Side effects of aciphex

Aciphex

SIDE EFFECTS

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

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The data described below reflect exposure to ACIPHEX delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. The studies were primarily placebo- and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers. The population had a mean age of 53 years (range 18-89 years) and had a ratio of approximately 60% male: 40% female. The racial distribution was 86% Caucasian, 8% African American, 2% Asian, and 5% other. Most patients received either 10 mg, 20 mg or 40 mg per day of ACIPHEX delayed-release tablets.

Three long-term maintenance studies consisted of a total of 740 adult patients; at least 54% of adult patients were exposed to ACIPHEX delayed-release tablets for 6 months and at least 33% were exposed for 12 months. Of the 740 adult patients, 247 (33%) and 241 (33%) patients received 10 mg and 20 mg of ACIPHEX delayed-release tablets, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole.

The safety profile of rabeprazole in the maintenance studies in adults was consistent with what was observed in the acute studies.

Less common adverse reactions seen in controlled clinical trials (<2% of patients treated with ACIPHEX delayed-release tablets and greater than placebo) and for which there is a possibility of a causal relationship to rabeprazole, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.

Combination Treatment With Amoxicillin And Clarithromycin

In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse reactions unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse reactions for patients who received RAC therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively.

No clinically significant laboratory abnormalities particular to the drug combinations were observed.

For more information on adverse reactions or laboratory changes with amoxicillin or clarithromycin, refer to their respective prescribing information, Adverse Reactions section.

Pediatrics

In a multicenter, open-label study of adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults. The adverse reactions reported without regard to relationship to ACIPHEX delayed-release tablets that occurred in ≥2% of 111 patients were headache (9.9%), diarrhea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%). The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in this study that were not previously observed in adults.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of rabeprazole. 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:

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

Ear and Labyrinth Disorders: vertigo

Eye Disorders: blurred vision

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 (some fatal)

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

Read the entire FDA prescribing information for Aciphex (Rabeprazole Sodium)

AcipHex

Generic Name: rabeprazole (ra BEP ra zole)
Brand Names: AcipHex, AcipHex Sprinkle

Medically reviewed by Sophia Entringer, PharmD Last updated on Jun 11, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is AcipHex?

AcipHex (rabeprazole) is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

AcipHex is used short-term to treat symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1 year old.

AcipHex is used only in adults to treat conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome. It is also used in adults to promote healing of duodenal ulcers or erosive esophagitis (damage to your esophagus caused by stomach acid).

AcipHex may also be given with an antibiotic to prevent duodenal ulcer caused by infection with Helicobacter pylori (H. pylori).

AcipHex is not for immediate relief of heartburn symptoms.

You should not use AcipHex if you are allergic to rabeprazole or to similar medicines such as lansoprazole (Prevacid), esomeprazole (Nexium), omeprazole (Prilosec, Zegerid), or pantoprazole (Protonix). AcipHex is not for immediate relief of heartburn symptoms.

Rabeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

AcipHex may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

Taking AcipHex may increase your risk of bone fracture in the hip, wrist, or spine, especially if you take the medicine long term or more than once per day.

How should I take AcipHex?

AcipHex is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

AcipHex is for short-term use only, usually 4 to 8 weeks. Your doctor may recommend a second course of treatment if you need additional healing time.

AcipHex Sprinkle should not be given to a child younger than 1 year old.

Take this medicine with a full glass of water.

If you take AcipHex to treat duodenal ulcers, take the medicine after a meal. If you take AcipHex to prevent ulcers caused by Helicobacter pylori, take the medicine with food. If you take this medicine for any other condition, you may take it with or without food.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Swallow the tablet whole and do not crush, chew, or break it.

Do not swallow a delayed-release capsule (AcipHex Sprinkle) whole. Open it and sprinkle the medicine into a spoonful of soft food such as applesauce, yogurt, or baby food made from fruit or vegetable. You may also mix the medicine with apple juice, Pedialyte, or infant formula. Swallow the mixture right away without chewing. Do not save it for later use.

Rabeprazole can affect the results of certain medical tests. Tell any doctor who treats you that you are using rabeprazole.

Some conditions are treated with a combination of rabeprazole and antibiotics. Use all medications as directed.

Take AcipHex for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve, or if they get worse while using AcipHex.

Store at room temperature away from moisture and heat.

AcipHex Dosing Information

Usual Adult Dose for Duodenal Ulcer:

20 mg orally once a day
-Duration of therapy: 4 weeks
Comment: While most patients achieve ulcer healing after 4 weeks, some patients may need an additional course of therapy to achieve ulcer healing.
Use: Healing and symptomatic relief of duodenal ulcers

Usual Adult Dose for Erosive Esophagitis:

20 mg orally once a day
-Duration of therapy: 4 to 8 weeks
Comment: If patients are not healed after 8 weeks, treatment for another 8 weeks may be considered.
Use: Short-term treatment for healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD)

Usual Adult Dose for Gastric Ulcer:

20 mg orally once a day
-Duration of therapy: 4 to 8 weeks
Comment: If patients are not healed after 8 weeks, treatment for another 8 weeks may be considered.
Use: Short-term treatment for healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD)

Usual Adult Dose for Duodenal Ulcer Prophylaxis:

20 mg orally once a day
-Duration of therapy: Up to 12 months
Comment: Controlled studies for maintenance therapy have not extended beyond 12 months.
Use: Maintenance of healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative GERD

Usual Adult Dose for Gastroesophageal Reflux Disease:

20 mg orally once a day
-Duration of therapy: Up to 4 weeks
Comment: If symptoms do not resolve after 4 weeks of therapy, an additional course of treatment may be considered.
Use: Treatment of daytime and nighttime heartburn and other symptoms associated with GERD

Usual Adult Dose for Helicobacter pylori Infection:

20 mg orally 2 times a day, taken concomitantly with amoxicillin and clarithromycin
-Duration of therapy: 7 days

-Refer to the manufacturer product information for dosing for amoxicillin and clarithromycin.
-All medications should be taken with morning and evening meals.
-Eradication of Helicobacter pylori has been shown to decrease the risk of duodenal ulcer recurrence.
-Patients who fail therapy should undergo susceptibility testing and/or begin alternative antimicrobial therapy.
Use: Treatment and eradication of H pylori and active/history of duodenal ulcer disease within 5 years

Usual Adult Dose for Zollinger-Ellison Syndrome:

Initial dose: 60 mg orally once a day
Maintenance dose: 60 mg orally 2 times a day or 100 mg orally once a day
Duration of therapy: Up to 1 year

-Doses should be patient-specific and should continue for as long as clinically necessary.
-Divided dosing may be required in some patients.
Use: Long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome)

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

1 to 11 years:
Less than 15 kg: 5 mg orally once a day, with the option to increase to 10 mg if inadequate response
15 kg or more: 10 mg orally once a day
Duration of therapy: Up to 12 weeks
12 years or older: 20 mg orally once a day
-Duration of therapy: Up to 8 weeks
Uses:
-Treatment of GERD
-Treatment of symptomatic GERD

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking AcipHex?

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

What other drugs will affect AcipHex?

Tell your doctor about all your current medicines. Many drugs can interact with rabeprazole, especially:

  • digoxin;

  • methotrexate; or

  • warfarin (Coumadin, Jantoven).

This list is not complete and many other drugs may interact with rabeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

More about Aciphex (rabeprazole)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Español
  • 51 Reviews
  • Generic Availability
  • Drug class: proton pump inhibitors
  • FDA Alerts (3)
  • Aciphex (Rabeprazole Delayed-Release Tablets)
  • Aciphex (Rabeprazole Sprinkle Capsules)
  • Aciphex (Advanced Reading)

Other brands: Aciphex Sprinkle

  • AcipHex (AHFS Monograph)
  • … +1 more
  • Barrett’s Esophagus
  • Duodenal Ulcer
  • Duodenal Ulcer Prophylaxis
  • Erosive Esophagitis
  • … +4 more

rabeprazole (AcipHex, AcipHex Sprinkle)

Brand Names: AcipHex, AcipHex Sprinkle

Generic Name: rabeprazole

  • What is rabeprazole (AcipHex, AcipHex Sprinkle)?
  • What are the possible side effects of rabeprazole (AcipHex, AcipHex Sprinkle)?
  • What is the most important information I should know about rabeprazole (AcipHex, AcipHex Sprinkle)?
  • What should I discuss with my healthcare provider before taking rabeprazole (AcipHex, AcipHex Sprinkle)?
  • How should I take rabeprazole (AcipHex, AcipHex Sprinkle)?
  • What happens if I miss a dose (AcipHex, AcipHex Sprinkle)?
  • What happens if I overdose (AcipHex, AcipHex Sprinkle)?
  • What should I avoid while taking rabeprazole (AcipHex, AcipHex Sprinkle)?
  • What other drugs will affect rabeprazole (AcipHex, AcipHex Sprinkle)?
  • Where can I get more information (AcipHex, AcipHex Sprinkle)?

What is rabeprazole (AcipHex, AcipHex Sprinkle)?

Rabeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Rabeprazole is used short-term to treat symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1 year old.

Rabeprazole is used only in adults to treat conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome. Rabeprazole is also used in adults to promote healing of duodenal ulcers or erosive esophagitis (damage to your esophagus caused by stomach acid).

Rabeprazole may also be given with an antibiotic to prevent duodenal ulcer caused by infection with Helicobacter pylori (H. pylori).

Rabeprazole is not for immediate relief of heartburn symptoms.

Rabeprazole may also be used for purposes not listed in this medication guide.

000930064_PB

round, yellow, imprinted with 93 64

003786709_PB

round, beige, imprinted with M R7

136680107_PB

round, yellow, imprinted with 107

422910721_PB

round, yellow, imprinted with 93 64

621750302_PB

round, blue, imprinted with KU, 7

628560243_PB

round, yellow, imprinted with ACIPHEX 20

Aciphex 20 mg

round, yellow, imprinted with ACIPHEX 20

Aciphex 20 mg

round, yellow, imprinted with E243

What are the possible side effects of rabeprazole (AcipHex, AcipHex Sprinkle)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • sudden pain or trouble moving your hip, wrist, or back;
  • seizure (convulsions);
  • kidney problems–urinating less than usual, blood in your urine, swelling, rapid weight gain;
  • new or worsening symptoms of lupus–joint pain, and a skin rash on your cheeks or arms that worsens in sunlight;
  • low magnesium–dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
  • signs of bleeding (if you also take warfarin)–headaches, dizziness, weakness; pain or swelling; bruising, unusual bleeding (nosebleeds, bleeding gums); red or pink urine; heavy menstrual flow; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or any bleeding that will not stop.

Taking rabeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use rabeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

  • headache;
  • nausea, vomiting;
  • diarrhea, constipation; or
  • stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rabeprazole (AcipHex, AcipHex Sprinkle)?

Rabeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Rabeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *