Reported Reactions

Adverse event reports that FDA received

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February 2007 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 February 2007, FDA received 20,336 drug adverse event reports. In February 2006, FDA received 22,513.

In February 2007, FDA received 11,987 medical device reports. In February 2006, FDA received 9,527.

By drug reports received, February 2007 was number 7 of the 12 months of 2007. FDA received 20,129 drug reports a month on average in the 12 months before February 2007.

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 February 2007
025,00050,000200520062007

Drugs in the reports

The table has the 67 drug pages with 50 or more reports in February 2007. 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 February 2007 name as a suspect product, in order of name
DrugReports in the month
Accutane165
Acetaminophen50
Angiomax78
Apokyn73
Aspirin78
Avastin117
Avonex219
Betaseron77
Bextra206
Byetta3,058
Carboplatin76
Celebrex107
Chantix102
Cisplatin73
Coumadin63
Cyclophosphamide83
Cymbalta85
Dexamethasone51
Diovan62
Enbrel186
Evista88
Fluorouracil65
Forteo136
Fosamax78
Gleevec51
Glucophage194
Humira153
Ibuprofen64
Imitrex271
Isotretinoin62
Januvia531
Lamictal1,725
Lantus65
Levaquin54
Levemir192
Lipitor107
Lisinopril64
Lyrica173
Metformin hcl90
Methotrexate103
Mirena373
Nexavar132
Novolog63
Oxaliplatin60
Paroxetine hydrochloride206
Paxil543
Peg-Intron57
Plavix91
Prednisone66
Premarin52
Rebif99
Remicade293
Revlimid100
Ribavirin57
Risperdal67
Rozerem202
Seroquel121
Seroxat226
Sutent52
Valtrex482
Velcade54
Venlafaxine hydrochloride50
Warfarin sodium86
Xolair66
Zocor110
Zometa142
Zyprexa134

Reaction terms in the reports

The table has the 119 reaction terms with 100 or more reports in February 2007. 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 February 2007 record, in order of name
Reaction term (MedDRA) and plain meaningReports in the month
Abdominal distensiona bloated abdomen174
Abdominal painstomach or belly pain260
Abdominal pain upperupper stomach pain216
Abortion spontaneousmiscarriage108
Aggressionaggressive behaviour181
Agitationrestlessness133
Alanine aminotransferase increasedraised liver enzyme (ALT)153
Alopeciahair loss138
Amnesiamemory loss131
Anaemialow red blood cells209
Anorexia239
Anxietyanxiety329
Arthralgiajoint pain224
Aspartate aminotransferase increasedraised liver enzyme (AST)149
Astheniaweakness or lack of energy430
Back painback pain162
Balance disorderproblems with balance109
Blood creatinine increasedraised creatinine, a kidney test119
Blood glucose decreasedlow blood sugar reading467
Blood glucose increasedraised blood sugar reading1,542
Blood pressure decreaseda low blood pressure reading111
Blood pressure increaseda raised blood pressure reading157
Cardiac arrestthe heart stopped108
Cardio-respiratory arrestthe heart and breathing stopped135
Cerebrovascular accidentstroke250
Chest discomfortchest discomfort108
Chest painchest pain233
Chillschills or shivering159
Completed suicidedeath by suicide258
Condition aggravatedthe condition being treated got worse301
Confusional stateconfusion248
Constipationconstipation213
Convulsion325
Coughcough156
Deaththe patient died; cause not stated by this term566
Decreased appetitereduced appetite470
Deep vein thrombosisa blood clot in a deep vein101
Dehydrationdehydration187
Depressed level of consciousness102
Depressionlow mood345
Diabetes mellitusdiabetes110
Diarrhoealoose or frequent stools610
Dizzinesslight-headedness or unsteadiness713
Drug effect decreasedthe medicine had less effect196
Drug exposure during pregnancythe medicine was taken during pregnancy305
Drug ineffectivethe medicine did not work as expected982
Drug interactionan interaction between medicines231
Drug toxicity105
Drug withdrawal syndromesymptoms on stopping a medicine484
Dysgeusiaaltered taste133
Dyspepsiaindigestion166
Dysphagiadifficulty swallowing108
Dyspnoeashortness of breath504
Erythemaskin redness164
Falla fall300
Fatiguetiredness524
Feeling abnormalfeeling odd or not right356
Gait disturbancedifficulty walking140
Haemoglobin decreasedlow haemoglobin127
Headachehead pain669
Heart rate increaseda fast heart rate reading168
Hyperhidrosisexcessive sweating258
Hypersensitivityan allergic-type reaction178
Hypertensionhigh blood pressure202
Hypoaesthesianumbness152
Hypoglycaemialow blood sugar136
Hypotensionlow blood pressure241
Influenza like illnessflu-like symptoms116
Injection site bruisingbruising where the injection was given168
Injection site haemorrhagebleeding where the injection was given116
Injection site painpain where the injection was given182
Insomniadifficulty sleeping321
Irritabilityirritability100
Loss of consciousnesspassing out231
Malaisegeneral feeling of being unwell291
Medication errora mistake in prescribing, dispensing or taking a medicine254
Memory impairmentmemory problems109
Muscle spasmsmuscle cramps138
Muscular weaknessmuscle weakness115
Myalgiamuscle pain202
Myocardial infarctionheart attack255
Nasopharyngitisa cold101
Nauseafeeling sick1,577
Nervousnessnervousness102
Neutropenialow neutrophils, a type of white blood cell107
Oedema peripheralswelling of the legs, ankles or hands215
Osteonecrosis146
Overdosea dose above the recommended amount210
Painpain, site not specified300
Pain in extremitypain in an arm or leg183
Palpitationsawareness of the heartbeat121
Pancreatitisinflammation of the pancreas121
Paraesthesiatingling or pins and needles188
Pharmaceutical product complaint368
Platelet count decreasedlow platelet count132
Pneumonialung infection267
Pruritusitching339
Pulmonary embolisma blood clot in the lung130
Pyrexiafever420
Rashskin rash814
Renal failurekidney failure204
Renal failure acute241
Rhabdomyolysismuscle breakdown149
Sepsisa severe body-wide response to infection124
Somnolencedrowsiness285
Stevens-Johnson syndromea severe skin and mucous-membrane reaction127
Suicidal ideationthoughts of suicide174
Suicide attempta suicide attempt173
Syncopefainting137
Tachycardiafast heart rate119
Thrombocytopenialow platelets141
Tremorshaking362
Urticariahives164
Uterine perforationa hole in the wall of the womb169
Vision blurredblurred vision169
Vomitingbeing sick768
Weight decreasedweight loss1,330
Weight increasedweight gain250
White blood cell count decreasedlow white cell count115

