Side Effects of Aciphex (rabeprazole)

Aciphex, along with antibiotics, eradicates Helicobacter pylori infections and heals stomach and esophageal ulcers by reducing stomach acid secretion.

Common side effects of Aciphex include:

Serious side effects include:

• severe stomach pain,
• watery or bloody diarrhea,
• seizure,
• kidney problems,
• low magnesium, and
• signs of bleeding (in patients who also take warfarin).

Aciphex may interact with warfarin and affect drug absorption of other medications such as ketoconazole and digoxin. It may also decrease blood levels of atazanavir.

Use of Aciphex in pregnant and nursing women should be consulted with a doctor.

What are the important side effects of Aciphex (rabeprazole)?

Rabeprazole has few side effects. The most common side effects are:

Other side effects include:

• dizziness,
• nervousness,
• abnormal heartbeat,
• muscle pain,
• weakness,
• leg cramps, and
• water retention.

Aciphex (rabeprazole) side effects list for healthcare professionals

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Interstitial Nephritis
• Clostridium difficile-Associated Diarrhea
• Bone Fracture
• Cutaneous and Systemic Lupus Erythematosus
• Cyanocobalamin (Vitamin B-12) Deficiency
• Hypomagnesemia

Clinical Studies Experience

Adverse reactions observed in adult patients treated with Aciphex delayed-release tablets include:

An analysis of adverse reactions in controlled trials revealed:

• pain,
• pharyngitis,
• flatulence,
• infection, and
• constipation.

Long-term maintenance studies show adverse reactions such as:

• headache,
• abdominal pain,
• diarrhea,
• dry mouth,
• dizziness,
• peripheral edema,
• hepatic enzyme increase,
• hepatitis,
• hepatic encephalopathy,
• myalgia, and
• arthralgia.

Combination Treatment With Amoxicillin And Clarithromycin

Adverse reactions for patients receiving RAC therapy include diarrhea and taste perversion.

Laboratory abnormalities or adverse reactions specific to drug combinations were not observed.

Pediatrics

In a study of adolescent patients, adverse reactions reported include:

• headache,
• diarrhea,
• nausea,
• vomiting, and
• abdominal pain.

No adverse reactions were reported that were not previously observed in adults.

Postmarketing Experience

The following adverse reactions have been reported post approval:

Blood and Lymphatic System Disorders: agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia

General Disorders and Administration Site Conditions: sudden death

Hepatobiliary Disorders: jaundice

Immune System Disorders: anaphylaxis, angioedema, systemic lupus erythematosus, Stevens-Johnson syndrome, toxic epidermal necrolysis

Infections and Infestations: Clostridium difficile-associated diarrhea

Investigations: Increases in prothrombin time/INR (in patients treated with concomitant warfarin), TSH elevations

Metabolism and Nutrition Disorders: hyperammonemia, hypomagnesemia

Musculoskeletal System Disorders: bone fracture, rhabdomyolysis

Nervous System Disorders: coma

Psychiatric Disorders: delirium, disorientation

Renal and Urinary Disorders: interstitial nephritis

Respiratory, Thoracic and Mediastinal Disorders: interstitial pneumonia

Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions including bullous and other drug eruptions of the skin, cutaneous lupus erythematosus, erythema multiforme

What drugs interact with Aciphex (rabeprazole)?

Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Aciphex delayed-release tablets.

Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 2: Clinically Relevant Interactions Affecting Drugs Co-Administered with Aciphex Delayed-Release Tablets and Interactions with Diagnostics

• Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with rabeprazole may reduce antiviral effect and promote drug resistance.
• Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with rabeprazole may increase toxicity.
• No clinically relevant interactions were observed with other antiretroviral drugs.

Summary

Aciphex (rabeprazole) is a proton pump inhibitor (PPI) used to treat acid-caused conditions such as stomach and duodenal ulcers, GERD, and Zollinger-Ellison Syndrome. Common side effects include diarrhea, nausea, vomiting, constipation, rash, headaches, dizziness, nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps, and water retention. Use of Aciphex in pregnant and nursing women should be consulted with a doctor.