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RANITIDINE

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Ranitidine Adverse Events Reported to the FDA Over Time

How are Ranitidine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Ranitidine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Ranitidine is flagged as the suspect drug causing the adverse event.

Most Common Ranitidine Adverse Events Reported to the FDA

What are the most common Ranitidine adverse events reported to the FDA?

Drug Ineffective
1298 (5.28%)
Diarrhoea
412 (1.67%)
Vomiting
404 (1.64%)
Dyspepsia
396 (1.61%)
Nausea
383 (1.56%)
Dyspnoea
377 (1.53%)
Dizziness
295 (1.2%)
Abdominal Pain Upper
289 (1.17%)
Pruritus
240 (.98%)
Headache
226 (.92%)
Chest Pain
214 (.87%)
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Overdose
213 (.87%)
Malaise
212 (.86%)
Rash
197 (.8%)
Urticaria
191 (.78%)
Fatigue
187 (.76%)
Abdominal Pain
186 (.76%)
Hypotension
174 (.71%)
Anaphylactic Reaction
164 (.67%)
Loss Of Consciousness
162 (.66%)
Gastrooesophageal Reflux Disease
155 (.63%)
Drug Screen Positive
154 (.63%)
Pyrexia
153 (.62%)
Drug Exposure During Pregnancy
151 (.61%)
Accidental Overdose
141 (.57%)
Anaphylactic Shock
141 (.57%)
Constipation
140 (.57%)
Medication Error
129 (.52%)
Flatulence
125 (.51%)
Erythema
122 (.5%)
Chest Discomfort
120 (.49%)
Dysgeusia
119 (.48%)
Drug Interaction
113 (.46%)
Abdominal Discomfort
112 (.46%)
Confusional State
112 (.46%)
Insomnia
112 (.46%)
Feeling Abnormal
106 (.43%)
Hypersensitivity
106 (.43%)
Accidental Drug Intake By Child
102 (.41%)
Incorrect Dose Administered
100 (.41%)
Blood Pressure Decreased
99 (.4%)
Circulatory Collapse
97 (.39%)
Asthenia
96 (.39%)
Pain
93 (.38%)
Dry Mouth
92 (.37%)
Anxiety
91 (.37%)
Cardiac Arrest
90 (.37%)
Faeces Discoloured
90 (.37%)
Abdominal Distension
89 (.36%)
Tremor
87 (.35%)
Alanine Aminotransferase Increased
86 (.35%)
Somnolence
86 (.35%)
Condition Aggravated
85 (.35%)
Drug Screen False Positive
85 (.35%)
Tachycardia
85 (.35%)
Blood Pressure Increased
84 (.34%)
Hypertension
82 (.33%)
Pain In Extremity
82 (.33%)
Arthralgia
79 (.32%)
Completed Suicide
79 (.32%)
Convulsion
79 (.32%)
Oxygen Saturation Decreased
79 (.32%)
Burning Sensation
75 (.3%)
Anaemia
74 (.3%)
Neutropenia
74 (.3%)
Aspartate Aminotransferase Increase...
73 (.3%)
Paraesthesia
73 (.3%)
Renal Failure Acute
73 (.3%)
Hyperhidrosis
72 (.29%)
Thrombocytopenia
72 (.29%)
Weight Decreased
72 (.29%)
Drug Effect Decreased
71 (.29%)
Cough
70 (.28%)
Eructation
70 (.28%)
Oedema Peripheral
69 (.28%)
Muscle Spasms
67 (.27%)
Shock
67 (.27%)
Blood Glucose Increased
65 (.26%)
Heart Rate Increased
65 (.26%)
Product Quality Issue
65 (.26%)
Agitation
64 (.26%)
Back Pain
64 (.26%)
Hypoaesthesia
64 (.26%)
Palpitations
63 (.26%)
Swelling Face
63 (.26%)
Throat Irritation
62 (.25%)
Pneumonia
60 (.24%)
Cyanosis
59 (.24%)
Drug Hypersensitivity
59 (.24%)
Myalgia
59 (.24%)
Flushing
57 (.23%)
Respiratory Arrest
57 (.23%)
Rhabdomyolysis
57 (.23%)
Dysphagia
56 (.23%)
Glossodynia
55 (.22%)
Vision Blurred
54 (.22%)
Angioedema
53 (.22%)
Lethargy
53 (.22%)
Depressed Level Of Consciousness
51 (.21%)
Urine Amphetamine Positive
50 (.2%)
Alopecia
49 (.2%)

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This graph shows the top adverse events submitted to the FDA for Ranitidine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Ranitidine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Ranitidine

What are the most common Ranitidine adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Ranitidine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Ranitidine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Ranitidine According to Those Reporting Adverse Events

Why are people taking Ranitidine, according to those reporting adverse events to the FDA?

