Lareb Database

Vanuit de website van het Farmacotherapeutisch Kompas bent u direct op de pagina van het bijwerkingencentrum lareb gekomen. U vindt hier onder "Wat is er gemeld bij Lareb" een overzicht van meldingen van de vermoede bijwerkingen van het door u gezochte middel. Ook vindt u meer informatie over publicaties en bevindingen van Lareb. Na afloop kunt u deze pagina sluiten om direct terug te gaan naar de website van het Farmacotherapeutisch Kompas .

FAMOTIDINE

  Attention: The results shown, apply for the ATC-group of drugs to which FAMOTIDINE belongs. Click here for a complete overview of these drugs.
The below shown drugs belong to the same group (based on ATC code).

ATC-code Drug Form
A02BA03 FAMOGAST (FAMOTIDINE) Tablet
A02BA03 FAMOSIN (FAMOTIDINE) Tablet
A02BA03 FAMOTIDINE Tablet
A02BA03 MAAGZUURREMMER () Tablet
A02BA03 PEPCIDIN (FAMOTIDINE) Tablet

Click for more information about:

Publications Lareb

Publications, both in English and in Dutch, by the Netherlands Pharmacovigilance Centre Lareb

No information available.
Signals

Signals as submitted to Lareb to the Dutch Medicines Evaluation Board. Some of the articles are in Dutch only.

No information available.
Overview of reports submitted to Lareb

To ensure a correct interpretation of the results, the data shown may only be used for publications or other media after consulting Lareb. Please read the disclaimer.

The reports shown on this website were received directly by the Netherlands Pharmacovigilance Centre Lareb. If you enter a brand name or generic name, all reports of products will be shown that contain the corresponding active substance. The selection that is shown is based on the ATC classification system of the World Health Organization.

The fact that a possible side effect of a drug or vaccine is reported, does not imply that the reported symptoms are actually caused by the drug or vaccine. Since the aim of a voluntary reporting centre is to detect new adverse drug reactions, we ask healthcare professionals and consumers to report suspicions of ADRs, even if the causal relationship has not been proven.

One single report may refer to multiple ADRs For this reason, the number of reports may be higher than the number of reports shown in the overview.

The number of reports shown does not necessarily reflect the actual change for an ADR to occur. It is therefore not possible to calculate an incidence rate of these ADRs based on these data.

Most recent update: 10/1/2022.

FAMOTIDINE

Number of reports 57
Serious 2
Gender
Male
Female
24
(42%)
33
(58%)
Age
 
Year received
Calender year of reporting.
 
Year ADR
Calender year in which the possible ADR occured. If more events have been reported, the year in which the first event occurred is shown. Before 2002 the date, on which the report was received, was noted instead of the date of occurrence of the possible adverse drug reaction. For these reports the year in which the reaction actually occurred is not always known.
 
Reporter
 

Overview of reported side effects

Click on a side effect for more specific information

Cardiac : 3
Arrhythmia : 2
Atrioventricular block complete : 1
Eye : 1
Dry eye : 1
Gastrointestinal : 30
Eructation : 1
Abdominal pain : 6
Diarrhoea : 4
Dry mouth : 6
Swollen tongue : 1
Gastrointestinal pain : 1
Gastrointestinal sounds abnormal : 1
Nausea : 4
Constipation : 4
Abdominal distension : 1
Flatulence : 1
General disorders and administr. Site : 19
Feeling abnormal : 1
Pyrexia : 2
Chills : 1
Asthenia : 1
Malaise : 3
Therapeutic response unexpected : 3
Pain : 1
Therapeutic response decreased : 1
Fatigue : 6
Hepatobiliary : 1
Hepatocellular injury : 1
Investigations : 1
Prothrombin time prolonged : 1
Metabolism and nutrition : 1
Decreased appetite : 1
Musculoskeletal and connective tissue : 8
Arthralgia : 3
Pain in extremity : 2
Flank pain : 1
Back pain : 1
Myalgia : 1
Nervous system : 22
Dizziness : 8
Memory impairment : 1
Headache : 8
Somnolence : 3
Paraesthesia : 1
Hypoaesthesia : 1
Psychiatric : 9
Anxiety : 1
Depressed mood : 1
Disorientation : 1
Hallucination : 1
Loss of libido : 1
Listless : 1
Nightmare : 1
Insomnia : 1
Confusional state : 1
Renal and urinary tracts : 1
Micturition urgency : 1
Reproductive system and breasts : 3
Breast enlargement : 1
Erectile dysfunction : 1
Vaginal discharge : 1
Respiratory and thoracic : 3
Apnoea : 1
Dry throat : 1
Pharyngeal swelling : 1
Skin and subcutaneous tissue : 6
Angioedema : 2
Alopecia : 1
Pruritus : 1
Rash erythematous : 1
Rosacea : 1
Vascular : 1
Haematoma : 1
Overview of reports submitted to EMA
All reports submitted to EMA can be found here.
Overview of reports submitted to World Health Organization

