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Pepcid (Famotidine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pepcid (Famotidine) 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 (117)
Death (7)
Life Threatening Events (5)
Disability (11)

Reports by Reaction Type

Drug Ineffective (10)Abdominal Pain Upper (9)Decreased Appetite (9)Rhabdomyolysis (8)Drug Hypersensitivity (8)Electrolyte Imbalance (7)Dehydration (7)Hepatic Function Abnormal (6)Malaise (6)Dizziness (6)Vomiting (6)Drug Intolerance (6)

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

Possible Pepcid side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Coeliac Disease, Foreign Body

Drug(s) suspected as cause:
Pepcid

Other drugs received by patient: Allopurinol; Atenolol; Immune Globulin (Human); Xanthine; Foradil; Rythmol



Possible Pepcid side effects in

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

Patient:

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine
    Dosage: unk, prn
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-01-01

Pepcid
    Dosage: 30 mg, prn
    Administration route: Oral
    Indication: Gastric Disorder
    Start date: 2011-01-01

Pepcid
    Dosage: 30 mg, prn
    Administration route: Oral
    Indication: Abdominal Pain Upper
    Start date: 2011-01-01
    End date: 2012-01-01



Possible Pepcid side effects in male

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: male, weighing 60.8 kg (133.7 pounds)

Reactions: Abdominal Pain, Product Formulation Issue, Acidosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in

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

Patient:

Reactions: Coeliac Disease, Cardiac Arrest

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in

Reported by a pharmacist from United States on 2012-08-14

Patient:

Reactions: Toxic Epidermal Necrolysis

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in male

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

Patient: male

Reactions: Haematochezia, Gastric Haemorrhage

Drug(s) suspected as cause:
Pepcid

Other drugs received by patient: Celebrex



Possible Pepcid side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Haematochezia

Drug(s) suspected as cause:
Pepcid

Other drugs received by patient: Celebrex



Possible Pepcid side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin

Cefepime

Heparin Sodium

Meropenem

Nitro-DUR

Pepcid
    Administration route: Oral

Piperacillin and Tazobactam

Vancomycin

Zocor
    Administration route: Oral



Possible Pepcid side effects in

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient:

Reactions: Flatulence, Abdominal Distension

Drug(s) suspected as cause:
Pepcid

Other drugs received by patient: Vitamins (Unspecified); Calcium (Unspecified)



Possible Pepcid side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: male

Reactions: Dysgeusia, Nausea, Constipation

Drug(s) suspected as cause:
Pepcid
    Indication: Product Used FOR Unknown Indication

Prilosec
    Indication: Product Used FOR Unknown Indication

Zantac
    Indication: Product Used FOR Unknown Indication



Possible Pepcid side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: male, weighing 79.4 kg (174.6 pounds)

Reactions: Haematochezia, Gastric Haemorrhage

Drug(s) suspected as cause:
Celebrex
    Dosage: unk, 2x/day
    Administration route: Oral
    Indication: Postoperative Care
    Start date: 2000-01-01
    End date: 2000-09-01

Celebrex
    Indication: Headache

Pepcid
    Dosage: unk
    Indication: Dyspepsia



Possible Pepcid side effects in

Reported by a pharmacist from United States on 2012-07-20

Patient:

Reactions: Abdominal Pain, Vomiting, Diarrhoea, Nausea, Dizziness, Gastrooesophageal Reflux Disease, Cough

Drug(s) suspected as cause:
Pepcid

Other drugs received by patient: Xanthophyll; Vitamin E; Vitamins (Unspecified); Altace; Xanax; Anafranil; Omega-3 Marine Triglycerides; Zoloft; Valium; Vistaril



Possible Pepcid side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: 55 year old female

Reactions: Therapeutic Response Unexpected, Haematemesis

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Pepcid

Prevacid

Prilosec
    Administration route: Oral

Zantac



Possible Pepcid side effects in

Reported by a consumer/non-health professional from Japan on 2012-07-17

Patient:

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Enuresis
    Start date: 2012-05-23
    End date: 2012-06-04

Amitriptyline HCL

Chlophedianol Hydrochloride
    Administration route: Oral
    Start date: 2012-05-23

Pepcid
    Administration route: Oral
    Start date: 2012-05-30

PL-Granules
    Administration route: Oral
    Start date: 2012-05-30

Other drugs received by patient: Uritos; Gasmotin; Rebamipide



Possible Pepcid side effects in

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient:

Reactions: Migraine

Drug(s) suspected as cause:
Claritin
    Dosage: unk, unknown

Nasonex
    Dosage: unk, unknown
    Indication: Hypersensitivity

Pepcid
    Dosage: unk, unknown

Zyrtec

Other drugs received by patient: Valium; Topamax



Possible Pepcid side effects in

Reported by a consumer/non-health professional from Japan on 2012-07-12

Patient:

Reactions: Drug Interaction

Drug(s) suspected as cause:
Pepcid

Other drugs received by patient possibly interacting with the suspect drug:
Itraconazole
    Dosage: 50 mg, qd
    Administration route: Oral

Itraconazole
    Dosage: 100 mg, qd
    Administration route: Oral

Other drugs received by patient: MK-9350; Cefcapene Pivoxil Hydrochloride



Possible Pepcid side effects in 22 year old female

Reported by a pharmacist from United States on 2012-06-29

Patient: 22 year old female, weighing 86.0 kg (189.2 pounds)

Reactions: Drug Hypersensitivity, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diphenhydramine HCL
    Dosage: 25 mg;q6h;iv
    Start date: 2012-06-10
    End date: 2012-06-12

Pepcid
    Dosage: 20 mg; iv
    End date: 2012-06-12

Solu-Medrol
    End date: 2012-06-12

Other drugs received by patient: Zantac; Ambien; Fexofenadine; Prednisone



Possible Pepcid side effects in 74 year old female

Reported by a physician from Japan on 2012-06-27

Patient: 74 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in 10 month old female

Reported by a physician from Japan on 2012-06-27

Patient: 10 month old female

Reactions: Drug Ineffective FOR Unapproved Indication, Pfapa Syndrome

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in 5 year old female

Reported by a physician from Japan on 2012-06-27

Patient: 5 year old female

Reactions: Pfapa Syndrome, Drug Ineffective FOR Unapproved Indication

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in 9 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: 9 year old male, weighing 31.8 kg (69.9 pounds)

Reactions: Sleep Disorder, Insomnia

Drug(s) suspected as cause:
Pepcid
    Dosage: pepcid bid oral
    Administration route: Oral
    Start date: 2012-05-26
    End date: 2012-06-06

Risperidone
    Dosage: risperidone bid oral held on 5/29/12
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Risperidone
    Dosage: risperidone bid oral held on 5/29/12
    Administration route: Oral
    Indication: Asperger's Disorder

Other drugs received by patient: Concerta



Possible Pepcid side effects in female

Reported by a pharmacist from Japan on 2012-06-20

Patient: female

Reactions: Off Label Use, Liver Function Test Abnormal

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in 66 year old male

Reported by a pharmacist from Japan on 2012-06-19

Patient: 66 year old male

Reactions: Blood Urea Increased, Blood Creatine Increased

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in 63 year old male

Reported by a physician from Japan on 2012-06-19

Patient: 63 year old male

Reactions: Drug Interaction

Drug(s) suspected as cause:
Itraconazole
    Administration route: Oral

Itraconazole
    Administration route: Oral

Pepcid
    Administration route: Oral

Other drugs received by patient: Cefcapene Pivoxil Hydrochloride; Prednisolone



Possible Pepcid side effects in 63 year old male

Reported by a physician from Japan on 2012-06-14

Patient: 63 year old male

Reactions: Drug Interaction

Drug(s) suspected as cause:
Itraconazole
    Administration route: Oral

Itraconazole
    Administration route: Oral

Pepcid
    Administration route: Oral

Other drugs received by patient: Prednisolone; Cefcapene Pivoxil Hydrochloride



Possible Pepcid side effects in 74 year old female

Reported by a physician from Japan on 2012-06-06

Patient: 74 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pepcid



Possible Pepcid side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female

Reactions: Off Label Use, Irritable Bowel Syndrome, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pepcid
    Administration route: Oral
    Indication: Gastritis

Pepcid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease



Possible Pepcid side effects in 88 year old male

Reported by a consumer/non-health professional from Japan on 2012-05-22

Patient: 88 year old male

Reactions: Myalgia, Rhabdomyolysis, Oculomucocutaneous Syndrome, Urticaria

Drug(s) suspected as cause:
Pepcid
    Administration route: Oral
    Start date: 2012-04-01

Pepcid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-02-01

Other drugs received by patient: Rikkunshi-TO; Marzulene; Depas



Possible Pepcid side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: 71 year old male

Reactions: Inappropriate Schedule of Drug Administration, Urticaria

Drug(s) suspected as cause:
Calcium Carbonate

Pepcid

Prilosec OTC
    Administration route: Oral

Other drugs received by patient: Antihypertensives



Possible Pepcid side effects in 65 year old female

Reported by a pharmacist from Japan on 2012-05-02

Patient: 65 year old female

Reactions: Haemolytic Anaemia

Drug(s) suspected as cause:
Pepcid

Other drugs received by patient: Mononitrate; Cilnidipine; Doxazosin Mesylate; Mesylate Isosorbide

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