Reported Reactions

Adverse event reports that FDA received

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October 2006 adverse event reports that FDA received in the month

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports received

In October 2006, FDA received 18,944 drug adverse event reports. In October 2005, FDA received 22,584.

In October 2006, FDA received 9,446 medical device reports. In October 2005, FDA received 8,015.

By drug reports received, October 2006 was number 7 of the 12 months of 2006. FDA received 19,499 drug reports a month on average in the 12 months before October 2006.

Receive date

A month is the month in which FDA first received the report, not the month of the event. A report about an event of an earlier year is in the month in which it came to FDA.

Data version

FAERS release of 29 Oct 2026. MAUDE release of 23 Oct 2026.

Drug reports, three years

Drug reports that FDA received each month, 36 months to October 2006
025,00050,000200420052006

Drugs in the reports

The table has the 86 drug pages with 50 or more reports in October 2006. The rows are in order of name. A drug page with fewer reports is not in the table.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Drugs that the reports of October 2006 name as a suspect product, in order of name
DrugReports in the month
Abciximab74
Abilify53
Actos55
Advair Diskus 100/5050
Advair Hfa1,693
Aspirin121
Avapro164
Avastin105
Avonex313
Betaseron80
Bextra406
Boniva57
Byetta79
Capecitabine64
Carboplatin91
Celebrex370
Chantix57
Cipro51
Cisplatin84
Crestor50
Cubicin51
Cyclophosphamide118
Cyclosporine65
Cymbalta111
Dexamethasone91
Diovan55
Doxorubicin hydrochloride66
Duragesic-10051
Enbrel208
Fluorouracil86
Forteo206
Fosamax74
Geodon52
Gleevec69
Humalog65
Humira107
Ibuprofen56
Kenalog-4052
Ketek61
Lamictal76
Levemir207
Lexapro63
Lipitor180
Lisinopril78
Lunesta618
Lyrica592
Methadone hydrochloride55
Methotrexate91
Mirena67
Neurontin476
Orencia105
Oxaliplatin84
Paxil111
Peg-Intron81
Pegasys70
Plavix80
Prednisolone66
Prednisone87
Premarin263
Provera83
Rebif54
Remicade296
Reteplase83
Revlimid121
Ribavirin66
Risperdal77
Salmeterol xinafoate99
Sensipar54
Seroquel94
Simvastatin51
Stromectol75
Sutent115
Taxol67
Taxotere59
Temodar53
Thalomid77
Velcade71
Ventavis84
Viagra53
Vincristine53
Vioxx293
Warfarin sodium79
Zocor53
Zoloft62
Zometa232
Zyprexa269

