Download ranitidine oral

Adverse Effects
http://promini.medscape.com/drugdb/drug_u…D452&DrugName=RANITIDINE+ORAL&DrugType=1
RANITIDINE ORAL
Adverse Effects List & Discussion
Adverse Effects List
from First Data Bank
Incidence more frequent
Incidence less frequent
(Uses not currently included in the labeling approved by the
US Food and Drug Administration.)
CONSTIPATION
DIARRHEA
DIZZINESS
DROWSINESS
HEADACHE
NAUSEA
SKIN RASH
VOMITING
AGRANULOCYTOSIS
BRADYCARDIA
BRONCHOSPASM
CONFUSION, DRUG INDUCED
FEVER
TACHYCARDIA
THROMBOCYTOPENIA
None listed
Adverse Effects List
from AHFS DITM
Nervous System Effects from AHFS DITM
Headache (sometimes severe) occurs in approximately 3% of patients receiving ranitidine. Malaise, dizziness, somnolence, insomnia,
and vertigo have been reported less frequently with ranitidine therapy. Reversible mental confusion, agitation, mental depression,
hallucinations have occurred, mainly in debilitated geriatric patients. A child who was receiving prolonged, high-dose oral ranitidine
therapy (8 mg/kg once daily for 10 months) developed altered consciousness, drowsiness, dysarthria, hyporeflexia, positive Babinski's
sign, diaphoresis, and bradycardia, which resolved within 24 hours after discontinuance of the drug. Headache has been reported in 5%
of patients receiving combined therapy with ranitidine bismuth citrate and clarithromycin and in 1% of those receiving ranitidine
bismuth citrate alone in clinical trials. Sleep disorder occurred in 2% of patients receiving combined ranitidine bismuth citrate and
clarithromycin and in less than 1% of those receiving ranitidine bismuthcitrate alone. Tremors have been reported rarely with
ranitidine bismuth citrate therapy; the relationship to the drug is unclear.
GI Effects from AHFS DITM
Constipation, nausea, vomiting, and abdominal discomfort or pain have occurred in patients receiving ranitidine. Pancreatitis has been
reported rarely. Diarrhea, nausea and vomiting, or constipation was reported in 8, 1% of those receiving ranitidine bismuth citrate alone
in clinical trials.
Hepatic Effects from AHFS DITM
Increases in serum aminotransferase (transaminase) (AST [SGOT] and ALT [SGPT]), alkaline phosphatase, LDH, total bilirubin, and
Gamma-glutamyl transferase (Gamma-glutamyltranspeptidase, GOT, GGTP) concentrations have been reported and reversible
hepatitis, which may behepatocellular, hepatocanalicular, or both and may or may not be accompanied by jaundice has occurred
occasionally in individuals receiving ranitidine and usually was reversible; however, death has been reported rarely. In several
multiple-dose studies in healthy individuals, increases in serum AST and ALT concentrations from pretreatment concentrations were
greater in individuals receiving IV ranitidine dosages of 100 mg 4 times daily for 7 days than in those receiving 50 mg 4 times daily for
5 days; the manufacturers state that this apparent dose-related effect of IV ranitidine may indicate that ranitidine has some potential
hepatotoxicity. (See Cautions: Precautions and Contraindications.) Transient changes in AST (SGOT) and ALT (SGPT) werereported in
less than 1% of patients receiving ranitidine bismuth citrate in clinical trials.
Ocular Effects from AHFS DITM
Adverse Effects
http://promini.medscape.com/drugdb/drug_u…D452&DrugName=RANITIDINE+ORAL&DrugType=1
Reversible blurred vision suggestive of a change in accommodation has occurred rarely in patients receiving ranitidine. Exacerbation
of ocular pain and blurred vision associated with increased intraocular pressure and chronic glaucoma have been reported in at least one
patient during ranitidine therapy. Loss of color vision, which recurred following rechallenge, also has occurred in at least one patient.
Endocrine Effects from AHFS DITM
The manufacturers state that ranitidine has not been associated with clinically important effects on endocrine or gonadal function, (See
Pharmacology: Endocrine and Gonadal Effects.) Sexual impotence has occurred in at least one male during ranitidine therapy, but
disappeared following discontinuance of the drug; impotence recurred upon rechallenge. Painful gynecomastia also has occurred during
oral administration of ranitidine, but disappeared gradually following discontinuance of the drug; gynecomastia reappeared upon
rechallenge.
Cardiovascular Effects from AHFS DITM
As with other histamine H2-receptor antagonists, cardiac arrhythmias have occurred rarely in patients receiving ranitidine. Bradycardia,
sometimes associated with dyspnea, has occurred. Because bradycardia has been associated with rapid IV injection of the drug in
some cases, usually in patients with underlying conditions predisposing to cardiac rhythm disturbances, recommended rates of IV
administration should not be exceeded. Tachycardia, AV block, asystole, and ventricular premature complexes have also been reported
rarely.
Other Adverse Effects List
from AHFS DITM
Arthralgias and myalgias have been reported rarely with ranitidine therapy. Rare reports suggest that ranitidine may precipitate acute
attacks of porphyria in patients with acute porphyria; therefore, the drug should be avoided in patients with a history of acute porphyria.
Chest symptoms were reported in 2% of patients receiving combined therapy with ranitidine bismuth citrate and clarithromycin in
clinical trials.
Mutagenicity and Carcinogenicity from AHFS DITM
It is not known if ranitidine is mutagenic or carcinogenic in humans. In vitro tests have generally not shown ranitidine or its Af-oxide, Soxide, and desmethyl metabolites to be mutagenic. No evidence of carcinogenicity was seen in long-term studiesin dogs, mice, or rats
receiving ranitidine dosages up to 2 g/kg daily; evidence of gastric neoplasm or premalignant gastric changes was not observed in these
studies. Like cimetidine, ranitidine increases nitrate-reducing bacterial flora in the GI tract; however, the clinical importance of this
effect is not known.
In a 24-month oral carcinogenicity study in mice, ranitidine bismuth citrate at daily doses up to 1000 mg/kg demonstrated no evidence
of carcinogenicity. For a 50-kg individual of average height (1.46 m2 body surface area), this dose represents 5 times the recommended
clinical dose of 400 mg twice daily (592 mg/m2). In a 24-month oral carcinogenicity study in Sprague-Dawley rats, ranitidine bismuth
citrate at daily doses up to 500 mg/kg, 5 times the recommended human dose based on body surface area, was not carcinogenic.
Ranitidine bismuth citrate was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK±) forward mutation test, the ex
vivo rat gastric mucosal unscheduled DNA synthesis (UDS) test, or the in vivo rat micronucleus test. However, evidence of
genotoxicity was found in the in vitro human lymphocyte chromosomal aberration assay.
Adverse Effects
http://promini.medscape.com/drugdb/drug_u…D452&DrugName=RANITIDINE+ORAL&DrugType=1