Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Protonix

Last reviewed on RxList: 10/24/2018
Protonix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/24/2018

Protonix Delayed-Release Oral Suspension and Delayed-Release Tablets (pantoprazole sodium) is a proton pump inhibitor (PPI) used for short-term treatment (less than 10 days) of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis in adult patients. Common side effects of Protonix include

The recommended adult dose of Protonix is 40 mg once daily. Protonix may interact with atazanavir, nelfinavir, ampicillin, blood thinners, digoxin, diuretics (water pills), ketoconazole, iron, or methotrexate. Tell your doctor all medications and supplements you use. Protonix is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Protonix. Protonix passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Protonix 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.

Protonix Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • sudden pain or trouble moving your hip, wrist, or back;
  • bruising or swelling where intravenous pantoprazole was injected;
  • kidney problems--urinating less than usual, blood in your urine, swelling, rapid weight gain;
  • low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
  • new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking pantoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use pantoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

  • headache, dizziness;
  • stomach pain, gas, nausea, vomiting, diarrhea;
  • joint pain; or
  • fever, rash, or cold symptoms (most common in children).

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.

Read the entire detailed patient monograph for Protonix (Pantoprazole)

Protonix Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

Clinical Trials Experience

The adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets are similar.

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.

Adults

Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral PROTONIX (20 mg or 40 mg), 299 patients on an H2-receptor antagonist, 46 patients on another PPI, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 3.

Table 3: 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 clinical trials with a frequency of ≤ 2% are listed below by body system:

Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema

Gastrointestinal: constipation, dry mouth, hepatitis

Hematologic: leukopenia, thrombocytopenia

Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated

Musculoskeletal: myalgia

Nervous: depression, vertigo

Skin and Appendages: urticaria, rash, pruritus

Special Senses: blurred vision

Pediatric Patients

Safety of PROTONIX in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials. Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to PROTONIX are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (> 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

For safety information in patients less than 1 year of age see Use In Specific Populations. Additional adverse reactions that were reported for PROTONIX in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system:

Body as a Whole: allergic reaction, facial edema

Gastrointestinal: constipation, flatulence, nausea

Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase)

Musculoskeletal: arthralgia, myalgia

Nervous: dizziness, vertigo

Skin and Appendages: urticaria

The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and 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

Hematologic: pancytopenia, agranulocytosis

Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure

Immune System Disorders: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus

Infections and Infestations: Clostridium difficile associated diarrhea

Investigations: weight changes

Metabolism and Nutritional Disorders: hyponatremia, hypomagnesemia

Musculoskeletal Disorders: rhabdomyolysis, bone fracture

Nervous: ageusia, dysgeusia

Psychiatric Disorders: hallucination, confusion, insomnia, somnolence

Renal and Urinary Disorders: interstitial nephritis

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

Read the entire FDA prescribing information for Protonix (Pantoprazole)

Related Resources for Protonix

Read the Protonix User Reviews »

© Protonix Patient Information is supplied by Cerner Multum, Inc. and Protonix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED ARTICLE