Aciphex Side Effects
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Aciphex Side Effects
Worldwide, over 2900 patients have been treated with Aciphex 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 TM 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 ACIPHEXTM 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 ≤1/1000 patients.
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:
Musculo-Skeletal System:
- myalgia
- arthritis
- leg cramps
- bone pain
- arthrosis
- bursitis
Musculo-Skeletal System (rare):
- twitching
Nervous System:
- insomnia
- anxiety
- dizziness
- depression
- nervousness
- somnolence
- hypertonia
- neuralgia
- vertigo
- convulsion
- abnormal dreams
- libido decreased
- neuropathy
- paresthesia
- tremor
Nervous System (rare):
- agitation
- amnesia
- confusion
- extrapyramidal syndrome
- hyperkinesia
Respiratory System:
- dyspnea
- asthma
- epistaxis
- laryngitis
- hiccup
- hyperventilation.
Respiratory System (rare):
- apnea
- hypoventilation.
Skin and Appendages:
- rash
- pruritus
- sweating
- urticaria
- alopecia
Skin and Appendages (rare):
- dry skin
- herpes zoster
- psoriasis
- skin discoloration
Special Senses:
- cataract
- amblyopia
- glaucoma
- dry eyes
- abnormal vision
- tinnitus
- otitis media
Special Senses (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.
As with any drug, you may experience additional Aciphex side effects.
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