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Reglan Side Effects

Generic Name: metoclopramide

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

It is possible that some side effects of Reglan 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 metoclopramide: oral solution, oral syrup, oral tablet, oral tablet disintegrating

Other dosage forms:

As well as its needed effects, metoclopramide (the active ingredient contained in Reglan) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking metoclopramide, check with your doctor immediately:

Rare
  • Abdominal or stomach pain or tenderness
  • chills
  • clay colored stools
  • convulsions (seizures)
  • dark urine
  • difficulty with breathing
  • difficulty with speaking or swallowing
  • dizziness or fainting
  • fast or irregular heartbeat
  • fever
  • general feeling of tiredness or weakness
  • headache (severe or continuing)
  • inability to move the eyes
  • increase in blood pressure
  • increased sweating
  • itching
  • lip smacking or puckering
  • loss of appetite
  • loss of balance control
  • loss of bladder control
  • mask-like face
  • muscle spasms of the face, neck, and back
  • nausea and vomiting
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • shuffling walk
  • skin rash
  • sore throat
  • stiffness of the arms or legs
  • swelling of the feet or lower legs
  • tic-like or twitching movements
  • trembling and shaking of the hands and fingers
  • twisting movements of the body
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusually pale skin
  • weakness of the arms and legs
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking metoclopramide, get emergency help immediately:

Symptoms of overdose
  • Confusion
  • drowsiness (severe)

Some metoclopramide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Diarrhea
  • drowsiness
  • restlessness
Less common or rare
  • Breast tenderness and swelling
  • changes in menstruation
  • constipation
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • increased flow of breast milk
  • increased need to urinate
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • passing urine more often
  • skin rash
  • trouble sleeping
  • unusual dryness of the mouth
  • unusual irritability

For Healthcare Professionals

Applies to metoclopramide: compounding powder, injectable solution, oral concentrate, oral syrup, oral tablet, oral tablet disintegrating

Nervous system

Tardive dyskinesia involves involuntary, dyskinetic, repetitive movements and may be more common in elderly women. Tardive dyskinesia may be irreversible and is related to both the duration of therapy and the total amount of drug consumed. Frequent discontinuation and resumption of therapy may predispose patients to the development of tardive dyskinesia.

Dystonias frequently involve tongue protrusions, muscle rigidity, torticollis, and opisthotonos. Dystonias usually resolve after metoclopramide (the active ingredient contained in Reglan) discontinuation, but may require antihistamine and antiparkinsonian therapy if symptoms are severe or if respiration is compromised. Treatment of dystonic reactions and extrapyramidal effects, in addition to general supportive measures, may include judicious use of one or more of the following: benztropine or diphenhydramine.

Hyperthermia, altered consciousness, autonomic dysfunction, and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of metoclopramide therapy, consideration of dantrolene administration, as well as intensive monitoring and supportive care are indicated.

Drug-induced parkinsonian symptoms due to metoclopramide may be misdiagnosed and inappropriately treated with dopaminergic agents. Parkinsonian-like symptoms have occurred, more commonly within the first 6 months from the start of therapy with metoclopramide, but occasionally after longer periods. Caution should be exercised when diagnosing movement disorders in patients currently being treated with metoclopramide. Additionally, metoclopramide should be avoided in patients with confirmed Parkinson's disease.

Patients with AIDS or HIV-positive may be at an increased risk of developing acute dystonia to metoclopramide use. Decreases in dopamine levels have been observed in a study of AIDS patients without clinical neurologic disease. Similarly, HIV-positive patients have shown a decreased response in serum prolactin during intravenous infusion of metoclopramide when compared with controls, interpreted as an indirect evidence of a diminished endogenous dopamine tone.[Ref]

Nervous system side effects have been commonly reported and included drowsiness, fatigue, restlessness, and lassitude in approximately 10% of patients. Drowsiness may occur in up to 70% of cancer patients treated with high-dose (1 to 2 mg/kg/dose) metoclopramide. Tardive dyskinesia, dystonia, pseudo-parkinsonism, and the neuroleptic malignant syndrome have also been reported. In addition, cases of akathisia have been reported. Seizures and hallucinations have been reported rarely. At least one case of lightheadedness has also been reported.[Ref]

Endocrine

Endocrine side effects have included galactorrhea, amenorrhea, gynecomastia, and impotence secondary to hyperprolactinemia. In addition, metoclopramide (the active ingredient contained in Reglan) may cause a transient increase in circulating aldosterone levels and subsequently cause edema.[Ref]

