix IV should not be used with atazanavir or nelfinavir because serious interactions may occur. Protonix IV may also interact with products that contain zinc, ampicillin, iron supplements, calcium supplements, dasatinib, or azole antifungals. Tell your doctor all medications and supplements you are taking. During pregnancy, Protonix IV should be used only when prescribed. This medication passes into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.

Our Protonix IV (pantoprazole sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Protonix IV Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Protonix IV (Pantoprazole Sodium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Protonix IV FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Worldwide, approximately 80,500 patients have been treated with pantoprazole in clinical trials involving various dosages and duration of treatment.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Gastroesophageal Reflux Disease (GERD)

Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole (20 mg or 40 mg), 299 patients on an H2-receptor antagonist, 46 patients on another proton pump inhibitor, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 1.

The number of patients treated in comparative studies with I.V. pantoprazole is limited; however, the adverse reactions seen were similar to those seen in the oral studies. Thrombophlebitis was the only new adverse reaction identified with I.V. pantoprazole.

Table 1: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2%

  PROTONIX
(n=1473) %
Comparators
(n=345) %
Placebo
(n=82) %
Headache 12.2 12.8 8.5
Diarrhea 8.8 9.6 4.9
Nausea 7.0 5.2 9.8
Abdominal pain 6.2 4.1 6.1
Vomiting 4.3 3.5 2.4
Flatulence 3.9 2.9 3.7
Dizziness 3.0 2.9 1.2
Arthralgia 2.8 1.4 1.2

Additional adverse reactions that were reported for PROTONIX in US clinical trials with a frequency of ≤ 2% are listed below by body system:

Body as a Whole: allergic reaction, fever, photosensitivity reaction, facial edema, thrombophlebitis (I.V. only)

Gastrointestinal: constipation, dry mouth, hepatitis

Hematologic: leukopenia (reported in ex-US clinical trials only), thrombocytopenia

Metabolic/Nutritional: elevated CPK (creatine phosphokinase), generalized edema, elevated triglycerides, liver function tests abnormal

Musculoskeletal: myalgia

Nervous: depression, vertigo

Skin and Appendages: urticaria, rash, pruritus

Special Senses: blurred vision

Zollinger-Ellison Syndrome

In clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients taking PROTONIX 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of PROTONIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are listed below by body system:

General Disorders and Administration Conditions: asthenia, fatigue, malaise

Immune System Disorders: anaphylaxis (including anaphylactic shock)

Investigations: weight changes

Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN), and angioedema (Quincke's edema)

Musculoskeletal Disorders: rhabdomyolysis, bone fracture

Renal and Urinary Disorders: interstitial nephritis

Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure

Psychiatric Disorder: hallucinations, confusion, insomnia, somnolence

Metabolism and Nutritional Disorders: hyponatremia, hypomagnesemia

Infections and Infestations: Clostridium difficile associated diarrhea

Hematologic: pancytopenia, agranulocytosis Nervous: ageusia, dysgeusia

Read the entire FDA prescribing information for Protonix IV (Pantoprazole Sodium) »

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Protonix I.V. - User Reviews

Protonix I.V. User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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