Pantoprazole Sodium

More frequently reported side effects include: diarrhea and nausea. See below for a comprehensive list of adverse effects.

Applies to pantoprazole: oral packet, oral tablet enteric coated

Other dosage forms:

• intravenous powder for solution

Along with its needed effects, pantoprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pantoprazole:

Less common

• Blurred vision
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• nausea
• stomach pain
• sweating
• troubled breathing
• unexplained weight loss
• vomiting

Incidence not known

• Absence of or decrease in body movements
• blindness
• blistering, peeling, or loosening of the skin
• bloating
• bloody or cloudy urine
• bloody, black, or tarry stools
• blurred vision
• chills
• clay-colored stools
• constipation
• continuous ringing or buzzing or other unexplained noise in the ears
• cough
• dark urine
• decreased vision
• diarrhea
• difficulty with speaking
• difficulty with swallowing
• dizziness or lightheadedness
• drowsiness
• fast heartbeat
• feeling of constant movement of self or surroundings
• fever
• general feeling of tiredness or weakness
• greatly decreased frequency of urination or amount of urine
• headache
• hearing loss
• high fever
• hives, itching, or skin rash
• indigestion
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• light-colored stools
• loss of appetite
• mood or mental changes
• muscle cramp, pain, or stiffness
• muscle spasms (tetany) or twitching
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sensation of spinning
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• swelling of the feet or lower legs
• swollen glands
• tightness in the chest
• trembling
• unexplained bleeding or bruising
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Some Side Effects Of Pantoprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Belching
• bloated or full feeling
• excess air or gas in the stomach or bowels
• passing gas
• trouble sleeping

Incidence not known

• Increased watering of the mouth

Applies to pantoprazole: intravenous powder for injection, oral delayed release tablet, oral granule enteric coated

The most commonly reported side effects were headache, diarrhea, and injection site thrombophlebitis (in IV formulations).

Very common (10% or more): Headache (Up to 26.4%), taste pervasion (Up to 18.2%)

Common (1% to 10%): Dizziness, metallic/bitter taste, somnolence

Rare (0.01% to 0.1%): Taste disorders

Very rare (less than 0.01%): Change to the sense of taste, reduced movement, speech disorder

Frequency not reported: Paresthesia, vertigo

Postmarketing reports: Ageusia, dysgeusia

Headache was a very commonly reported side effect in pediatric patients 2 to 16 years of age. In adults, headache occurred most frequently in patients given quadruple therapy (pantoprazole, bismuth, metronidazole, tetracycline) for H pylori infections, but was also very common in triple therapy (pantoprazole, amoxicillin, clarithromycin).

Taste pervasion most frequently occurred in patients given triple therapy, but it was also very common in patients given quadruple therapy.

Very common (10% or more): Nasopharyngitis (up to 13.6%), pharyngolaryngeal pain (up to 13.2%)

Common (1% to 10%): Cough, nasal congestion, pharyngitis

Very rare (less than 0.01%): Change to the sense of smell, dyspnea

Frequency not reported: Upper respiratory tract infection

Nasopharyngitis and pharyngolaryngeal pain occurred in pediatric patients between the ages of 2 to 16 years.

Diarrhea occurred most frequently in patients given quadruple therapy (pantoprazole, bismuth, metronidazole, tetracycline) for Helicobacter pylori infections, but was also very common in triple therapy (pantoprazole, amoxicillin, clarithromycin).

Nausea, vomiting, abdominal pain, dry mouth, and constipation were more commonly reported in patients given triple therapy, compared to patients given quadruple therapy.

Fecal and/or tongue discoloration occurred more commonly in patients given quadruple therapy versus patients given triple therapy.