Psychiatric

Psychiatric side effects have included depression, anxiety, mania, psychosis, and insomnia.[Ref]

Depression may occur in patients without prior history of depression or other psychiatric illness and may be severe. Suicidal ideation may be present. Several reports suggest that dose reduction may alleviate depressive symptomatology. In addition, reintroduction of metoclopramide with slow titration of the dose upwards to a therapeutic level has been successful in some patients.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension, hypotension, supraventricular tachycardia, bradycardia, and cardiac arrest. In addition, metoclopramide (the active ingredient contained in Reglan) is associated with hypertensive crisis in patients with pheochromocytoma and has been implicated in a case of congestive heart failure.[Ref]

It is postulated that metoclopramide may indirectly cause release of catecholamines from tumors in pheochromocytoma patients. Hypertensive crisis may ensue. The use of metoclopramide is considered contraindicated in patients with pheochromocytoma.

Hypertensive crisis has been documented in the absence of pheochromocytoma as well. The manufacturer recommends cautious use of metoclopramide in patients with essential hypertension.

Sinus bradycardia (50 beats per minute) progressing to complete heart block with sinus arrest has been reported in a 54-year-old man after receiving metoclopramide 10 mg IV. Asystole lasted approximately 25 seconds, followed by a spontaneous increase in heart rate to 80 beats per minute in sinus rhythm with a blood pressure of 140/70 mm Hg. Similar effects were observed on rechallenge with a dose of metoclopramide 5 mg given slowly. No changes in ST segment or QRS complexes were observed on electrocardiogram.[Ref]

Hematologic

Patients with NADH-cytochrome b5 reductase deficiency who need to receive metoclopramide (the active ingredient contained in Reglan) are at increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. The treatment of metoclopramide-induced methemoglobinemia with methylene blue is not recommended in patients with G6PD deficiency.[Ref]

Hematologic side effects including leukopenia, neutropenia, porphyria, and agranulocytosis have been reported rarely. Methemoglobinemia has also been reported with metoclopramide use in adults, but may be more common in infants who are treated with high doses.[Ref]

Hepatic

Hepatic side effects have included rare reports of elevations in liver function tests and jaundice. A case of arteriovenous shunting and cholestasis in conjunction with hepatic hemangiomatosis has been reported.[Ref]

A 22-year-old female, treated with metoclopramide 10 to 15 mg per day for 7 to 8 months for abdominal pain, developed hepatic hemangiomatosis with arteriovenous shunting and cholestasis. Hyperprolactinemia, galactorrhea, amenorrhea, and virilization were also noted on initial presentation. The patient was placed on a waiting list for liver transplantation. However, complete, albeit slow, resolution occurred following discontinuation of metoclopramide.[Ref]

Genitourinary

Genitourinary side effects have included urinary frequency, incontinence, and urinary retention.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rash, urticaria, bronchospasm, angioneurotic edema, and glossal or laryngoedemal reactions.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.[Ref]

Respiratory

Respiratory side effects have been reported rarely. A case of metoclopramide-induced bronchospasm is reported in the literature.[Ref]

Other

Other side effects have included porphyria, local pain during intravenous injection, and transient flushing during high-dose infusion. At least one case of generalized weakness has been reported.[Ref]

Renal

Renal side effects have included urinary frequency and incontinence.[Ref]

Ocular

Ocular side effects have included visual disturbances. Decrease in pupil diameter and transiently depressed reflex dilation have been reported in patients undergoing lower abdominal surgery under combined epidural/general anesthesia.[Ref]

Musculoskeletal

Musculoskeletal side effects have included a case of dystonic reaction.[Ref]

A 28-year-old female experienced dystonic reaction coincident with metoclopramide therapy. She had started taking metoclopramide the day before her presentation to the hospital. Her symptoms resolved six to eight hours after onset.[Ref]

General

In general, the incidence of side effects correlates with dose and duration of metoclopramide (the active ingredient contained in Reglan) therapy. The elderly may be more susceptible to developing adverse effects due to the changes in organ function, concomitant diseases, and other drug therapies.[Ref]

References

1. Friedman LS, Weinrauch LA, D'Elia JA "Metoclopramide-induced neuroleptic malignant syndrome." Arch Intern Med 147 (1987): 1495-7

