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Zantac (Ranitidine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zantac (Ranitidine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (424)
Death (16)
Life Threatening Events (28)
Disability (29)

Reports by Reaction Type

Drug Ineffective (76)Dyspepsia (39)Malaise (35)Dyspnoea (29)Chronic Obstructive Pulmonary Disease (24)Gastrooesophageal Reflux Disease (23)Emphysema (23)Nausea (22)Amnesia (22)Bedridden (21)Chest Pain (19)Erythema (18)

Below are a few examples of reports where side effects / adverse reactions may be related to Zantac (Ranitidine). For a complete list or a specific selection of reports, please use the links above.

Possible Zantac side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Dyspepsia

Drug(s) suspected as cause:
Zantac

Zantac
    Dosage: 300 mg
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2012-07-30



Possible Zantac side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient:

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Desloratadine
    Dosage: unk
    Administration route: Oral
    Indication: Eyelid Oedema
    Start date: 2012-07-26

Zantac
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-26



Possible Zantac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Zantac



Possible Zantac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Bedridden, Emphysema, Off Label Use, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 81 mg, prn
    Indication: Chest Pain

Atenolol
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension

Ativan
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Nervousness

Atropine Sulfate
    Dosage: 2.5 mg, qid
    Administration route: Oral
    Indication: Crohn's Disease

Depakote
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Convulsion

Dilantin
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Convulsion

Furosemide
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Diuretic Therapy

Generlac
    Dosage: 30 mg, prn
    Indication: Crohn's Disease

Humulin R
    Dosage: 24 units
    Indication: Diabetes Mellitus

Imdur
    Dosage: 30 mg, tid
    Indication: Cardiac Disorder

Lantus
    Dosage: 80 units in the moring and 90 units at night
    Indication: Diabetes Mellitus

Lantus
    Dosage: unk

Methocarbamol
    Indication: Neuropathy Peripheral

Methocarbamol
    Dosage: 750 mg, prn
    Administration route: Oral
    Indication: Muscle Spasms

Nitrostat
    Dosage: 0.4 mg, prn
    Indication: Chest Pain

Norvasc
    Administration route: Oral
    Indication: Palpitations

Potassium Chloride

Potassium Chloride (KV / 24)
    Dosage: 8 meq, qd
    Indication: Blood Potassium

Remeron
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Insomnia

Tylenol
    Dosage: unk unk, qd
    Indication: Migraine

Zantac
    Dosage: 30 mg, tid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral



Possible Zantac side effects in 29 year old female

Reported by a lawyer from United States on 2012-08-23

Patient: 29 year old female

Reactions: Emotional Disorder

Drug(s) suspected as cause:
Flexeril
    Dosage: 10 mg, 1x/day (at hour of sleep)
    Administration route: Oral

Ibuprofen
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    Indication: Pain

Miralax
    Dosage: unk

Topamax
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Grand MAL Convulsion
    Start date: 2005-01-01
    End date: 2007-01-01

Topamax
    Dosage: unk, twice daily
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2007-01-11

Topamax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2007-01-16
    End date: 2007-07-01

Zantac
    Dosage: 150 mg, 2x/day
    Administration route: Oral

Other drugs received by patient: Folic Acid



Possible Zantac side effects in female

Reported by a physician from France on 2012-08-22

Patient: female

Reactions: Respiratory Disorder, Malaise, Erythema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Methylprednisolone
    Dosage: 120mg unknown
    Indication: Premedication
    Start date: 2012-05-18
    End date: 2012-05-18

Plitican
    Dosage: 50mg unknown
    Indication: Premedication
    Start date: 2012-05-18
    End date: 2012-05-18

Polaramine
    Dosage: 5mg unknown
    Indication: Premedication
    Start date: 2012-05-18
    End date: 2012-05-18

Zantac
    Dosage: 50mg unknown
    Indication: Premedication
    Start date: 2012-05-18
    End date: 2012-05-18

Zofran
    Dosage: 8mg per day
    Indication: Premedication
    Start date: 2012-05-18
    End date: 2012-05-18

Other drugs received by patient: 5% Glucose; Taxol; Cisplatin



Possible Zantac side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Dyspepsia

Drug(s) suspected as cause:
Zantac
    Dosage: 150 mg
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2012-08-15
    End date: 2012-08-15

Zantac



Possible Zantac side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: 67 year old female

Reactions: Fatigue, Nausea, Herpes Zoster

Drug(s) suspected as cause:
Ebastine
    Dosage: 10 mg, unk
    Indication: Faecaloma

Ebastine
    Indication: Pruritus

Halaven
    Dosage: unk
    Indication: Faecaloma
    Start date: 2012-06-19

Halaven
    Dosage: 1.58 mg, unk
    Indication: Pruritus
    Start date: 2012-06-26

Loratadine
    Indication: Pruritus

Loratadine
    Indication: Faecaloma

Neulasta
    Indication: Pruritus

Neulasta
    Dosage: unk
    Indication: Faecaloma

Solu-Medrol
    Dosage: 20 mg, unk
    Indication: Faecaloma
    Start date: 2012-06-26

Solu-Medrol
    Indication: Pruritus

Zantac
    Indication: Pruritus

Zantac
    Dosage: 50 mg, unk
    Indication: Faecaloma
    Start date: 2012-06-26

Zofran
    Dosage: 8 mg, unk
    Indication: Faecaloma
    Start date: 2012-06-26

Zofran
    Indication: Pruritus

Other drugs received by patient: Acebutolol; Nexium



Possible Zantac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Dyspepsia

Drug(s) suspected as cause:
Zantac

Other drugs received by patient: Lisinopril



Possible Zantac side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Bedridden, Emphysema, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin

Atenolol
    Administration route: Oral

Ativan
    Administration route: Oral

Depakote
    Administration route: Oral

Dilantin
    Administration route: Oral

Furosemide
    Administration route: Oral

Generlac

Humulin R

Isosorbide Mononitrate

Lantus
    Dosage: 80 iu, qam

Lantus
    Dosage: 90 df, qpm

Lomotil
    Administration route: Oral

Methocarbamol
    Administration route: Oral

Nitrostat

Norvasc
    Administration route: Oral

Potassium Chloride

Remeron
    Administration route: Oral

Tylenol W / Codeine NO. 3

Zantac

Zocor
    Administration route: Oral



Possible Zantac side effects in female

Reported by a consumer/non-health professional from France on 2012-08-21

Patient: female

Reactions: Fatigue, Nausea, Herpes Zoster

Drug(s) suspected as cause:
Ebsatine
    Indication: Faecaloma

Ebsatine
    Indication: Pruritus

Halaven
    Dosage: 1.58 mg/day
    Start date: 2012-06-26

Halaven
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-19

Loratadine
    Indication: Pruritus

Loratadine
    Indication: Faecaloma

Neulasta
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-27

Solu-Medrol
    Dosage: 20 mg/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Zantac
    Dosage: 50 mg/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Zofran
    Dosage: 8 mg/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Other drugs received by patient: Acebutolol; Nexium



Possible Zantac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Accidental Overdose

Drug(s) suspected as cause:
Zantac

Zantac
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2012-08-14
    End date: 2012-08-14



Possible Zantac side effects in female

Reported by a physician from France on 2012-08-20

Patient: female

Reactions: Chest Discomfort, Pruritus, Rash

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 8mg per day
    Indication: Premedication
    Start date: 2012-07-19
    End date: 2012-07-19

Zantac
    Indication: Premedication
    Start date: 2012-07-19
    End date: 2012-07-19

Other drugs received by patient: Epirubicin; Fluorouracil; Cyclophosphamide; Polaramine



Possible Zantac side effects in

Reported by a pharmacist from Japan on 2012-08-20

Patient:

Reactions: Dyspnoea, Blood Pressure Decreased, Shock

Drug(s) suspected as cause:
Zantac



Possible Zantac side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Weight Decreased, Dyspnoea, Diabetes Mellitus, Osteoarthritis, Speech Disorder, Fatigue, Malaise, DRY Mouth, Insomnia, Blood Pressure Inadequately Controlled, Chest Pain, Blood Cholesterol Increased, Venous Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: unk

Atorvastatin
    Dosage: unk

Cardizem
    Dosage: 60 mg, unk

Carvedilol
    Dosage: unk

Clopidogrel

Diovan HCT
    Dosage: 1 tablet (320 mg val/125 mg hct) twice a day
    Indication: Hypertension

Enalapril Maleate
    Dosage: unk

Losartan Potassium
    Dosage: unk
    Indication: Blood Pressure

Metformin Hydrochloride

Omeprazole
    Dosage: unk

Sertraline Hydrochloride
    Dosage: unk

Simvastatin
    Dosage: unk

Topiramate
    Dosage: unk

Zantac
    Dosage: unk

Other drugs received by patient: Clonidine Hydrochloride



Possible Zantac side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Weight Decreased, Dyspnoea, Diabetes Mellitus, Osteoarthritis, Speech Disorder, Fatigue, Malaise, Insomnia, DRY Mouth, Chest Pain, Blood Pressure Inadequately Controlled, Blood Cholesterol Increased, Venous Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: unk

Atorvastatin
    Dosage: unk

Cardizem
    Dosage: 60 mg, unk

Carvedilol
    Dosage: unk

Clopidogrel

Diovan HCT
    Dosage: 1 tablet (320 mg val/125 mg hct) twice a day
    Indication: Hypertension

Enalapril Maleate
    Dosage: unk

Losartan Potassium
    Dosage: unk
    Indication: Blood Pressure

Metformin HCL

Omeprazole
    Dosage: unk

Sertraline Hydrochloride
    Dosage: unk

Simvastatin
    Dosage: unk

Topiramate
    Dosage: unk

Zantac
    Dosage: unk

Other drugs received by patient: Clonidine Hydrochloride



Possible Zantac side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Weight Decreased, Dyspnoea, Diabetes Mellitus, Osteoarthritis, Speech Disorder, Malaise, Fatigue, Insomnia, Chest Pain, Blood Pressure Inadequately Controlled, DRY Mouth, Blood Cholesterol Increased, Venous Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: unk

Atorvastatin
    Dosage: unk

Cardizem
    Dosage: 60 mg, unk

Carvedilol
    Dosage: unk

Clopidogrel

Diovan HCT
    Dosage: 1 tablet (320 mg val/125 mg hct) twice a day
    Indication: Hypertension

Enalapril Maleate
    Dosage: unk

Losartan Potassium
    Dosage: unk
    Indication: Blood Pressure

Metformin Hydrochloride

Omeprazole
    Dosage: unk

Sertraline Hydrochloride
    Dosage: unk

Simvastatin
    Dosage: unk

Topiramate
    Dosage: unk

Zantac
    Dosage: unk

Other drugs received by patient: Clonidine Hydrochloride



Possible Zantac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Zantac



Possible Zantac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Increased Bronchial Secretion

Drug(s) suspected as cause:
Zantac
    Dosage: 300 mg
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-06-01

Zantac
    Indication: Cough



Possible Zantac side effects in female

Reported by a physician from France on 2012-08-17

Patient: female

Reactions: Tongue Oedema, Suffocation Feeling, LIP Oedema, Headache, Erythema, Paraesthesia, Anaphylactoid Reaction, Hypertension, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methylprednisolone
    Dosage: 80mg single dose
    Indication: Premedication
    Start date: 2012-07-11
    End date: 2012-07-11

Zantac
    Dosage: 50mg single dose
    Indication: Premedication
    Start date: 2012-07-11
    End date: 2012-07-11

Other drugs received by patient: Kytril; Polaramine



Possible Zantac side effects in female

Reported by a physician from France on 2012-08-15

Patient: female

Reactions: Fatigue, Pruritus, Nausea, Faecaloma, Herpes Zoster

Drug(s) suspected as cause:
Ebastine
    Indication: Pruritus

Halaven
    Dosage: 1.58mg per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Loratadine
    Indication: Pruritus

Neulasta
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-27

Solu-Medrol
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Zantac
    Dosage: 50mg per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Zofran
    Dosage: 8mg per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Other drugs received by patient: Cyclophosphamide; Fluorouracil; Methotrexate; Nexium; Bevacizumab; Doxorubicin HCL; Acebutolol



Possible Zantac side effects in 1 year old

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 1 year old

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Zantac



Possible Zantac side effects in

Reported by a lawyer from United States on 2012-08-15

Patient:

Reactions: Atrial Septal Defect, Patent Ductus Arteriosus, Ventricular Septal Defect, Maternal Exposure Timing Unspecified, Transposition of THE Great Vessels

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flexeril
    Dosage: 10 mg, unk

Ibuprofen
    Dosage: 600 mg, 3x/day

Miralax
    Dosage: unk

Topiramate
    Dosage: 100 mg, 3x/day
    Start date: 2007-01-16
    End date: 2007-07-01

Zantac
    Dosage: 150 mg, 2x/day

Other drugs received by patient: Folic Acid



Possible Zantac side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: male

Reactions: Dyspepsia

Drug(s) suspected as cause:
Zantac



Possible Zantac side effects in 89 year old male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 89 year old male

Reactions: Pruritus

Drug(s) suspected as cause:
Zantac

Other drugs received by patient: Spiriva; Insulin



Possible Zantac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Disturbance in Attention, Memory Impairment

Drug(s) suspected as cause:
Zantac

Zantac
    Dosage: 150 mg
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2011-08-01
    End date: 2012-07-01

Other drugs received by patient: Lipitor



Possible Zantac side effects in 78 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 78 year old male

Reactions: Musculoskeletal Pain, Musculoskeletal Chest Pain

Drug(s) suspected as cause:
Zantac

Other drugs received by patient: Magnesium Hydroxide TAB



Possible Zantac side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female

Reactions: LOW Birth Weight Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Multi-Vitamins
    Dosage: unknown dosage
    Indication: Pregnancy
    End date: 2012-07-27

Phenergan HCL
    Dosage: prn - as needed dosage
    Indication: Nausea
    End date: 2012-07-27

Subutex
    Indication: Drug Dependence
    Start date: 2011-10-01
    End date: 2012-07-27

Zantac
    Indication: Gastrooesophageal Reflux Disease
    End date: 2012-07-27



Possible Zantac side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: male

Reactions: Faeces Hard

Drug(s) suspected as cause:
Zantac

Zantac
    Dosage: 75 mg
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2012-07-31

Other drugs received by patient: Prilosec; Calcium Carbonate; Tamsulosin HCL



Possible Zantac side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-09

Patient: 71 year old female

Reactions: Palpitations, Nausea, Cold Sweat, Shock

Drug(s) suspected as cause:
Decadron Phosphate
    Dosage: .3mg two times per week
    Start date: 2012-06-07
    End date: 2012-06-07

Decadron Phosphate
    Dosage: .3mg two times per week
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-21
    End date: 2012-06-21

Decadron Phosphate
    Dosage: .3mg two times per week
    Start date: 2012-07-19
    End date: 2012-07-19

Decadron Phosphate
    Dosage: .3mg two times per week

Zantac
    Dosage: 50mg two times per week
    Start date: 2012-07-19
    End date: 2012-07-19

Zantac
    Dosage: 50mg two times per week

Zantac
    Dosage: 50mg two times per week
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-07
    End date: 2012-06-07

Zantac
    Dosage: 50mg two times per week
    Start date: 2012-06-21
    End date: 2012-06-21

Other drugs received by patient: Celestamine TAB; Carboplatin; Paclitaxel; Ramosetron Hydrochloride

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