Protonix
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Protonix
Protonix Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Protonix (pantoprazole) is a medication in the proton-pump inhibitor (PPI) class used to treat esophagitis associated with gastroesophageal reflux disease (GERD). Protonix is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. Common side effects of Protonix include headache, diarrhea, nausea, and abdominal pain.
Long-term treatment with Protonix may make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown. Animal studies showed no harm during pregnancy; however there are no adequate and well-controlled studies in pregnant women, and this drug should be used during pregnancy only if clearly needed. Pantoprazole and its metabolites are excreted in the milk of rats. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Protonix in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using pantoprazole and call your doctor at once if you have symptoms of low magnesium such as:
- dizziness, confusion;
- fast or uneven heart rate;
- jerking muscle movements;
- feeling jittery;
- muscle cramps, muscle weakness or limp feeling;
- cough or choking feeling; or
- seizure (convulsions).
Less serious side effects are more likely to occur, such as:
- weight changes;
- nausea, vomiting, diarrhea;
- gas, stomach pain;
- dizziness, drowsiness, tired feeling;
- joint pain;
- sleep problems (insomnia); or
- headache.
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Protonix Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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 (Pantoprazole)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Protonix FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets are similar.
Clinical Trial 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.
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 proton pump inhibitor, 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
Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure
Immune System Disorders: anaphylaxis (including anaphylactic shock)
Investigations: weight changes
Metabolism and Nutritional Disorders: hyponatremia, hypomagnesemia
Musculoskeletal Disorders: rhabdomyolysis, bone fracture
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, and toxic epidermal necrolysis (TEN, some fatal), and angioedema (Quincke's edema)
Read the entire FDA prescribing information for Protonix (Pantoprazole) »
Additional Protonix Information
Protonix - User Reviews
Protonix 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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