2. The Oral Sumatriptan and Aspirin plus Metoclopramide Comparative Study Group "A study to compare oral sumatriptan with oral aspirin plus oral metoclopramide in the acute treatment of migraine." Eur Neurol 32 (1996): 177-84

3. van Der Kleij FG, de Vries PA, Stassen PM, Sprenger HG, Gans RO "Acute dystonia due to metoclopramide: increased risk in AIDS." Arch Intern Med 162 (2002): 358-9

4. Grimes JD "Parkinsonism and tardive dyskinesia associated with long-term metoclopramide therapy." N Engl J Med 305 (1981): 1417

5. Desmond PV, Watson KJ "Metoclopramide--a review." Med J Aust 144 (1986): 366-9

6. Palop V, Jimenez MJ, Catalan C, MartinezMir I "Acute dystonia associated with fluvoxamine-metoclopramide." Ann Pharmacother 33 (1999): 382

7. Bakri YN, Khan R, Subhi J, Kawi Z "Neuroleptic malignant syndrome associated with metoclopramide antiemetic therapy." Gynecol Oncol 44 (1992): 189-90

8. Henzi I, Walder B, Tramer MR "Metoclopramide in the prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized, placebo-controlled studies." Br J Anaesth 83 (1999): 761-71

9. Henderson A, Longdon P "Fulminant metoclopramide induced neuroleptic malignant syndrome rapidly responsive to intravenous dantrolene." Aust N Z J Med 21 (1991): 742-3

10. Ganzini L, Casey DE, Hoffman WF, McCall AL "The prevalence of metoclopramide-induced tardive dyskinesia and acute extrapyramidal movement disorders." Arch Intern Med 153 (1993): 1469-75

11. Sirota RA, Kimmel PL, Trichtinger MD, Diamond BF, Stein HD, Yudis M "Metoclopramide-induced parkinsonism in hemodialysis patients. Report of two cases." Arch Intern Med 146 (1986): 2070-1

12. "Product Information. Reglan (metoclopramide)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

13. Nonino F "Neuroleptic malignant syndrome associated with metoclopramide." Ann Pharmacother 33 (1999): 644-5

14. Akagi H, Kumar TM "Lesson of the week: Akathisia: overlooked at a cost." BMJ 324 (2002): 1506-7

15. Donnet A, Harle JR, Dumont JC, Alif Cherif A "Neuroleptic malignant syndrome induced by metoclopramide." Biomed Pharmacother 45 (1991): 461-2

16. Avorn J, Gurwitz JH, Bohn RL, Mogun H, Monane M, Walker A "Increased incidence oflevodopa therapy following metoclopramide use." JAMA 274 (1995): 1780-2

17. Robinson D, Omar SJ, Dangel C, Fenn H, Tinklenberg J "Metoclopramide-induced extra pyramidal symptoms in a diabetic patient." J Am Geriatr Soc 42 (1994): 1307-8

18. LaGorio J, Thompson VA, Sternberg D, Dorje P "Akathisia and anesthesia: Refusal of surgery after the administration of metoclopramide." Anesth Analg 87 (1998): 224-7

19. Miller LG, Jankovic J "Metoclopramide-induced movement disorders. Clinical findings with a review of the literature." Arch Intern Med 149 (1989): 2486-92

20. Sewell DD, Kodsi AB, Caligiuri MP, Jeste DV "Metoclopramide and tardive dyskinesia." Biol Psychiatry 36 (1994): 630-2

21. Lou E, Abou-Zeid N "A case of metoclopramide-induced oculogyric crisis in a 16-year-old girl with cystic fibrosis." South Med J 99 (2006): 1290-1

22. Pall HS, Williams AC "Extrapyramidal disturbances caused by inappropriate prescribing." Br Med J (Clin Res Ed) 295 (1987): 30-1

23. Friedman BW, Esses D, Solorzano C, et al. "A Randomized Controlled Trial of Prochlorperazine Versus Metoclopramide for Treatment of Acute Migraine." Ann Emerg Med (2007):

24. Berlin RG "Metoclopramide-induced reversible impotence." West J Med 144 (1986): 359-61

25. Blumberg AL, Dubb JW, Allison NL, et al "Selectivity of metoclopramide for endocrine versus renal effects of dopamine in normal humans." J Cardiovasc Pharmacol 11 (1988): 181-6

26. Feurle GE "Arteriovenous shunting and cholestasis in hepatic hemangiomatosis associated with metoclopramide." Gastroenterology 99 (1990): 258-62

