(pantoprazole sodium for injection)
The following serious adverse reactions are described below and elsewhere in labeling:
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)
Adults
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 PPI, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 2.
The number of patients treated in comparative studies with PROTONIX I.V. 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 PROTONIX I.V.
| Oral Pantoprazole Sodium (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 oral pantoprazole sodium 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 (intravenous 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
Pediatrics
Adverse reactions reported with single and multiple doses of PROTONIX I.V. in 18 hospitalized pediatric patients 1 to 16 years of age were generally similar to those reported in adults treated with intravenous or oral pantoprazole sodium and in pediatric patients treated with oral pantoprazole sodium in clinical trials. Additionally, upper respiratory tract infections in pediatric patients less than 16 years of age and otitis media in pediatric patients less than 1 year of age were reported with oral pantoprazole sodium.
Zollinger-Ellison (ZE) Syndrome
In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered PROTONIX I.V. doses of 80 mg to 240 mg per day for up to 2 years were similar to those reported in adult patients with GERD.
The following adverse reactions have been identified during post approval use of pantoprazole sodium products. 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), systemic lupus erythematosus
Investigations: weight changes
Skin and subcutaneous tissue disorders: severe dermatologic reactions (some fatal), including erythema multiforme, SJS/TEN, DRESS, AGEP, angioedema (Quincke's edema) and cutaneous lupus erythematosus
Musculoskeletal disorders: rhabdomyolysis, bone fracture
Renal and genitourinary disorders: acute tubulointerstitial nephritis, erectile dysfunction
Hepatobiliary disorders: hepatocellular damage leading to jaundice and hepatic failure
Psychiatric disorder: hallucinations, confusion, insomnia, somnolence
Metabolism and nutritional disorders: hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia
Infections and infestations: Clostridioides difficile-associated diarrhea
Hematologic: pancytopenia, agranulocytosis
Nervous: ageusia, dysgeusia
Gastrointestinal disorders: fundic gland polyps
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