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Aciphex (Rabeprazole Sodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Worldwide, over 2900 patients have been treated with rabeprazole in Phase II-III clinical trials involving various dosages and durations of treatment.

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.

Clinical Studies Experience

The data described below reflect exposure to ACIPHEX in 1064 patients exposed for up to 8 weeks. The studies were primarily placebo- and active-controlled trials in 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/day of ACIPHEX.

An analysis of adverse reactions appearing in ≥ 2% of ACIPHEX patients (n=1064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs. 1%), pharyngitis (3% vs. 2%), flatulence (3% vs. 1%), infection (2% vs. 1%), and constipation (2% vs. 1%).

The 3 long-term maintenance studies consisted of a total of 740 patients; at least 54% of patients were exposed to rabeprazole for 6 months while at least 33% were exposed for 12 months. Of the 740 patients, 247 (33%) and 241 (33%) patients received 10 mg and 20 mg of ACIPHEX, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole.

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

Other adverse reactions that were seen in controlled clinical trials which do not meet the above criteria (≥ 2% of ACIPHEX treated patients and > 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.

In a multicenter, open-label study of adolescent patients aged 12 to 16 years 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 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 these studies that were not previously observed in adults.

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 package prescribing information, ADVERSE REACTIONS section.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ACIPHEX. 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: sudden death; coma, hyperammonemia; jaundice; rhabdomyolysis; disorientation and delirium; anaphylaxis; angioedema; bullous and other drug eruptions of the skin; severe dermatologic reactions, including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; interstitial pneumonia; interstitial nephritis; TSH elevations; bone fractures, hypomagnesemia and Clostridium difficile associated diarrhea. In addition, agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, and thrombocytopenia have been reported. Increases in prothrombin time/INR in patients treated with concomitant warfarin have been reported.



REPORTS OF SUSPECTED ACIPHEX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Aciphex. The information is not vetted and should not be considered as verified clinical evidence.

Possible Aciphex side effects / adverse reactions in 42 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-12

Patient: 42 year old female weighing 112.1 kg (246.6 pounds)

Reactions: Pancreatitis Acute, Ovarian Cyst, Peripheral Sensory Neuropathy, Hepatic Steatosis, Myalgia, Nephrolithiasis, Diverticulum, Uterine Leiomyoma, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Sunitinib Malate,sorafenib,placebo (Code NOT Broken)
    Administration route: Oral
    Indication: Renal Cancer
    Start date: 2008-11-13

Sunitinib Malate,sorafenib,placebo (Code NOT Broken)
    Administration route: Oral
    Indication: Renal Cell Carcinoma
    Start date: 2008-11-13

Prilosec
    Administration route: Oral

Aciphex



Possible Aciphex side effects / adverse reactions in 42 year old female

Reported by a physician on 2011-10-18

Patient: 42 year old female weighing 112.0 kg (246.4 pounds)

Reactions: Myalgia, Blood Amylase Increased, Pancreatitis, Lipase Increased, Hypertension, Peripheral Sensory Neuropathy

Adverse event resulted in: hospitalization

Suspect drug(s):
Prilosec
    Dosage: unknown

Aciphex
    Dosage: unknown
    Administration route: Oral

Sunitinib Malate
    Dosage: unknown
    Administration route: Oral
    Start date: 2008-11-12

Sorafenib
    Dosage: unknown
    Administration route: Oral
    Start date: 2008-11-13



Possible Aciphex side effects / adverse reactions in 64 year old male

Reported by a pharmacist from Japan on 2011-10-21

Patient: 64 year old male

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Amoxicillin
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-02-04
    End date: 2011-02-10

Aciphex
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-02-04
    End date: 2011-02-10

Celecoxib
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2011-06-17

Loxonin
    Dosage: unknown
    Administration route: Oral
    End date: 2011-06-01

Famotidine
    Dosage: unknown
    Administration route: Oral
    Start date: 2008-01-01

Celecoxib
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-05-07
    End date: 2011-05-13

Other drugs received by patient: Troxsin; Clarithromycin; Pravastatin Sodium



See index of all Aciphex side effect reports >>

Drug label data at the top of this Page last updated: 2013-11-11

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