Gastrooesophageal Reflux Disease
2678
Dyspepsia
2664
Drug Use For Unknown Indication
2075
Product Used For Unknown Indication
1469
Premedication
902
Prophylaxis
850
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Gastritis
516
Gastric Disorder
385
Prophylaxis Against Gastrointestina...
330
Gastric Ulcer
282
Abdominal Pain Upper
189
Ulcer
167
Abdominal Discomfort
159
Ill-defined Disorder
149
Hyperchlorhydria
133
Hiatus Hernia
112
Gastritis Prophylaxis
107
Antacid Therapy
83
Gastrointestinal Disorder
77
Peptic Ulcer
75
Nausea
73
Reflux Oesophagitis
62
Duodenal Ulcer
61
Abdominal Pain
49
Rheumatoid Arthritis
46
Flatulence
45
Oesophagitis
43
Stomach Discomfort
40
Pain
38
Vomiting
38
Barretts Oesophagus
35
Urticaria
33
Gastric Ph Decreased
30
Chemotherapy
29
Hypersensitivity
29
Crohns Disease
26
Prophylaxis Of Nausea And Vomiting
24
Nervousness
22
Reflux Gastritis
21
Chest Pain
19
Hernia
19
Acne
18
Pruritus
17
Drug Exposure During Pregnancy
17
Gastrointestinal Disorder Therapy
17
Irritable Bowel Syndrome
16
Constipation
16
Gastrooesophageal Reflux Prophylaxi...
16
Breast Cancer
16
Pancreatitis
15
Duodenitis
14

