Ranitidine Side Effects

Brand Names: Zantac, Zantac 75

Please note - some side effects for Ranitidine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Ranitidine - for the Consumer

Ranitidine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ranitidine:

Constipation; diarrhea; headache; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Ranitidine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; confusion; dark urine; depression; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; severe or persistent headache or stomach pain; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ranitidine Effervescent Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ranitidine Effervescent Tablets:

Constipation; diarrhea; headache; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Ranitidine Effervescent Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; confusion; dark urine; depression; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; severe or persistent headache or stomach pain; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ranitidine Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ranitidine Syrup:

Constipation; diarrhea; headache; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Ranitidine Syrup:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; confusion; dark urine; depression; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; severe or persistent headache or stomach pain; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ranitidine Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ranitidine Tablets:

Constipation; diarrhea; headache; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Ranitidine Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; confusion; dark urine; depression; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; severe or persistent headache or stomach pain; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Ranitidine Side Effects - for the Professional

Ranitidine

The following have been reported as events in clinical trials or in the routine management of patients treated with Ranitidine. The relationship to therapy with Ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Ranitidine.

Central Nervous System:

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.

Cardiovascular:

As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Gastrointestinal:

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.

Hepatic:

There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, Ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intavenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.

Musculoskeletal:

Rare reports of arthralgias and myalgias.

Hematologic:

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.

Endocrine:

Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when Ranitidine has been substituted. However, occasional cases of impotence, and loss of libido have been reported in male patients receiving Ranitidine, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.

Integumentary:

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.

Respiratory:

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared to patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07 - 2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established.

Other:

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

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Side Effects by Body System - for Healthcare Professionals

General

Ranitidine is generally well tolerated.

Gastrointestinal

Gastrointestinal side effects have included constipation, nausea/vomiting, diarrhea, abdominal pain, and rare reports of pancreatitis. Rebound acid hypersecretion has been reported after discontinuation of therapy. A case report of coinfection with Giardia lamblia and Clostridium difficile has been attributed to the achlorhydria induced by ranitidine predisposing the patient to the enteric infection.

Hepatic

Hepatic side effects have included transient and minor increases in serum transaminases, which may be important in patients with liver disease. There are rare reports of ranitidine-induced hepatitis with or without jaundice, one case of subfulminant hepatitis with a fatal outcome, and very rare cases of acute interstitial nephritis.

Overall, serious hepatotoxicity due to ranitidine is rare. Hepatocellular, hepatocanalicular, and mixed-type injury have been reported. In most cases, hepatotoxicity has been associated with fever, chills, nausea, and occasionally rash and eosinophilia, with onset of symptoms early in the course of therapy. Such symptomatology is suggestive of a hypersensitivity etiology. The majority of cases resolve following discontinuation of ranitidine therapy although, at least two fatalities have been reported.

In a study with healthy volunteers , SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously four times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously four times daily for 5 days.

Hypersensitivity

Hypersensitivity side effects have included rash, urticaria, bronchospasm, fever, eosinophilia, angioneurotic edema, acute eosinophilic pneumonia and anaphylaxis. Vasculitis associated with immune complexes has also been reported.

Hematologic

Hematologic side effects have included leukopenia, granulocytopenia, and thrombocytopenia in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, aplastic anemia, and acquired immune hemolytic anemia have been reported.

Serious hematologic abnormalities are rare. Patients with renal dysfunction or those who are critically ill may be at increased risk. While the mechanism of bone marrow toxicity is unknown, ranitidine concentration-dependent inhibition of hematopoietic progenitor cell activity and hypersensitivity have both been proposed. Hematologic abnormalities typically resolve upon discontinuation of ranitidine therapy.

Cases of ranitidine-induced thrombocytopenia are typically immune-mediated.

Endocrine

Endocrine side effects have been reported rarely. These have included gynecomastia, impotence, and loss of libido in male patients, although, the incidence was similar to that in the general population. Hyperprolactinemia, amenorrhea, reductions in circulating levothyroxine and hypergastrinemia have also been reported.

Ranitidine does not possess antiandrogenic properties nor has it been associated with significant changes in pituitary hormone concentrations under study conditions. However, increases in prolactin serum concentrations following administration of high doses as well as decreases in levothyroxine serum concentrations during short-term therapy have been reported. Thyroid hormone levels are not affected during long-term therapy.

Nervous system

The mechanism by which ranitidine induces mental status changes is not well established but appears to involve increased serum concentrations of ranitidine. Renal dysfunction, advanced age, and critical illness appear to be associated with an increased risk of central nervous system toxicity. Onset of symptoms is typically within the first few weeks of therapy, but may be delayed. Following discontinuation of ranitidine, mental status usually normalizes over several days.

Nervous system side effects have been reported rarely. These have included headache (sometimes severe), somnolence, dizziness, malaise, and vertigo. Reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Hostility, mania, mental status changes, dystonia, reversible involuntary motor disturbances have also been reported.

Renal

Renal side effects have included mild elevations in serum creatinine. Rare cases of interstitial nephritis and Fanconi's syndrome have been reported.

Dermatologic

Dermatologic side effects have included alopecia, rash, pruritus, contact dermatitis, erythema multiforme, cutaneous vasculitis, and toxic epidermal necrolysis.

Two cases of toxic epidermal necrolysis have been reported in patients with underlying idiopathic thrombocytopenia purpura. A 72-year-old male also experienced a photosensitivity reaction that resolved after ranitidine was discontinued.

Ocular

Ocular side effects have included blurred vision and increased intraocular pressure in a patient with a history of glaucoma.

Other

Other reported side effects have included tiredness and one case of aseptic meningitis.

Cardiovascular

Cardiovascular side effects have rarely included tachycardia, bradycardia, atrioventricular block, and premature ventricular beats. Several cases of bradycardia following intravenous administration of ranitidine have been reported. Ranitidine-induced bradycardia may be due to a rise in the serum histamine concentration or due to a direct effect of ranitidine on cardiac H2 receptors.

Musculoskeletal

Musculoskeletal side effects have included arthralgias and myalgias.

Respiratory

Respiratory side effects have included an increased risk of developing pneumonia in patients taking H2 receptor antagonists versus those who had stopped treatment. However, a causal relationship has not been established.

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