July 2009 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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 July 2009, FDA received 28,323 drug adverse event reports. In July 2008, FDA received 26,560.

In July 2009, FDA received 19,114 medical device reports. In July 2008, FDA received 16,792.

By drug reports received, July 2009 was number 6 of the 12 months of 2009. FDA received 26,038 drug reports a month on average in the 12 months before July 2009.

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 July 2009

Drugs in the reports

The table has the 72 drug pages with 100 or more reports in July 2009. 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports of July 2009 name as a suspect product, in order of name
Drug	Reports in the month
Aclasta	104
Advair Hfa	105
Aleve	142
Aspirin	169
Avandia	961
Avastin	121
Avelox	147
Avonex	717
Bevacizumab	165
Boniva	169
Byetta	152
Bystolic	119
Capecitabine	136
Carboplatin	133
Chantix	112
Cisplatin	137
Clozaril	137
Coumadin	884
Crestor	121
Cyclophosphamide	184
Cyclosporine	114
Cymbalta	163
Dianeal	253
Digoxin	179
Diovan	163
Doxorubicin hydrochloride	119
Duragesic-100	201
Enbrel	287
Exelon	102
Exjade	134
Fentanyl Transdermal System	100
Flomax	100
Flovent	152
Fluorouracil	116
Forteo	203
Gleevec	149
Humira	368
Keppra	112
Lamotrigine	124
Lantus	178
Lyrica	140
Methotrexate	122
Mirena	1,052
Mycophenolate mofetil	115
Nexium	119
Opcon-A	134
Paxil	122
Plavix	157
Prednisolone	117
Prednisone	198
Premarin	285
Prempro	220
Procrit	209
Provera	290
Rebif	190
Remicade	343
Revlimid	269
Risperdal	135
Rituximab	148
Seroquel	605
Simvastatin	108
Singulair	128
Soliris	244
Tiotropium bromide	344
Tykerb	163
Tysabri	459
Velcade	103
Warfarin sodium	126
Xolair	108
Yaz	269
Zometa	130
Zyprexa	165

Reaction terms in the reports

The table has the 68 reaction terms with 250 or more reports in July 2009. 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Reaction terms that the drug reports of July 2009 record, in order of name
Reaction term (MedDRA) and plain meaning	Reports in the month
Abdominal painstomach or belly pain	453
Abdominal pain upperupper stomach pain	290
Adverse eventan unwanted medical event, type not specified	292
Anaemialow red blood cells	451
Anxietyanxiety	440
Arthralgiajoint pain	450
Astheniaweakness or lack of energy	652
Back painback pain	330
Blood glucose increasedraised blood sugar reading	252
Cardiac failure congestivecongestive heart failure	269
Cerebrovascular accidentstroke	306
Chest painchest pain	486
Condition aggravatedthe condition being treated got worse	341
Confusional stateconfusion	382
Convulsion	536
Coughcough	280
Deaththe patient died; cause not stated by this term	922
Decreased appetitereduced appetite	340
Dehydrationdehydration	304
Depressionlow mood	520
Diabetes mellitusdiabetes	439
Diarrhoealoose or frequent stools	781
Dizzinesslight-headedness or unsteadiness	846
Drug exposure during pregnancythe medicine was taken during pregnancy	395
Drug ineffectivethe medicine did not work as expected	813
Drug interactionan interaction between medicines	370
Dyspnoeashortness of breath	985
Falla fall	537
Fatiguetiredness	841
Feeling abnormalfeeling odd or not right	304
Gait disturbancedifficulty walking	286
Haemoglobin decreasedlow haemoglobin	269
Headachehead pain	781
Hypersensitivityan allergic-type reaction	255
Hypertensionhigh blood pressure	372
Hypoaesthesianumbness	272
Hypotensionlow blood pressure	387
Injurya physical injury	250
Insomniadifficulty sleeping	405
Intra-uterine contraceptive device expelled	348
Loss of consciousnesspassing out	311
Malaisegeneral feeling of being unwell	473
Multiple sclerosis relapsea flare of multiple sclerosis	273
Muscle spasmsmuscle cramps	275
Myalgiamuscle pain	335
Myocardial infarctionheart attack	406
Nauseafeeling sick	1,121
Oedema peripheralswelling of the legs, ankles or hands	412
Overdosea dose above the recommended amount	298
Painpain, site not specified	619
Pain in extremitypain in an arm or leg	373
Paraesthesiatingling or pins and needles	275
Pneumonialung infection	492
Product quality issuea problem with the product itself	250
Product substitution issuea problem after switching products	339
Pruritusitching	377
Pyrexiafever	760
Rashskin rash	477
Renal failurekidney failure	420
Renal failure acute	315
Sepsisa severe body-wide response to infection	268
Somnolencedrowsiness	323
Tremorshaking	338
Urinary tract infectionbladder or urinary infection	254
Urticariahives	260
Vomitingbeing sick	801
Weight decreasedweight loss	381
Weight increasedweight gain	365

Devices in the reports

The table has the 55 device pages with 50 or more reports in July 2009. 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 2 Oct 2026.

Device brand names that the device reports of July 2009 name, in order of name
Brand name	Reports in the month
634 Affinity Bed 405	67
840 Ventilator	57
Accu-Chek Aviva Test Strips	112
Accu-Chek Comfort Curve Test Strips	139
Accu-Chek Compact Test Drum	67
Accu-Chek Spirit	201
Cell-Dyn 1800 Analyzer	52
Centra Bed	64
Contour Test Strips 50	58
Cypher Sirolimus-Eluting Coronary Stent	74
Dextrus 4136	76
Dura Star Rx Ptca Balloon Catheter	78
Durata Sts Optim Active Fixation	78
E Series Defibrillator	57
Fluorostar	58
FreeStyle Lite	424
Ge Oec 9600	54
Ge Oec 9800	276
Ge Oec 9900	156
Harmonic Ace 36cm W Erg Handle	77
HiRes 90K	50
Inratio	63
Lead Model 302	82
Lifepak 20 Defibrillator/Monitor	68
Lifevest Wcd 3000 System	108
Ligamax-5mm Endo Clip Applier	60
M Series	175
Nucleus 24 Channel Cochlear Implant System	72
OmniPod Insulin Pump	111
One Touch Ping Meter	235
One Touch Ultra Meter	54
One Touch Ultralink Meter	230
Perclose Proglide 6f Suture Mediated Closure Smc System	78
Precision?	121
Programming Software	51
Protime Microcoagulation System	59
Pump Mmt-722nas Prdgm Ins V2 2 Sk En	81
Restore Ultra	53
Riata Active Fixation	88
Soletra	73
Starclose Se Vascular Closure System	52
Stenoscope	62
Synchromed El	54
Synergy	63
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	56
Taxus Liberte Paclitaxel-Eluting Coronary Stent System	103
Tendril Sdx	78
Tendril St	77
Totalcare	133
Totalcare-Treat Surface&scale Total Care Frame	62
Transtar Stretcher	63
Vasoview Hemopro Endoscopic Vessel Harvesting System	54
Ventak Prizm 2	57
Versacare Bed Versacare Frame	81
Xience V Everolimus Eluting Coronary Stent System	100

Cite this page

Reported Reactions. July 2009: adverse event reports received by FDA. https://reportedreactions.com/month/2009-07/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

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 July 2009 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: 28,323 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 2 Oct 2026.

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.

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