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. In general, rabeprazole treatment has been well-tolerated in both short-term and long-term trials. The adverse events rates were generally similar between the 10 and 20 mg doses.

INCIDENCE IN CONTROLLED NORTH AMERICAN AND EUROPEAN CLINICAL TRIALS

In an analysis of adverse events assessed as possibly or probably related to treatment appearing in greater than 1% of ACIPHEX® patients and appearing with greater frequency than placebo in controlled North American and European trials, the incidence of headache was 2.4% (n=1552) for ACIPHEX® versus 1.6% (n=258) for placebo.

In short and long-term studies, the following adverse events, regardless of causality, were reported in ACIPHEX®treated patients. Rare events are those reported in Body as a Whole: asthenia, fever, allergic reaction, chills, malaise, chest pain substernal, neck rigidity, photosensitivity reaction. Rare: abdomen enlarged, face edema, hangover effect. Cardiovascular System: hypertension, myocardial infarct, electrocardiogram abnormal, migraine, syncope, angina pectoris, bundle branch block, palpitation, sinus bradycardia, tachycardia. Rare: bradycardia, pulmonary embolus, supraventricular tachycardia, thrombophlebitis, vasodilation, QTC prolongation and ventricular tachycardia. Digestive System: 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, esophagitis, glossitis, pancreatitis, proctitis. Rare: bloody diarrhea, cholangitis, duodenitis, gastrointestinal hemorrhage, hepatic encephalopathy, hepatitis, hepatoma, liver fatty deposit, salivary gland enlargement, thirst. Endocrine System: hyperthyroidism, hypothyroidism. Hemic & Lymphatic System: anemia, ecchymosis, lymphadenopathy, hypochromic anemia. Metabolic & Nutritional Disorders: peripheral edema, edema, weight gain, gout, dehydration, weight loss. Musculo-Skeletal System: myalgia, arthritis, leg cramps, bone pain, arthrosis, bursitis. Rare: twitching. Nervous System: insomnia, anxiety, dizziness, depression, nervousness, somnolence, hypertonia, neuralgia, vertigo, convulsion, abnormal dreams, libido decreased, neuropathy, paresthesia, tremor. Rare: agitation, amnesia, confusion, extrapyramidal syndrome, hyperkinesia. Respiratory System: dyspnea, asthma, epistaxis, laryngitis, hiccup, hyperventilation. Rare: apnea, hypoventilation. Skin and Appendages: rash, pruritus, sweating, urticaria, alopecia. Rare: dry skin, herpes zoster, psoriasis, skin discoloration. Special Senses: cataract, amblyopia, glaucoma, dry eyes, abnormal vision, tinnitus, otitis media. Rare: corneal opacity, blurry vision, diplopia, deafness, eye pain, retinal degeneration, strabismus. Urogenital System: cystitis, urinary frequency, dysmenorrhea, dysuria, kidney calculus, metrorrhagia, polyuria. Rare: breast enlargement, hematuria, impotence, leukorrhea, menorrhagia, orchitis, urinary incontinence.

Laboratory Values: The following changes in laboratory parameters were reported as adverse events: abnormal platelets, albuminuria, creatine phosphokinase increased, erythrocytes abnormal, hypercholesteremia, hyperglycemia, hyperlipemia, hypokalemia, hyponatremia, leukocytosis, leukorrhea, liver function tests abnormal, prostatic specific antigen increase, SGPT increased, urine abnormality, WBC abnormal.

In controlled clinical studies, 3/1456 (0.2%) patients treated with rabeprazole and 2/237 (0.8%) patients treated with placebo developed treatment-emergent abnormalities (which were either new on study or present at study entry with an increase of 1.25 × baseline value) in SGOT (AST), SGPT (ALT), or both. None of the three rabeprazole patients experienced chills, fever, right upper quadrant pain, nausea or jaundice.

Combination Treatment with Amoxicillin and Clarithromycin: In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse events unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse events 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 events or laboratory changes with amoxicillin or clarithromycin, refer to their respective package prescribing information, ADVERSE REACTIONS section.

Post-Marketing Adverse Events: Additional adverse events reported from worldwide marketing experience with rabeprazole sodium are: sudden death; coma and 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; and TSH elevations. In most instances, the relationship to rabeprazole sodium was unclear. 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

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