Very common (10% or more): Diarrhea (Up to 11.6%)

Common (1% to 10%): Abdominal pain, benign fundic gland polyps/fundic gland polyps, buccal inflammation, constipation, dry mouth, dyspepsia, fecal discoloration, flatulence, heartburn, nausea, oral moniliasis, pruritus ani, tongue discoloration, tongue pain, upper abdominal pain, vomiting

Uncommon (0.1% to 1%): Abdominal discomfort/distention, bloating, loose stools

Rare (0.01% to 0.1%): Colon polyp, rectal disorder

Very rare (less than 0.01%): Increased saliva

Frequency not reported: Clostridium difficile-associated diarrhea, severe eructation

Common (1% to 10%): Tiredness

Uncommon (0.1% to 1%): Asthenia, fatigue, malaise

Rare (0.01% to 0.1%): Body temperature increased, fever

Very rare (less than 0.01%): Pain, tinnitus

Frequency not reported: Facial edema

Confusion, depression, hallucinations, and disorientation, especially in predisposed patients, occurred with use, and was aggravated in patients with preexisting conditions.

Common (1% to 10%): Depression (and all aggravations)

Uncommon (0.1% to 1%): Sleep disorders

Rare (0.01% to 0.1%): Confusion (and all aggravations), disorientation (and all aggravations), hallucination (and all aggravations)

Very rare (less than 0.01%): Anxiety

Postmarketing reports: Insomnia

Severe hepatocellular damage leading to jaundice/hepatic failure is predicted to have a frequency of 1 in 1,000,000 patients.

Common (1% to 10%): Increased liver enzymes (transaminases, GGT)

Rare (0.01% to 0.1%): Increased bilirubin

Very rare (less than 0.01%): Cholestatic hepatitis, hepatitis, hepatocellular failure, jaundice

Frequency not reported: Hepatic effects, hepatocellular injury, liver function tests abnormal

Postmarketing reports: Hepatocellular damage

Common (1% to 10%): Exanthema/exanthemata, rash

Uncommon (0.1% to 1%): Eruption, increased sweating, pruritus

Rare (0.01% to 0.1%): Urticaria

Very rare (less than 0.01%): Erythema multiforme, flushing, Lyell syndrome, photosensitivity/photosensitivity reaction, severe skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)

Frequency not reported: Cutaneous lupus erythematosus, facial edema, fatal skin reactions, fatal TEN, subacute cutaneous lupus erythematosus

Common (1% to 10%): Chest pain

Rare (0.01% to 0.1%): Hypertension, peripheral edema, thrombophlebitis

Very rare (less than 0.01%): Circulatory collapse, flushing, hot flushes, substernal chest pain

Frequency not reported: Generalized edema

Muscle spasm occurred as a consequence of electrolyte disturbances.

Common (1% to 10%): Arthralgia

Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine

Rare (0.01% to 0.1%): Myalgia

Very rare (less than 0.01%): Skeletal pain

Frequency not reported: Bone fracture, elevated creatine phosphokinase (CPK)/elevated creatine kinase (CK), muscle spasm, systemic lupus erythematosus

Postmarketing reports: Rhabdomyolysis

Hypocalcemia occurred in association with hypomagnesemia.

Anorexia commonly occurred in patients with H pylori.

Common (1% to 10%): Anorexia

Rare (0.01% to 0.1%): Hyperlipidemia, increased cholesterol, increased triglycerides, lipid increases, weight changes

Frequency not reported: Cyanocobalamin (vitamin B12) deficiency), electrolyte disturbances, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, potential for exacerbation of zinc deficiency

Common (1% to 10%): Injection site thrombophlebitis

Frequency not reported: Injection site reactions

Common (1% to 10%): Influenza-like symptoms, moniliasis

Rare (0.01% to 0.1%): Sepsis

Rare (0.01% to 0.1%): Anaphylactic reactions, anaphylactic shock, angioedema/Quincke's edema, hypersensitivity, hypersensitivity reactions

Frequency not reported: Allergic reactions

Postmarketing reports: Anaphylaxis

Rare (0.01% to 0.1%): Agranulocytosis, anemia

Very rare (less than 0.01%): Increased coagulation time, leukopenia, pancytopenia, thrombocytopenia

Uncommon (0.1% to 1%): Blurred vision, visual disturbances

Very rare (less than 0.01%): Conjunctivitis

Rare (0.01% to 0.1%): Gynecomastia

Very rare (less than 0.01%): Interstitial nephritis (with possible progression to renal failure)

Frequency not reported: Acute interstitial nephritis