· Brand: Protonix Delayed-Release, Protonix + 2 more

Pantoprazole Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Acid reflux & GI

Quick answer

Based on 323,000+ FDA adverse event reports, the most-reported pantoprazole reactions include chronic kidney disease, fatigue, and nausea. FDA reports 2 active Class II recalls of pantoprazole, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Pantoprazole

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for pantoprazole. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Chronic Kidney Disease	29,228	9.0%
Fatigue	24,135	7.5%
Nausea	22,120	6.8%
Acute Kidney Injury	21,212	6.6%
Diarrhoea	20,632	6.4%
Dyspnoea	20,208	6.2%
Pain	18,910	5.8%
Headache	15,877	4.9%
Vomiting	15,198	4.7%
Renal Failure	14,704	4.5%

Source: FDA FAERS·Updated May 28, 2026·n=323,518+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—
Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established.	11,713	3.6%

From the FDA-approved label, Section 5.1: Presence of Gastric

Malignancy In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

From the FDA-approved label, Section 5.4: Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue pantoprazole sodium and evaluate patients with suspected acute TIN [see Contraindications (4) ] .

Source: DailyMed (pantoprazole label)·Updated May 28, 2026

Pantoprazole Recalls

FDA enforcement actions matched to pantoprazole via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2026-04-29	Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." Hetero Labs Limited (Unit V)	Class II	4,740 1,000-count bottles.	Ongoing
2023-04-19	CGMP Deviations: Discoloration Hetero USA Inc	Class II	2,352 bottles	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 8 closed recalls (2017 to 2023)

Includes resolved and terminated recalls matched to pantoprazole. Most recent first.

Date	Reason	Class	Quantity	Status
2023-09-20	Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. BE PHARMACEUTICALS AG	Class II	41,148 vials	Terminated
2022-11-30	Discoloration SUN PHARMACEUTICAL INDUSTRIES INC	Class II	14, 064 (30 sachets in a carton)	Terminated
2022-05-11	CGMP deviations: tablets cracking Torrent Pharma Inc	Class II	24,888 bottles	Terminated
2021-06-02	CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc.	Class II	4 bottles	Terminated
2021-02-17	Failed Impurity/Degradation Specifications SUN PHARMACEUTICAL INDUSTRIES INC	Class III	20,475 vials	Terminated
2018-02-14	Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass AuroMedics Pharma LLC	Class I	66,100 vials	Terminated
2017-03-22	Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. Pfizer Inc.	Class III	582,165 vials	Terminated
2017-02-15	Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. Aurobindo Pharma USA Inc	Class III	29800 vials	Terminated

Pantoprazole Shortages

FDA-listed shortages of pantoprazole products. Strength and dosage-form level detail.

No active or recent shortages of pantoprazole are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated May 28, 2026

Is Pantoprazole Safe?

Pantoprazole is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers presence of gastric (Section 5.1), injection site reactions (Section 5.2), potential for exacerbation of zinc deficiency (Section 5.3), acute tubulointerstitial nephritis (Section 5.4), clostridioides difficile -associated diarrhea (Section 5.5), bone fracture (Section 5.6), severe cutaneous adverse reactions (Section 5.7), cutaneous and systemic lupus erythematosus (Section 5.8), hepatic effects (Section 5.9), hypomagnesemia and mineral metabolism (Section 5.10), fundic gland polyps (Section 5.11), interference with investigations for neuroendocrine tumors (Section 5.12), interference with urine screen for thc (Section 5.13), concomitant use of pantoprazole sodium with methotrexate (Section 5.14).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (pantoprazole label)·Updated May 28, 2026

FDA-Approved Indications

Pantoprazole is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Acid reflux & GI

Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.
Show full Indications and UsageSee less
Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. ( 1 ) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. ( 1 ) Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. ( 1 )

Source: DailyMed (pantoprazole label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of pantoprazole?

Chronic kidney disease, fatigue, and nausea are among the most-reported reactions in FDA FAERS data for pantoprazole. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is pantoprazole the same as Protonix Delayed-Release?

Pantoprazole is the generic name; Protonix Delayed-Release is a brand name for the same active ingredient. Other brand names include Protonix, Protonix I.V., and Protonix Iv. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has pantoprazole been recalled?

Yes. Pantoprazole has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations, contamination or foreign material, and subpotent or out-of-spec content. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are pantoprazole's current ongoing recalls about?

Active pantoprazole recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is CGMP deviations. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.