Ranitidine (Ranitidine Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 q.i.d. intravenously for 7 days, and in 4 of 24 subjects receiving 50 mg q.i.d. intravenously 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 hyper-secretory patients have resolved when ranitidine has been substituted. However, occasional cases of gynecomastia, 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.

Integumentary:

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

Other:

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

REPORTS OF SUSPECTED RANITIDINE SIDE EFFECTS / ADVERSE REACTIONS

Possible Ranitidine side effects / adverse reactions in 42 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-10-06

Patient: 42 year old female weighing 86.0 kg (189.2 pounds)

Reactions: Intracranial Venous Sinus Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Aranesp
    Indication: Breast Cancer
    Start date: 2007-06-14
    End date: 2007-08-24

Granisetron
    Dosage: on day 0 to 3
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2007-06-13
    End date: 2007-09-30

Taxol
    Dosage: 40 mg/m2 (09-aug-2007 to 27-sep-2007), weekly.
    Indication: Breast Cancer
    Start date: 2007-08-09
    End date: 2007-10-10

Cyclophosphamide
    Indication: Breast Cancer
    Start date: 2007-06-14
    End date: 2007-07-26

Dexamethasone
    Dosage: daily on day 1 to 4, 4mg (13-jun-2007 to 30-sep-2007).
    Indication: Prophylaxis

Ranitidine
    Dosage: 1 df= 50 units nos, once a day on day 1
    Indication: Antiallergic Therapy

Epirubicin
    Indication: Breast Cancer
    Start date: 2007-06-14
    End date: 2007-07-26

Capecitabine
    Dosage: 500 mg/m2 (09-aug-2007 to 27-sep-2007), twice daily.
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2007-08-09
    End date: 2007-10-10

Other drugs received by patient: Ibuprofen

Possible Ranitidine side effects / adverse reactions in 28 year old male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-10-06

Patient: 28 year old male

Reactions: Hypotension, Nodal Rhythm, Dizziness, Bradycardia

Adverse event resulted in: hospitalization

Suspect drug(s):
Sodium Chloride 0.9%
    Dosage: 100 ml;1x; iv
    Indication: Rash

Sodium Chloride 0.9%
    Dosage: 100 ml;1x; iv
    Indication: Pruritus

Sodium Chloride 0.9%
    Dosage: 100 ml;1x; iv
    Indication: Erythema

Ranitidine
    Dosage: 50 mg;1x;iv
    Indication: Pruritus

Ranitidine
    Dosage: 50 mg;1x;iv
    Indication: Rash

Ranitidine
    Dosage: 50 mg;1x;iv
    Indication: Erythema

Pheniramine (Pheniramine)
    Dosage: 45 mg;1x;iv
    Indication: Pruritus

Pheniramine (Pheniramine)
    Dosage: 45 mg;1x;iv
    Indication: Erythema

Pheniramine (Pheniramine)
    Dosage: 45 mg;1x;iv
    Indication: Rash

Possible Ranitidine side effects / adverse reactions in 13 year old male

Reported by a physician from United States on 2011-10-10

Patient: 13 year old male weighing 39.6 kg (87.1 pounds)

Reactions: Anxiety, Confusional State, Akathisia, Pruritus, Pain, Chills, Anger, Memory Impairment, Paraesthesia

Suspect drug(s):
Methotrexate
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Pegaspargase
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Zofran
    Indication: Product Used FOR Unknown Indication

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Bactrim
    Indication: Product Used FOR Unknown Indication

Ranitidine
    Indication: Product Used FOR Unknown Indication

Prednisone
    Dosage: 20mgm2 cyclic
    Administration route: Oral
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Benadryl
    Indication: Product Used FOR Unknown Indication

Cytarabine
    Indication: Precursor B-Lymphoblastic Lymphoma

Hydrocortisone
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Ativan
    Indication: Product Used FOR Unknown Indication

Velcade
    Dosage: 1.3mgm2 cyclic
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Doxorubicin HCL
    Dosage: 60mgm2 cyclic
    Indication: Precursor B-Lymphoblastic Lymphoma
    Start date: 2011-09-08

Scopolamine
    Indication: Product Used FOR Unknown Indication