Rabeprazole Sodium

Commonly reported side effects of rabeprazole include: atrophic gastritis. See below for a comprehensive list of adverse effects.

Applies to rabeprazole: oral capsule delayed release, oral tablet enteric coated

Along with its needed effects, rabeprazole 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 rabeprazole:

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chills
• cough
• dark urine
• dry mouth
• fever
• general feeling of tiredness and weakness
• hoarseness
• light-colored stools
• lower back or side pain
• nausea
• painful or difficult urination
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss
• vomiting
• yellow eyes and skin

Rare

• Bloody urine
• continuing ulcers or sores in the mouth
• difficulty with breathing
• seizures
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Back, leg, or stomach pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• bloody, black, or tarry stools
• change in consciousness
• clay-colored stools
• cloudy urine
• confusion about identity, place, person, and time
• continuing nausea or vomiting
• difficulty with swallowing
• dizziness
• drowsiness
• fast heartbeat
• general body swelling
• greatly decreased frequency of urination or amount of urine
• headache
• high fever
• hives, itching, or skin rash
• holding false beliefs that cannot be changed by fact
• increase in the frequency of seizures
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of appetite
• loss of consciousness
• mood or mental changes
• muscle cramp, pain, or stiffness
• muscle spasms (tetany) or twitching
• no blood pressure
• no breathing
• no pulse
• nosebleeds
• pale skin
• pinpoint red spots on the 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
• seeing, hearing, or feeling things that are not there
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• tightness in the chest
• trembling
• unpleasant breath odor
• unusual excitement, nervousness, or restlessness
• vomiting of blood

Some side effects of rabeprazole 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:

More common

• Bad, unusual, or unpleasant (after) taste
• change in taste

Less common

• Body aches or pain
• congestion
• constipation
• diarrhea
• excess air or gas in the stomach or bowels
• full feeling
• heartburn
• numbness, tingling, pain, or weakness in the hands or feet
• passing gas
• runny nose
• sleepiness
• swollen joints
• tender, swollen glands in the neck
• voice changes

Applies to rabeprazole: oral delayed release capsule, oral delayed release tablet, oral tablet extended release

The most commonly reported side effects are headache, diarrhea, and abdominal pain.

Very common (10% or more): Diarrhea (up to 21%), abdominal pain (up to 16%), vomiting (up to 14%)

Common (1% to 10%): Benign fundic gland polyps, constipation, flatulence, nausea

Uncommon (0.1% to 1%): Dry mouth, dyspepsia, eructation

Rare (0.01% to 0.1%): Gastritis, stomatitis

Frequency not reported: Microscopic colitis

Postmarketing reports: Clostridium difficile-associated diarrhea

Common (1% to 10%): Asthenia, non-specific pain, pain

Uncommon (0.1% to 1%): Chills, pyrexia/fever

Postmarketing reports: Sudden death

Common (1% to 10%): Cough, pharyngitis, rhinitis

Uncommon (0.1% to 1%): Bronchitis, sinusitis

Postmarketing reports: Dyspnea, interstitial pneumonia

Common (1% to 10%): Dizziness, headache, taste disturbance/perversion

Uncommon (0.1% to 1%): Somnolence

Rare (0.01% to 0.1%): Hepatic encephalopathy

Postmarketing reports: Coma, vertigo

Hepatic encephalopathy occurred in patients with underlying cirrhosis.

Common (1% to 10%): Flu-like syndrome/ influenza-like illness, infection

Common (1% to 10%): Back pain, myalgia

Uncommon (0.1% to 1%): Arthralgia, fracture of hip/wrist/spine, leg cramps

Postmarketing reports: Bone fractures, rhabdomyolysis

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Erythema

Rare (0.01% to 0.1%): Bullous reactions, pruritus, sweating

Very rare (less than 0.01%): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)

Frequency not reported: Facial swelling, subacute cutaneous lupus erythematosus

Postmarketing reports: fatal TEN, other drug eruptions, severe dermatological reactions, systemic lupus erythematosus, urticarial skin eruptions

Erythema and bullous reactions usually resolved after discontinuation.

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Nervousness

Rare (0.01% to 0.1%): Depression

Frequency not reported: Confusion

Postmarketing reports: Delirium, disorientation

Common (1% to 10%): Chest pain

Uncommon (0.1% to 1%): Peripheral edema

Postmarketing reports: Hypotension

Uncommon (0.1% to 1%): Increased hepatic enzymes

Rare (0.01% to 0.1%): Hepatitis, jaundice, serious hepatic dysfunction

Increased hepatic enzymes occurred in patients with underlying cirrhosis.

Uncommon (0.1% to 1%): Urinary tract infection

Rare (0.01% to 0.1%): Leukocytosis, leukopenia, neutropenia, thrombocytopenia

Postmarketing reports: Agranulocytosis, bicytopenia, blood dyscrasias, hemolytic anemia, increase in prothrombin time/INR, pancytopenia

Increased prothrombin time/INR occurred in patients taking warfarin concomitantly.

Rare (0.01% to 0.1%): Anorexia, weight gain

Frequency not reported: Cyanocobalamin (Vitamin B-12) deficiency, hypomagnesemia, hyponatremia

Postmarketing reports: Hyperammonemia

Rare (0.01% to 0.1%): Interstitial nephritis

Rare (0.01% to 0.1%): Visual disturbance

Postmarketing reports: Blurred vision

Frequency not reported: Gynecomastia

Postmarketing reports: Thyroid stimulating hormone (TSH) elevations

Hypersensitivity reactions included facial swelling, hypotension, dyspnea, erythema, and bullous reactions; these reactions typically resolved after discontinuation.

Rare (0.01% to 0.1%): Hypersensitivity

Postmarketing reports: Acute systemic allergic reactions, anaphylaxis/anaphylactic reactions, angioedema, potential allergic reactions