Rabeprazole Side Effects

Brand Names: AcipHex, Aciphex

Please note - some side effects for Rabeprazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rabeprazole - for the Consumer

Rabeprazole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rabeprazole:

Diarrhea; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; unusual bruising or bleeding; unusual tiredness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Side Effects by Body System

General

Rabeprazole is generally well tolerated. The adverse event rates were generally similar between the 10 and 20 mg doses.

Oncologic

Any drug which increases gastric pH would be anticipated to stimulate release of gastrin. Animal studies have demonstrated an increase in plasma gastrin concentrations following the administration of rabeprazole. In addition, lifelong high-dose animal studies have revealed a dose-related increase in the incidence of gastric enterochromaffin-like (ECL) cell carcinoids (especially in female rats). However, to date, human studies of up to 1 year have not found any suggestion of gastric carcinoid formation due to rabeprazole use.

Oncologic side effects have not been reported.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, abdominal pain, vomiting, dyspepsia, flatulence, constipation, dry mouth, eructation, gastroenteritis, rectal hemorrhage, melena, anorexia, cholelithiasis, mouth ulceration, stomatitis, dysphagia, gingivitis, cholecystitis, increased appetite, abnormal stools, colitis, and esophagitis. Rarely, cholangitis, duodenitis, salivary gland enlargement, and thirst have also been reported.

Nervous system

Nervous system side effects have included headache (2.4%), insomnia, anxiety, dizziness, depression, nervousness, somnolence, hypertonia, neuralgia, vertigo, convulsion, abnormal dreams, decreased libido, neuropathy, and tremor. Agitation, amnesia, confusion, extrapyramidal syndrome, and hyperkinesia have rarely been reported. Hand and facial numbness have also been reported.

Endocrine

Endocrine side effects have included gynecomastia, breast enlargement in females, and breast tenderness.

Dermatologic

Dermatologic side effects have included rash, pruritus, sweating, urticaria, photosensitivity, and alopecia. Rare reports of dry skin, psoriasis, and skin discoloration have also been reported.

Hepatic

Hepatic side effects have included rare cases of hepatic encephalopathy, hepatitis, hepatoma, and fatty deposits in liver.

Respiratory

Respiratory side effects have included dyspnea, asthma, epistaxis, laryngitis, hiccup, and hyperventilation. Rare reports of apnea and hypoventilation have also been reported.

Genitourinary

Genitourinary side effects have included cystitis, urinary frequency, dysmenorrhea, and dysuria. Rare reports of impotence, hematuria, orchitis, and urinary incontinence have also been reported.

Cardiovascular

Cardiovascular side effects have included rare reports of angina, tachycardia, sinus bradycardia, palpitations, hypertension, myocardial infarction, syncope, angina pectoris, bundle branch block, palpitations, supraventricular tachycardia, and peripheral edema. Electrocardiogram abnormalities have also been reported.

Hematologic

Hematologic side effects have included rare reports of anemia, ecchymosis, lymphadenopathy, and hypochromic anemia.

Hypersensitivity

Hypersensitivity side effects have included fever, allergic reaction, chills, malaise, and face edema.

Metabolic

Metabolic side effects have included weight gain, gout, dehydration, and weight loss.

Musculoskeletal

An increased risk of hip fracture has been reported. This risk is significantly increased among patients prescribed long-term high dose PPIs.

Musculoskeletal side effects have included myalgia, arthritis, leg cramps, bone pain, arthrosis, bursitis, and rarely rhabdomyolysis. Hip fracture and muscle stiffness have also been reported.

Ocular

Ocular side effects have included cataract, amblyopia, glaucoma, dry eyes, and abnormal vision. Cornea opacity, blurry vision, diplopia, eye pain, and retinal degeneration have been reported rarely. Ocular lesions have also been reported.

Psychiatric

A 55-year-old female with dyspepsia experienced marked anxiety associated with panic attacks, night terror (pavor nocturnus), episodic mental confusion, and attention deficit coincident with rabeprazole therapy. She presented with the neuropsychiatric manifestations 10 days after being administered rabeprazole 20 mg per day. Within two days of discontinuing rabeprazole, she recovered completely.

Psychiatric side effects have included insomnia, anxiety, depression, nervousness, somnolence, abnormal dreams, decreased libido, agitation, amnesia, confusion, and panic reaction. A least one case of marked anxiety associated with panic attacks, night terror (pavor nocturnus), episodic mental confusion, and attention deficit has been reported.

Renal

A 57-year-old male with diverticulosis, esophageal reflux due to diaphragmatic hernia, and eczema experienced interstitial nephritis coincident with rabeprazole therapy. He was administered rabeprazole 20 mg daily for esophagitis. Renal biopsy revealed interstitial nephritis with unspecified glomerular sclerosis with predominantly interstitial changes. His condition improved when rabeprazole was withdrawn.

Renal side effects have included at least one case of interstitial nephritis.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.