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PANTOPRAZOLE SODIUM
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Postmarketing Experience
- The following adverse reactions have been identified during postapproval use of pantoprazole sodium delayed-release tablets. 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, and toxic epidermal necrolysis (TEN, some fatal), and angioedema (Quincke's edema) and cutaneous lupus erythematosus
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
54
42858
Other ADRs
11319
14105960
Odds Ratio = 1.571
Drug Property Information
ATC Code(s):
- A02BC02 - pantoprazole sodium
- A02BC - Proton pump inhibitors
- A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- A02 - DRUGS FOR ACID RELATED DISORDERS
- A - ALIMENTARY TRACT AND METABOLISM
- A02BD04 - pantoprazole sodium
- A02BD - Combinations for eradication of Helicobacter pylori
- A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- A02 - DRUGS FOR ACID RELATED DISORDERS
- A - ALIMENTARY TRACT AND METABOLISM
- A02BD11 - pantoprazole sodium
- A02BD - Combinations for eradication of Helicobacter pylori
- A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- A02 - DRUGS FOR ACID RELATED DISORDERS
- A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:pantoprazole sodium
Active Ingredient UNII:6871619Q5X
Drugbank ID:DB00213
PubChem Compound:4679
CAS Number:102625-70-7
Dosage Form(s):tablet, delayed release
Route(s) Of Administrator:oral
Daily Dose:
- 40.0 mg/day A02BC02
Chemical Structure: 
SMILE Code:
COC1=C(C(=NC=C1)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC(F)F)OC
COC1=C(C(=NC=C1)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC(F)F)OC
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
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