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Iron Adverse Events Reported to the FDA Over Time

How are Iron adverse event reports trending over time?

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

Most Common Iron Adverse Events Reported to the FDA

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

Dyspnoea
66 (2.27%)
Completed Suicide
49 (1.68%)
Nausea
46 (1.58%)
Drug Exposure During Pregnancy
45 (1.55%)
Infusion Related Reaction
41 (1.41%)
Back Pain
39 (1.34%)
Vomiting
32 (1.1%)
Abdominal Pain
30 (1.03%)
Diarrhoea
30 (1.03%)
Hypotension
30 (1.03%)
Dizziness
28 (.96%)
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Chest Pain
27 (.93%)
Anaemia
25 (.86%)
Drug Interaction
21 (.72%)
Fatigue
21 (.72%)
Pain
21 (.72%)
Pruritus
21 (.72%)
Anaphylactic Reaction
20 (.69%)
Headache
20 (.69%)
Multiple Drug Overdose
20 (.69%)
Hypersensitivity
19 (.65%)
Blood Pressure Increased
18 (.62%)
Medication Error
18 (.62%)
Somnolence
18 (.62%)
Acute Hepatic Failure
17 (.58%)
Hepatic Necrosis
17 (.58%)
Muscle Spasms
17 (.58%)
Pain In Extremity
17 (.58%)
Rash
17 (.58%)
Constipation
16 (.55%)
Drug Ineffective
16 (.55%)
Hyperhidrosis
16 (.55%)
Premature Baby
16 (.55%)
Heart Rate Increased
15 (.52%)
Maternal Drugs Affecting Foetus
15 (.52%)
Urticaria
15 (.52%)
Weight Increased
15 (.52%)
Arthralgia
14 (.48%)
Pyrexia
14 (.48%)
Asthenia
13 (.45%)
Cardio-respiratory Arrest
13 (.45%)
Paraesthesia
13 (.45%)
Alanine Aminotransferase Increased
12 (.41%)
Hepatic Enzyme Increased
12 (.41%)
Oedema Peripheral
12 (.41%)
Pneumonia
12 (.41%)
Tachycardia
12 (.41%)
Tremor
12 (.41%)
Anxiety
11 (.38%)
Aspartate Aminotransferase Increase...
11 (.38%)
Death
11 (.38%)
Flushing
11 (.38%)
Gastrointestinal Haemorrhage
11 (.38%)
Iron Deficiency Anaemia
11 (.38%)
Pulmonary Embolism
11 (.38%)
Syncope
11 (.38%)
Blood Pressure Decreased
10 (.34%)
Chills
10 (.34%)
Cough
10 (.34%)
Drug Hypersensitivity
10 (.34%)
Erythema
10 (.34%)
Gastrointestinal Disorder
10 (.34%)
Haemoglobin Decreased
10 (.34%)
Hypoaesthesia
10 (.34%)
Musculoskeletal Stiffness
10 (.34%)
Myalgia
10 (.34%)
Poisoning
10 (.34%)
Talipes
10 (.34%)
Abdominal Distension
9 (.31%)
Aspergillosis
9 (.31%)
Depression
9 (.31%)
Dysphagia
9 (.31%)
Gait Disturbance
9 (.31%)
Liver Disorder
9 (.31%)
Loss Of Consciousness
9 (.31%)
Platelet Count Decreased
9 (.31%)
Abdominal Pain Upper
8 (.27%)
Brain Death
8 (.27%)
Cardiac Arrest
8 (.27%)
Chest Discomfort
8 (.27%)
Cholestasis
8 (.27%)
Coma
8 (.27%)
Confusional State
8 (.27%)
Convulsion
8 (.27%)
Drug Toxicity
8 (.27%)
Hypertension
8 (.27%)
Septic Embolus
8 (.27%)
Weight Decreased
8 (.27%)
Burning Sensation
7 (.24%)
Cerebral Haemorrhage
7 (.24%)
Faeces Discoloured
7 (.24%)
General Physical Health Deteriorati...
7 (.24%)
Liver Injury
7 (.24%)
Mental Disorder
7 (.24%)
Multiple Drug Overdose Intentional
7 (.24%)
Musculoskeletal Pain
7 (.24%)
Overdose
7 (.24%)
Rash Pruritic
7 (.24%)
Suicidal Ideation
7 (.24%)
Abdominal Discomfort
6 (.21%)
Anaphylactic Shock
6 (.21%)