Drug Labels

LabelLabelerEffective
Ranitidine HydrochlorideBryant Ranch Prepack22-OCT-97
Ranitidine 75Major Pharmaceuticals01-JUL-09
Ranitidine Dr. Reddy's Laboratories Limited26-AUG-09
Formucare RanitidineAccess Business Group International LLC09-SEP-09
RanitidinePD-Rx Pharmaceuticals, Inc.02-NOV-09
RanitidineAmneal Pharmaceuticals16-DEC-09
Ranitidine PD-Rx Pharmaceuticals, Inc.16-DEC-09
RanitidineBryant Ranch Prepack16-DEC-09
Ranitidine PD-Rx Pharmaceuticals, Inc.16-DEC-09
Ranitidine Rebel Distributors17-DEC-09
RanitidineMcKesson Packaging Services Business Unit of McKesson Corporation22-DEC-09
RanitidineContract Pharmacy Services-PA11-MAR-10
RanitidineBedford Laboratories15-MAR-10
RanitidineBedford Laboratories17-MAR-10
RanitidineActavis Mid Atlantic LLC28-MAR-10
RanitidineWOCKHARDT USA LLC.02-APR-10
RanitidineWOCKHARDT USA LLC.02-APR-10
RanitidineState of Florida DOH Central Pharmacy13-APR-10
Ranitidine HydrochlorideState of Florida DOH Central Pharmacy13-APR-10
RanitidineState of Florida DOH Central Pharmacy13-APR-10
RanitidineState of Florida DOH Central Pharmacy01-JUN-10
RanitidinePharmaceutical Associates, Inc.03-JUN-10
Ranitidine HydrochlorideKeltman Pharmaceuticals Inc.03-JUN-10
RanitidineAmneal Pharmaceuticals15-JUN-10
RanitidineContract Pharmacy Services-PA30-JUN-10
RanitidineMajor Pharmaceuticals30-JUL-10
RanitidineAurobindo Pharma Limited02-AUG-10
RanitidinePhysicians Total Care, Inc.17-AUG-10
RanitidineWOCKHARDT LIMITED17-AUG-10
RanitidineWOCKHARDT USA LLC17-AUG-10
Ranitidine HydrochlorideREMEDYREPACK INC. 25-OCT-10
Ranitidine HydrochlorideRebel Distributors Corp11-NOV-10
RanitidineSandoz Inc.17-NOV-10
Ranitidine REMEDYREPACK INC. 06-DEC-10
ZantacefferdoseGlaxoSmithKline LLC18-JAN-11
ZantacGlaxoSmithKline LLC18-JAN-11
Ranitidine HydrochlorideREMEDYREPACK INC. 14-APR-11
ZantacGlaxoSmithKline LLC04-MAY-11
ZantacGlaxoSmithKline LLC04-MAY-11
RanitidineCardinal Health18-MAY-11
Ranitidine HydrochlorideCardinal Health25-MAY-11
RanitidineUnit Dose Services06-JUN-11
RanitidineUnit Dose Services06-JUN-11
RanitidineGlenmark Generics Inc., USA06-JUN-11
Ranitidine HydrochlorideREMEDYREPACK INC. 11-AUG-11
RanitidineQualitest Pharmaceuticals19-AUG-11
RanitidineShasun Pharmaceuticals Limited27-SEP-11
Ranitidine HydrochlorideREMEDYREPACK INC. 03-OCT-11
Ranitidine Caraco Pharmaceutical Laboratories, Ltd.03-OCT-11
Ranitidine HydrochlorideSandoz Inc17-OCT-11
Ranitidine HydrochlorideDr. Reddy's Laboratories Limited18-OCT-11
RanitidineDr. Reddy's Laboratories Limited18-OCT-11
RanitidineMcKesson Contract Packaging07-NOV-11
RanitidineWOCKHARDT LIMITED15-NOV-11
RanitidineWOCKHARDT LIMITED21-NOV-11
Ranitidine HydrochlorideREMEDYREPACK INC. 12-JAN-12
RanitidineWOCKHARDT USA LLC13-JAN-12
RanitidineWOCKHARDT LIMITED13-JAN-12
Ranitidine HydrochlorideMylan Institutional Inc.03-FEB-12
Ranitidine HydrochloridePrecision Dose Inc.21-FEB-12
RanitidinePreferred Pharmaceuticals, Inc27-FEB-12
RanitidineShasun Pharmaceuticals Limited29-FEB-12
Ranitidine Par Pharmaceutical Inc08-MAR-12
RanitidineNCS HealthCare of KY, Inc dba Vangard Labs13-MAR-12
RanitidineCardinal Health29-MAR-12
RanitidineAmerican Health Packaging16-APR-12
RanitidineSTAT Rx USA LLC03-MAY-12
RanitidinePhysicians Total Care, Inc.24-MAY-12
Ranitidine HydrochlorideDr. Reddy's Laboratories Limited20-JUN-12
RanitidineCardinal Health03-JUL-12
RanitidineHi-Tech Pharmacal Co., Inc.11-JUL-12
Ranitidine - Acid ReducerOhm Laboratories Inc.18-JUL-12
Ranitidine - Acid ReducerOhm Laboratories Inc.19-JUL-12
Ranitidine - Acid ReducerPremier Value30-JUL-12
ZantacCardinal Health02-AUG-12
Healthy Accents RanitidineDZA Brands LLC09-AUG-12
RanitidineShopko Stores Operating Co., LLC.29-AUG-12
RanitidineIVAX Pharmaceuticals, Inc.30-AUG-12
RanitidineChain Drug Marketing Association Inc.10-SEP-12
RanitidineChain Drug Marketing Association Inc.11-SEP-12
Up And Up RanitidineTarget Corporation19-SEP-12
Formu Care RanitidineAccess Business Group LLC27-SEP-12
Ranitidine HydrochlorideSelect Brand28-SEP-12
RanitidineSTAT Rx USA LLC02-OCT-12
RanitidineSelect Brand03-OCT-12
RanitidineAidarex Pharmaceuticals LLC08-OCT-12
RanitidineMcKesson Packaging Services Business Unit of McKesson Corporation06-NOV-12
Ranitidine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs14-NOV-12
RanitidineLake Erie Medical DBA Quality Care Products LLC16-NOV-12
RanitidineWOCKHARDT USA LLC.12-DEC-12
RanitidineWOCKHARDT LIMITED12-DEC-12
RanitidineSilarx Pharmaceuticals, Inc21-DEC-12
RanitidineFred's Inc.07-JAN-13
RanitidineWal-Mart Stores, Inc22-JAN-13
RanitidineValu Merchandisers Company31-JAN-13
RanitidineValu Merchandisers Company31-JAN-13
RanitidineLake Erie Medical DBA Quality Care Products LLC01-FEB-13
RanitidineShopko Stores Operating Co., LLC07-FEB-13
Ranitidine HydrochlorideCadila Healthcare Limited01-MAR-13
Ranitidine HydrochlorideZydus Pharmaceuticals (USA) Inc.01-MAR-13
ZantacCovis Pharmaceuticals, Inc.15-MAR-13
ZantacCovis Pharmaceuticals, Inc.15-MAR-13
RanitidineMedline Industries, Inc.26-MAR-13
RanitidineREMEDYREPACK INC. 26-MAR-13
RanitidineCardinal Health01-APR-13
RanitidineP and L Development of New York Corporation05-APR-13
Acid ReducerP and L Development of New York Corporation09-APR-13
Ranitidine HydrochlorideCardinal Health18-APR-13
RanitidineCardinal Health30-APR-13

Ranitidine Case Reports

What Ranitidine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Ranitidine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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