Zantac 25 mg EFFERdose Side Effects

Generic Name: ranitidine

Note: This page contains side effects data for the generic drug ranitidine. It is possible that some of the dosage forms included below may not apply to the brand name Zantac 25 mg EFFERdose.

It is possible that some side effects of Zantac 25 mg EFFERdose may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ranitidine: oral solution, oral tablets and tablets for, oral tablets effervescent for solution, parenteral injection, parenteral injection for iv infusion only

Side effects include:

Oral or parenteral therapy: Headache, sometimes severe.

IM therapy: Transient pain at injection site.

IV therapy: Transient local burning or itching.

For Healthcare Professionals

Applies to ranitidine: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule effervescent, oral syrup, oral tablet, oral tablet effervescent

General

Ranitidine (the active ingredient contained in Zantac 25 mg EFFERdose) is generally well tolerated.[Ref]

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 (the active ingredient contained in Zantac 25 mg EFFERdose) predisposing the patient to the enteric infection.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Hematologic

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 (the active ingredient contained in Zantac 25 mg EFFERdose) 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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Nervous system

The mechanism by which ranitidine (the active ingredient contained in Zantac 25 mg EFFERdose) 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.[Ref]

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.[Ref]

Renal

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

Dermatologic

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

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.[Ref]

Ocular

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

Other

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

Cardiovascular

Cardiovascular side effects have rarely included tachycardia, bradycardia, atrioventricular block, and premature ventricular beats. Several cases of bradycardia following intravenous administration of ranitidine (the active ingredient contained in Zantac 25 mg EFFERdose) 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.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgias and myalgias.[Ref]

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.

References

1. Wormsley KG "Safety profile of ranitidine - a review." Drugs 46 (1993): 976-85

2. "Product Information. Zantac (ranitidine)." Glaxo Wellcome, Research Triangle Park, NC.

3. Elomar E, Banerjee S, Wirz A, Penman I, Ardill JES, Mccoll KEL "Marked rebound acid hypersecretion after treatment with ranitidine." Am J Gastroenterol 91 (1996): 355-9

4. Herrmann R, Shaw RG, Fone DJ "Ranitidine-associated recurrent acute pancreatitis." Aust N Z J Med 20 (1990): 243-4

5. Khatami SS, Mukunda B, Ravakhah K "Coinfection with Giardia lamblia and Clostridium difficile after Use of Ranitidine." Am J Med Sci 327 (2004): 91-3

6. Koch-Weser J, Zeldis JB, Friedman LS, Isselbacher KJ "Ranitidine: a new H2-receptor antagonist." N Engl J Med 309 (1983): 1368-73

7. Beaugerie L, Patey N, Brousse N "Ranitidine, diarrhoea, and lymphocytic colitis." Gut 37 (1995): 708-11

8. Brogden RN, Carmine AA, Heel RC, et al "Ranitidine: a review of its pharmacology and therapeutic use in peptic ulcer disease and other allied diseases." Drugs 24 (1982): 267-303

9. Souza-Lima MA "Hepatitis associated with ranitidine." Ann Intern Med 101 (1984): 207-8

10. Ramrakhiani S, Brunt EM, Bacon BR "Possible cholestatic injury from ranitidine with a review of the literature." Am J Gastroenterol 93 (1998): 822-6

11. Ribeiro JM, Lucas M, Baptista A, Victorino RMM "Fatal hepatitis associated with ranitidine." Am J Gastroenterol 95 (2000): 559-60

12. Black M, Scott WE Jr, Kanter R "Possible ranitidine hepatotoxicity." Ann Intern Med 101 (1984): 208-10

13. Hiesse C, Cantarovich M, Santelli C, et al "Ranitidine hepatotoxicity in renal transplant patient." Lancet 06/01/85 (1985): 1280

14. Khandheria BK "Hypersensitivity associated with ranitidine ." JAMA 252 (1984): 3252

15. Greer IA, Fellows K "Anaphalactoid reaction to ranitidine in labour." Br J Clin Pract 44 (1990): 78

16. Picardo M, Santucci B "Urticaria from ranitidine." Contact Dermatitis 9 (1983): 327

17. Kavanagh GM, Warwick JA, Burton JL "Ranitidine fever." Lancet 341 (1993): 1422

18. Haboubi N, Asquith P "Rash mediated by immune complexes associated with ranitidine treatment." Br Med J 296 (1988): 897

19. Andreu V, Bataller R, Caballeria J, Rodes J "Acute eosinophilic pneumonia associated with ranitidine." J Clin Gastroenterol 23 (1996): 160-2

20. Gafter U, Komlos L, Weinstein T, et al "Thrombocytopenia, eosinophilia, and ranitidine ." Ann Intern Med 106 (1987): 477

21. Gibson PR, Pidcock ME "Immune-mediated thrombocytopenia associated with ranitidine therapy ." Med J Aust 145 (1986): 661-2