ExportShare/Embed GraphExport Export Data

This graph shows the top adverse events submitted to the FDA for Iron, 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 Iron 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 Iron

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

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This graph shows the top categories of adverse events submitted to the FDA for Iron, 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 Iron 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 Iron According to Those Reporting Adverse Events

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

Product Used For Unknown Indication
1154
Anaemia
1089
Drug Use For Unknown Indication
1028
Mineral Supplementation
442
Iron Deficiency Anaemia
170
Supplementation Therapy
137
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Iron Deficiency
130
Blood Iron Decreased
99
Medical Diet
96
Vitamin Supplementation
59
Anaemia Prophylaxis
55
Prophylaxis
48
Haemoglobin Decreased
42
Crohns Disease
40
Dialysis
35
Routine Health Maintenance
34
Pregnancy
32
Drug Exposure During Pregnancy
32
Paroxysmal Nocturnal Haemoglobinuri...
26
Nutritional Support
21
Ill-defined Disorder
12
Fatigue
11
Renal Failure Chronic
10
Serum Ferritin Decreased
10
Gastrointestinal Haemorrhage
10
Pernicious Anaemia
9
Haemodialysis
8
Thrombosis Prophylaxis
7
Haemorrhage
7
Blood Count Abnormal
7
Red Blood Cell Count Decreased
7
Nephrogenic Anaemia
6
Rheumatoid Arthritis
5
Foetal Exposure During Pregnancy
5
Suicide Attempt
5
Blood Iron
5
Renal Disorder
4
Blood Iron Abnormal
4
Blood Disorder
4
Restless Legs Syndrome
4
Colitis Ulcerative
4
Inflammatory Bowel Disease
4
Haematocrit Decreased
4
Folate Deficiency
4
Prostate Cancer
4
Surgery
3
Haemolysis
3
Deficiency Anaemia
3
Gastric Bypass
3
Type 2 Diabetes Mellitus
3
Ulcer Haemorrhage
3

Drug Labels

LabelLabelerEffective
Iron ChewsMidlothian Laboratories23-NOV-09
InfedWatson Pharma, Inc.16-DEC-09
BiferarxAlaven Pharmaceutical LLC31-MAR-10
Ferralet 90Mission Pharmacal Company26-FEB-11
Multi Vitamin, Iron And FluorideLibertas Pharma, Inc.21-MAY-11
Multi-vitamin Fluoride And Iron DropsBoca Pharmacal, Inc.10-JUN-11
InfedGeneral Injectables & Vaccines, Inc13-JUN-11
Tri-vit With Fluoride And Iron DropsQualitest Pharmaceuticals22-JUL-11
NatafortMission Pharmacal Company10-AUG-11
DexferrumAmerican Regent, Inc.02-SEP-11
Ferraplus 90TRIGEN Laboratories, Inc.23-SEP-11
Escavite GM Pharmaceuticals, Inc.29-MAR-12
Viva Ct PrenatalJayMac Pharmaceuticals LLC03-MAY-12
Natelle OneJazz Pharmaceuticals Commercial Corp.29-JUN-12
VenoferFresenius Medical Care North America28-SEP-12
VenoferAmerican Regent, Inc.28-SEP-12
Hemetab WH Nutritionals, LLC15-OCT-12
Meteoric Iron Prunus Immune SupportUriel Pharmacy Inc30-OCT-12
Eros Iron ManMEGASOL COSMETIC GMBH04-DEC-12
BiferarxMeda Pharmaceuticals Inc.04-DEC-12
Multi-vit With Fluoride And IronQualitest Pharmaceuticals12-DEC-12
Citranatal Harmony 2.1Mission Pharmacal Company14-DEC-12
Prenatal Plus IronMajor Pharmaceuticals14-DEC-12
Marvel Iron Man 3 Hand Sanitizer Blue Cross Laboratories, Inc.04-JAN-13
Tl-fluoriviteTrigen Laboratories, Inc.30-JAN-13

Iron Case Reports

What Iron 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 Iron. 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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