Devices in the reports

The table has the 57 device pages with 25 or more reports in February 2007. 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 February 2007 name, in order of name
Brand nameReports in the month
840 Ventilator40
Accu-Chek Aviva Test Strips40
Accu-Chek Comfort Curve Test Strips234
Accu-Chek Compact Test Drum76
Aed Plus48
Animas Insulin Infusion Pump46
CADD Medication Cassette Reservoir25
Coaguchek S System80
Collamer Ultraviolet-Absorbing Posterior Chamber Three Piece28
Contak Renewal151
Contak Renewal 3286
Contak Renewal 3 Rf82
Contak Renewal 3 Rf He57
Contak Renewal 428
Cypher Sirolimus-Eluting Coronary Stent205
Endotak Reliance99
Endotak Reliance G127
Flextend Is-1 Bi Positive Fix143
Freestyle258
Freestyle Flash620
Ge Oec 980062
Ge Oec 990026
GORE EXCLUDER AAA Endoprosthesis29
Harmonic Ace 36 Cm48
HiRes 90K27
Indura37
Inratio48
Insignia Entra25
Insignia Plus50
Insignia Ultra44
Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large35
M Series171
Maverick2 Monorail Ptca Catheter52
Medtronic29
Microstaar Injector28
Microstaar Injector Cartridge28
Nucleus 24 Channel Cochlear Implant System41
Ortho Summit Sample Handling System33
Ot Ultra Meter43
Precision?52
Rsvr Prdgm38
Silicone Advance Optic Lens35
Silicone Ultraviolet-Absorbing Posterior Chamber Three Piece25
Softclix Lancet Device33
Softclix Plus Lancet Device26
Starclose Vascular Closure System167
Synchromed El60
Taxus Express2 Paclitaxel-Eluting Coronary Stent System190
Tension Free Vaginal Tape46
Ultracision Harmonic Ace29
Ultraflex Infusion Set49
Vitality 2 Vr35
Vitality Avt141
Vitality Avt Fast-Charge34
Vitality Ds64
Vitality Ds Vr39
Vitality Vr46

Cite this page

Reported Reactions. February 2007: adverse event reports received by FDA. https://reportedreactions.com/month/2007-02/ 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 February 2007 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: 20,336 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.