22. Brenner LO "Agranulocytosis and ranitidine ." Ann Intern Med 104 (1986): 896-7

23. Spychal RT, Wickham NW "Thrombocytopenia associated with ranitidine." Br Med J 291 (1985): 1687

24. Lane GP, Speed B "Agranulocytosis after ranitidine administration." Med J Aust 150 (1989): 595-6

25. Pixley JS, MacKintosh FR, Sahr EA, Zanjani ED "Mechanism of ranitidine associated anemia." Am J Med Sci 297 (1988): 369-71

26. Corinaldesi R, Pasquali R, Paternico A, et al "Effects of short- and long-term administrations of famotidine and ranitidine on some pituitary, sexual and thyroid hormones." Drugs Exp Clin Res 13 (1987): 647-54

27. Berner BD, Conner CS, Sawyer DR, Siepler JK "Ranitidine: a new H2-receptor antagonist." Clin Pharm 1 (1982): 499-509

28. Knigge U, Thuesen B, Dejgaard A, et al "Plasma concentrations of pituitary and peripheral hormones during ranitidine treatment for two years in men with duodenal ulcer." Eur J Clin Pharmacol 37 (1989): 305-7

29. Chisholm JC, Jr "Ranitidine hydrochloride-induced hypergastrinemia." J Natl Med Assoc 77 (1985): 303-4

30. Fiore CE, Lunetta M, Kanis JA "Long-term effects of histamine H2-receptor antagonists on serum parathyroid hormone in chronic renal failure." Clin Endocrinol (Oxf) 23 (1985): 277-82

31. Billings RF, Stein MB "Depression associated with ranitidine." Am J Psychiatry 143 (1986): 915-6

32. Marinella MA "Ranitidine associated visual hallucinations." J Clin Gastroenterol 23 (1996): 238

33. Patterson JF "Mania associated with intravenous ranitidine therapy ." South Med J 80 (1987): 1467

34. Durand JM, Suchet L, Morange S, Michel B "Ranitidine and aseptic meningitis (vol 312, pg 886, 1996)." BMJ 312 (1996): 1392

35. Sonnenblick M, Yinnon A "Mental confusion as a side effect of ranitidine ." Am J Psychiatry 143 (1986): 257

36. Cantu TG, Korek JS "Central nervous system reactions to histamine-2 receptor blockers." Ann Intern Med 114 (1991): 1027-34

37. Davis BJ, Aul EA, Granner MA, Rodnitzky RL "Ranitidine-induced cranial dystonia." Clin Neuropharmacol 17 (1994): 489-91

38. Delerue O, Muller JP, Destee A, Warot P "Mania-like episodes associated with ranitidine ." Am J Psychiatry 145 (1988): 271

39. Slugg PH, Haug MT, Pippenger CE "Ranitidine pharmacokinetics and adverse central nervous system reactions." Arch Intern Med 152 (1992): 2325-9

40. Picotte-Pillmayer D, DiMaggio JR, Baile WF "H-2 blocker delirium." Psychosomatics 36 (1995): 74-7

41. Gaughan WJ, Sheth VR, Francos GC, Michael HJ, Burke JF "Ranitidine-induced acute interstitial nephritis with epithelial cell foot process fusion." Am J Kidney Dis 22 (1993): 337-40

42. Neelakantappa K, Gallo GR, Lowenstein J "Ranitidine-associated interstitial nephritis and Fanconi syndrome." Am J Kidney Dis 22 (1993): 333-6

43. Miralles ES, Nunez M, Delolmo N, Ledo A "Ranitidine-related toxic epidermal necrolysis in a patient with idiopathic thrombocytopenic purpura." J Am Acad Dermatol 32 (1995): 133-4

44. Velez A, Moreno JC "Second case of ranitidine-related toxic epidermal necrolysis in a patient with idiopathic thrombocytopenic purpura." J Am Acad Dermatol 42 (2000): 305

45. Todd P, Norris P, Hawk JLM, Duvivier AWP "Ranitidine-induced photosensitivity." Clin Exp Dermatol 20 (1995): 146-8

46. Goh CL, Ng SK "Allergic contact dermatitis to ranitidine." Contact Dermatitis 11 (1984): 252

47. Alomar A, Puig L, Vilaltella I "Allergic contact dermatitis due to ranitidine." Contact Dermatitis 17 (1987): 54-5

48. Khera DC, Smith SL, Slabic SF "Ranitidine-induced bradycardia ." Am J Gastroenterol 83 (1988): 332-3

49. Allegri G, Pellegrini K, Dobrilla G "First-degree atrioventricular block in a young duodenal ulcer patient treated with a standard oral dose of ranitidine." Agents Actions 24 (1988): 237-42

50. Nault MA, Milne B, Parlow JL "Effects of the Selective H1 and H2 Histamine Receptor Antagonists Loratadine and Ranitidine on Autonomic Control of the Heart." Anesthesiology 96 (2002): 336-341

51. Alliet P, Devos E "Ranitidine-induced bradycardia in a neonate - secondary to congenital long QT interval syndrome?" Eur J Pediatr 153 (1994): 781

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