VigiBase® data

This data is sourced from VigiBase, the World Health Organization’s (the “WHO”) global database for suspected adverse drug reactions “ADRs”, maintained by Uppsala Monitoring Centre (“UMC”). UMC is the WHO Collaborating Centre for International Drug Monitoring based in Uppsala, Sweden providing scientific leadership and operative support to the WHO Program for International Drug Monitoring (www.who-umc.org).

The data contains reports of suspected ADRs, so called Individual Case Safety Reports (ICSRs), collected by national drug authorities in over 120 countries and span over more than 100 000 different medicinal products. Thus, this database is only a repository of ICSRs provided for VigiBase, and shall not be considered as a systematic register of ADRs that have occurred or may occur.

The volume of ICSRs for a particular medicinal product may be influenced by many different factors, including but not limited to the extent of use of the product, publicity and the nature of the reactions. No information is provided on the number of patients exposed to a particular product, and it is therefore, based on the ICSRs, not possible to calculate frequency of any ADR. Moreover, collection of data is, due to e.g. differing national legislation and policies, heterogeneous between different countries. For these reasons, any interpretation of ADR data, and particularly those based on comparisons between various medicinal products, may be misleading.

Information on a suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use. Any robust conclusion with regard to benefits and risks of a specific medicinal product always requires detailed evaluation and scientific assessment of all available data. The balance between benefit and risk of a specific medicinal product also varies between individual patients.

If you think that you may be experiencing a side-effect from a medicinal product, please seek advice from a health professional as soon as possible. Never stop or change the dose for prescription medicines without consulting your physician.

About the release of this data:
UMC takes great care to ensure that the data contained herein is an accurate record of data collected by the national drug authorities and transmitted to UMC. UMC does, however, not guarantee, warrant or make any representation whatsoever regarding the data contained herein, including but not limited to guarantees, warranties or representations of accuracy, reliability, completeness, currency, suitability, fitness or usefulness for any particular purpose or with respect to non-infringement of any third-party rights. In no event shall UMC be liable for any loss, damage, cost or other expense whatsoever (whether direct, indirect, punitive, incidental, special or consequential) arising out of or in any way connected with the use of or reference to any data contained herein. In no event shall UMC be liable other than i) under Swedish substantive law and ii) subject to the courts of Sweden with the district court of Uppsala as first instance.

FAMOTIDINE

Number of reports 16,550
Gender
Female
Male
Unknown
9,283
(56%)
6,200
(37%)
1,067
(6%)
Age
Year received
Region
Africa
Americas
Asia
Europe
Oceania
112
(1%)
7,477
(45%)
6,877
(42%)
1,647
(10%)
437
(3%)

Overview of reported side effects



Blood and lymphatic system : 873
Cardiac : 669
Congenital and genetic disorders : 20
Ear and labyrinth : 149
Endocrine system : 34
Eye : 341
Gastrointestinal : 4,174
General disorders and administr. Site : 3,714
Hepatobiliary : 486
Immune system : 502
Infections and infestations : 344
Injury and poisoning : 1,505
Investigations : 1,051
Metabolism and nutrition : 352
Musculoskeletal and connective tissue : 493
Neoplasms : 72
Nervous system : 2,679
Pregnancy and perinatal conditions : 55
Product issues : 208
Psychiatric : 1,303
Renal and urinary tracts : 412
Reproductive system and breasts : 268
Respiratory and thoracic : 919
Skin and subcutaneous tissue : 2,996
Social circumstances : 13
Surgical and medical procedures : 47
Vascular : 486
Related drugs and vaccines
If you want to search for related substances, you can choose from the list presented here.

# ATC-code Drug Form
1 A02BA01 CIMETIDINE Tablet
2 A02BA02 RANITIDINE Drank, Injectie/infuus
3 A02BA02 ZANTAC (RANITIDINE) Injectievloeistof
4 A02BA04 AXID (NIZATIDINE) Capsule
5 A02BA04 NIZATIDINE Capsule
6 A02BA06 ROXATIDINE Overige toedieningsvormen
7 A02BA07 RANITIDINEBISMUTCITRAAT Overige toedieningsvormen
8 A02BA51 CIMETIDINE, COMBINATIEPREPARATEN Overige toedieningsvormen