27. Anderson OP, Hansen P, Madsen H "Hyperprolactinemic amenorrhea induced by metoclopamid (Primperan R)." Acta Obstet Gynecol Scand 60 (1981): 341-2

28. Aono T, Shioji T, Kinugasa T, Onishi T, Kurachi K "Clinical and endocrinological analyses of patients with galactorrhea and menstrual disorders due to sulpiride or metoclopramide." J Clin Endocrinol Metab 47 (1978): 675-80

29. Bottner RK, Tullio CJ "Metoclopramide and depression." Ann Intern Med 103 (1985): 482

30. Weddington WW, Jr Banner A "Organic affective syndrome associated with metoclopramide: case report." J Clin Psychiatry 47 (1986): 208-9

31. Lu ML, Pan JJ, Teng HW, Su KP, Shen WW "Metoclopramide-induced supersensitivity psychosis." Ann Pharmacother 36 (2002): 1387-90

32. Adams CD "Metoclopramide and depression." Ann Intern Med 103 (1985): 960

33. Ritchie KS, Preskorn SH "Mania induced by metoclopramide: case report." J Clin Psychiatry 45 (1984): 180-1

34. Kohli-Kumar M, Pearson AD, Sharkey I, Craft AW "Urinary retention--an unusual dystonic reaction to continuous metoclopramide infusion." DICP 25 (1991): 469-70

35. Feder R "Metoclopramide and depression." J Clin Psychiatry 48 (1987): 38

36. Abe M, Orita Y, Nakashima Y, Nakamura M "Hypertensive crisis induced by metoclopramide in patient with pheochromocytoma." Angiology 35 (1984): 122-8

37. Hughes RL "Hypotension and dysrhythmia following intravenous metoclopramide." Anaesthesia 39 (1984): 720

38. Agabiti-Rosei E, Aliccandri CL, Corea L "Hyperstensive crisis in patients with phaeochromocytoma given metoclopramide." Lancet 1 (1977): 600

39. Bentsen G, Stubhaug A "Cardiac arrest after intravenous metoclopramide - a case of five repeated injections of metoclopramide causing five episodes of cardiac arrest." Acta Anaesthesiol Scand 46 (2002): 908-10

40. Park GR "Hypotension following the intravenous injection of metoclopramide." Anaesthesia 36 (1981): 75-6

41. Bevacqua BK "Supraventricular tachycardia associated with postpartum metoclopramide administration." Anesthesiology 68 (1988): 124-5

42. Filibeck DJ, Grimm D, Forman WB, Leidner BA "Metoclopramide-induced hypertensive crisis." Clin Pharm 3 (1984): 548-9

43. Ahmad S "Metoclopramide-induced acute congestive heart failure." South Med J 84 (1991): 283-4

44. Plouin PF, Menard J, Corval P "Hypertensive crisis in patient with phaeochromocytoma given metoclopramide." Lancet 2 (1976): 1357-8

45. Malkoff MD, Ponzillo JJ, Myles GL, Gomez CR, Cruz-Flores S "Sinus arrest after administation of intravenous metoclopramide." Ann Pharmacother 29 (1995): 381-3

46. Midttun M, Oberg B "Total heart block after intravenous metoclopramide." Lancet 343 (1994): 182-3

47. Withington DE "Dysrythmias following intravenous metoclopramide." Intensive Care Med 12 (1986): 378-9

48. Manoharan A "Metoclopramide-induced agranulocytosis." Med J Aust 149 (1988): 508

49. Harvey RL, Luzar MJ "Metoclopramide-induced agranulocytosis." Ann Intern Med 108 (1988): 214-5

50. Grant SCD, Close JR, Bray CL "Methaemoglobinaemia produced by metoclopramide in an adult." Eur J Clin Pharmacol 47 (1994): 89

51. MacLaren R, Shields CA "Respiratory failure following oral administration of metoclopramide." Ann Pharmacother 32 (1998): 1017-20

52. Chung MM, Chetty KG, Jerome D "Metoclopramide and asthma." Ann Intern Med 103 (1985): 809

53. Larson MD "The effect of antiemetics on pupillary reflex dilation during epidural/general anesthesia." Anesth Analg 97 (2003): 1652-6

54. Dingli K, Morgan R, Leen C "Tetanus versus acute dystonic reaction caused by metoclopramide, versus tetanus." BMJ 334 (2007): 899-900

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