Zantac (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 ZANTAC. The relationship to therapy with ZANTAC has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ZANTAC.

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 ZANTAC and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ZANTAC has been substituted. However, occasional cases of gynecomastia, impotence, and loss of libido have been reported in male patients receiving ZANTAC, 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.

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.

REPORTS OF SUSPECTED ZANTAC SIDE EFFECTS / ADVERSE REACTIONS

Possible Zantac side effects / adverse reactions in 75 year old female

Reported by a individual with unspecified qualification from United States on 2011-10-05

Patient: 75 year old female weighing 73.5 kg (161.7 pounds)

Reactions: Malaise, Nausea, Diarrhoea, Dizziness, Headache, Nervousness

Suspect drug(s):
Zantac

Possible Zantac side effects / adverse reactions in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-07

Patient: 45 year old male weighing 80.0 kg (176.0 pounds)

Reactions: Respiratory Disorder, Skin Exfoliation, Effusion, Petechiae, Pyrexia, Erythema, LIP Erosion, Multi-Organ Failure, Skin Lesion, Erythema Multiforme, Blister, Pneumonia, Retinal Haemorrhage, Toxic Epidermal Necrolysis, Rash, Skin Plaque, Nikolsky's Sign, Staphylococcal Infection, Ocular Hyperaemia, Scrotal Ulcer, Skin Erosion, Blood Pressure Decreased

Adverse event resulted in: death

Suspect drug(s):
Meropenem
    Dosage: .5g per day
    Indication: Infection
    Start date: 2009-08-16
    End date: 2009-08-20

Cefazolin
    Dosage: 1g per day
    Start date: 2009-07-31
    End date: 2009-07-31

Piperacillin Sodium
    Dosage: 2g per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-31
    End date: 2009-07-31

Piperacillin Sodium
    Dosage: 4g per day
    Start date: 2009-08-01
    End date: 2009-08-10

Phenytoin Sodium CAP
    Dosage: 125mg per day
    Start date: 2009-08-20
    End date: 2009-08-20

Zantac
    Dosage: 200mg per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-25
    End date: 2009-08-13

Meropenem
    Dosage: .5g per day
    Start date: 2009-08-24
    End date: 2009-08-24

Cefazolin
    Dosage: 2g twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-25
    End date: 2009-07-30

Meropenem
    Dosage: 1g per day
    Start date: 2009-08-21
    End date: 2009-08-23

Phenytoin Sodium CAP
    Dosage: 250mg per day
    Indication: Grand MAL Convulsion
    Start date: 2009-08-15
    End date: 2009-08-19

Firstcin
    Dosage: 1g per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-08-11
    End date: 2009-08-11

Firstcin
    Dosage: .5g per day
    Start date: 2009-08-12
    End date: 2009-08-14

Other drugs received by patient: Bisolvon; Vitaject; Elemenmic; Coniel; Nafamostat Mesilate; Heparin Sodium; Methoxamine Hydrochloride; Nicardipine HCL; Calcium Carbonate; Midazolam HCL; Norepinephrine Bitartrate; Vitamedin; Unknown; Bisolvon; Unknown; Propofol; Potassium Chloride; Midazolam HCL; Heparin Sodium; Millisrol (Japan); Furosemide; Furosemide; Ephedrine Hydrochloride; NEO-Minophagen-C; Elaspol; Midazolam HCL; Hicaliq; Vitaject; Heparin Sodium; Buprenorphine HCL; Midazolam HCL; Heparin Sodium; Urso 250; LAC B; Biofermin; Stadol; Dobutrex; Pantol; Pantol; Hicaliq; Elemenmic; Urso 250; Lendormin; Dopamine HCL; Ketalar; Stadol; Neoamiyu; Neoamiyu; Heparin Sodium; Unknown; Nicardipine HCL

Possible Zantac side effects / adverse reactions in 72 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 72 year old female weighing 58.0 kg (127.7 pounds)

Reactions: Weight Decreased, Tongue DRY, Anxiety, Burn Oesophageal, Tongue Disorder, Hair Texture Abnormal, Gastrointestinal Disorder, DRY Mouth, Drug Dependence, Decreased Appetite

Adverse event resulted in: disablity

Suspect drug(s):
Norvasc
    Dosage: (7.5 mg, 1 d), oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01

Lisinopril
    Indication: Hypertension

Plavix
    Indication: Anticoagulant Therapy

Zantac
    Dosage: (600 mg, 1 d),
    Indication: Burn Oesophageal

Zantac
    Dosage: (600 mg, 1 d),
    Indication: Gastrooesophageal Reflux Disease

Catapres
    Dosage: (1 wk), transdermal
    Indication: Hypertension
    Start date: 2010-01-01

Metoprolol Tartrate
    Dosage: 40 mg (20 mg, 2 in 1 d), oral
    Administration route: Oral
    Start date: 2010-01-01

Xanax
    Dosage: 1 and 1/4 mg tablets ( by splitting 1mg) (1 d), oral 3/4 tablet (1 d), oral
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-06-08

Celexa
    Dosage: (120 mg), (10 mg),
    Indication: Anxiety

Benicar
    Dosage: (40 mg, 1 d),
    Indication: Hypertension
    Start date: 2010-01-01