Reaction terms in the reports

The table has the 145 reaction terms with 100 or more reports in October 2006. The rows are in order of name. One report can record more than one term.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Reaction terms that the drug reports of October 2006 record, in order of name
Reaction term (MedDRA) and plain meaningReports in the month
Abdominal painstomach or belly pain252
Abdominal pain upperupper stomach pain182
Aggressionaggressive behaviour107
Agitationrestlessness144
Alanine aminotransferase increasedraised liver enzyme (ALT)260
Alopeciahair loss100
Amnesiamemory loss143
Anaemialow red blood cells259
Anorexia188
Anxietyanxiety253
Arthralgiajoint pain268
Aspartate aminotransferase increasedraised liver enzyme (AST)241
Astheniaweakness or lack of energy455
Asthmaasthma188
Atrial fibrillationan irregular heart rhythm127
Back painback pain189
Balance disorderproblems with balance105
Blood alkaline phosphatase increased113
Blood bilirubin increased107
Blood creatine phosphokinase increased135
Blood creatinine increasedraised creatinine, a kidney test189
Blood glucose increasedraised blood sugar reading282
Blood pressure decreaseda low blood pressure reading102
Blood pressure increaseda raised blood pressure reading208
Bradycardiaslow heart rate110
Breast cancerbreast cancer175
Cardiac arrestthe heart stopped207
Cardiac disorder108
Cardiac failureheart failure143
Cardiac failure congestivecongestive heart failure163
Cardiovascular disorder110
Cerebrovascular accidentstroke345
Chest discomfortchest discomfort134
Chest painchest pain297
Chillschills or shivering156
Coma148
Completed suicidedeath by suicide153
Condition aggravatedthe condition being treated got worse484
Confusional stateconfusion312
Constipationconstipation157
Convulsion335
Coughcough283
Deaththe patient died; cause not stated by this term336
Deep vein thrombosisa blood clot in a deep vein110
Dehydrationdehydration283
Depressed level of consciousness141
Depressionlow mood292
Diabetes mellitusdiabetes178
Diarrhoealoose or frequent stools484
Disease progressionthe disease advanced112
Disorientation123
Dizzinesslight-headedness or unsteadiness625
Drug effect decreasedthe medicine had less effect104
Drug exposure during pregnancythe medicine was taken during pregnancy415
Drug hypersensitivityan allergic-type reaction (the term names a medicine)124
Drug ineffectivethe medicine did not work as expected1,206
Drug interactionan interaction between medicines273
Drug toxicity136
Drug withdrawal syndromesymptoms on stopping a medicine115
Dry mouthdry mouth107
Dysgeusiaaltered taste338
Dysphagiadifficulty swallowing135
Dysphoniaa hoarse voice227
Dyspnoeashortness of breath801
Erythemaskin redness164
Falla fall397
Fatiguetiredness468
Feeling abnormalfeeling odd or not right241
Gait disturbancedifficulty walking193
Gamma-glutamyltransferase increased110
Gastrointestinal haemorrhagebleeding in the stomach or bowel113
General physical health deteriorationgeneral decline in health161
Haematocrit decreased105
Haemoglobin decreasedlow haemoglobin241
Haemorrhagebleeding148
Hallucinationseeing or hearing things that are not there129
Headachehead pain513
Heart rate increaseda fast heart rate reading227
Hyperhidrosisexcessive sweating198
Hypersensitivityan allergic-type reaction164
Hypertensionhigh blood pressure297
Hypoaesthesianumbness156
Hypoglycaemialow blood sugar118
Hyponatraemialow blood sodium116
Hypotensionlow blood pressure331
Incorrect dose administeredthe wrong dose was given124
Infectionan infection, type not specified122
Infusion related reactiona reaction during or soon after an infusion113
Injurya physical injury118
Insomniadifficulty sleeping445
International normalised ratio increasedblood clotting slower than intended (raised INR)109
Ischaemic stroke114
Loss of consciousnesspassing out344
Malaisegeneral feeling of being unwell344
Malignant neoplasm progression110
Medication errora mistake in prescribing, dispensing or taking a medicine218
Muscle spasmsmuscle cramps238
Muscular weaknessmuscle weakness152
Myalgiamuscle pain231
Myocardial infarctionheart attack367
Nauseafeeling sick670
Neutropenialow neutrophils, a type of white blood cell163
Oedema peripheralswelling of the legs, ankles or hands281
Osteonecrosis153
Overdosea dose above the recommended amount204
Painpain, site not specified383
Pain in extremitypain in an arm or leg245
Palpitationsawareness of the heartbeat161
Pancytopenialow counts of all blood cells113
Paraesthesiatingling or pins and needles169
Pharmaceutical product complaint856
Pharyngolaryngeal pain125
Platelet count decreasedlow platelet count192
Pleural effusionfluid around the lung147
Pneumonialung infection263
Pruritusitching257
Pulmonary embolisma blood clot in the lung167
Pulmonary oedemafluid in the lungs103
Pyrexiafever533
Rashskin rash380
Renal failurekidney failure289
Renal failure acute215
Respiratory arrestbreathing stopped148
Respiratory failurethe lungs could not supply enough oxygen143
Rhabdomyolysismuscle breakdown113
Sepsisa severe body-wide response to infection181
Somnolencedrowsiness338
Stevens-Johnson syndromea severe skin and mucous-membrane reaction112
Suicidal ideationthoughts of suicide272
Suicide attempta suicide attempt308
Syncopefainting170
Tachycardiafast heart rate187
Therapy non-responderthe treatment did not work100
Thrombocytopenialow platelets199
Thrombosis107
Tremorshaking265
Urinary tract infectionbladder or urinary infection124
Urticariahives157
Vision blurredblurred vision221
Visual disturbance117
Vomitingbeing sick547
Weight decreasedweight loss240
Weight increasedweight gain278
White blood cell count decreasedlow white cell count153
White blood cell count increased105

Devices in the reports

The table has the 50 device pages with 25 or more reports in October 2006. The rows are in order of name. A device page with fewer reports is not in the table.

FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Device brand names that the device reports of October 2006 name, in order of name
Brand nameReports in the month
840 Ventilator38
Accu-Chek Aviva Test Strips25
Accu-Chek Comfort Curve83
Accu-Chek Comfort Curve Test Strips234
Accu-Chek Compact Test Drum62
Aed Plus30
Animas Insulin Infusion Pump54
Biohorizons External Dental Implant117
Biohorizons Internal Dental Implant73
Capd Solution Transfer Set Short For Uv-Flash33
Coaguchek S System89
Contour Test Strips 5028
Cypher Sirolimus-Eluting Coronary Stent146
D-Tronplus Power Pack32
Easy Load Inserter45
Freestyle25
Freestyle Flash89
Freestyle Mini30
Ge Oec 980027
H-Tronplus35
Harmonic Ace 36 Cm43
HiRes 90K44
Inratio42
Lifepak Cr Plus Defibrillator30
Ligamax 547
M Series158
Maverick2 Monorail Ptca Catheter30
MED-EL Combi 40+ Cochlear Implant System33
Mtome St Holster/Cables25
Nucleus 24 Channel Cochlear Implant System30
Ortho Provue Analyzer32
Ortho Summit Sample Handling System35
Ot Ultra Meter83
Precision?31
Pulmonetic25
Renu With Moistureloc Multi-Purpose Solution29
Riata Active-Fixation Lead31
Rsvr Prdgm52
Rx Acculink Carotid Stent System25
Silicone Advance Optic Lens49
Silicone Ultraviolet-Absorbing Posterior Chamber Three Piece28
Soflex Three-Piece Foldable Lens33
Softclix Lancet Device30
Synchromed El61
Taxus Express2 Drug-Eluting Coronary Stent36
Taxus Express2 Paclitaxel-Eluting Coronary St55
Taxus Express2 Paclitaxel-Eluting Coronary Stent132
Thermophore Automatic Moist Heat Pack25
Ultracision Harmonic Ace54
Ultraflex Infusion Set30

Cite this page

Reported Reactions. October 2006: adverse event reports received by FDA. https://reportedreactions.com/month/2006-10/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The device counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Can the count for October 2006 change?

Yes. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases. This page has the count of the openFDA release of 29 Oct 2026: 18,944 drug reports.

Does a month with many reports mean that something occurred in that month?

Not by itself. The date is the date on which FDA received the report, not the date of the event. FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.