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Vioxx Side Effects

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Common Vioxx Side Effects


The most commonly reported Vioxx side effects (click to view or check a box to report):

Myocardial Infarction (11089)
Cerebrovascular Accident (10746)
Chest Pain (6158)
Coronary Artery Disease (5600)
Hypertension (3958)
Depression (3820)
Cardiac Disorder (3619)
Anxiety (3312)
Acute Myocardial Infarction (3014)
Angina Pectoris (2958)
Cardiac Failure Congestive (2686)
Cardiovascular Disorder (2322)
Dyspnoea (2087)
Blood Cholesterol Increased (2031)
Back Pain (1781)
Arthropathy (1777)
Angina Unstable (1635)
Anaemia (1471)
Dizziness (1467)
Atrial Fibrillation (1459)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Vioxx Side Effects Reported to FDA



Vioxx Side Effect Report#9820304
Myocardial Infarction
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Vioxx (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vioxx treatment in female patients, resulting in Myocardial Infarction side effect.
Vioxx Side Effect Report#9353709
Cardiac Failure
This report suggests a potential Vioxx Cardiac Failure side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Vioxx (dosage: 1 Tablet, Daily, Po) starting
Nov 13, 2003. After starting Vioxx the patient began experiencing various side effects, including: Cardiac FailureAdditional drugs used concurrently: NA. Although Vioxx demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure, may still occur.
Vioxx Side Effect Report#9336840
Cardiac Arrest, Troponin Increased, Chest Pain
This Cardiac Arrest problem was reported by a consumer or non-health professional from FR. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: musculoskeletal pain. On
Jan 16, 2004 this consumer started treatment with Vioxx (dosage: 1 Df, Qd). The following drugs were being taken at the same time: NA. When using Vioxx, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Troponin Increased, Chest PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Vioxx Side Effect Report#9319316
Cerebrovascular Accident, Chest Pain, Dyspnoea
This Cerebrovascular Accident side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Vioxx (drug dosage: 25 Mg Twice), which was initiated on NS. Concurrently used drugs: NA..After starting to take Vioxx the consumer reported adverse symptoms, such as: Cerebrovascular Accident, Chest Pain, DyspnoeaThese side effects may potentially be related to Vioxx. The patient was hospitalized and became disabled.
Vioxx Side Effect Report#9312859
Dermatitis Allergic
This is a report of a 65-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Vioxx (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dermatitis Allergic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vioxx treatment in female patients, resulting in Dermatitis Allergic side effect.
Vioxx Side Effect Report#9312818
Local Swelling
This report suggests a potential Vioxx Local Swelling side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Vioxx (dosage: NA) starting NS. After starting Vioxx the patient began experiencing various side effects, including: Local SwellingAdditional drugs used concurrently: NA. Although Vioxx demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Local Swelling, may still occur.
Vioxx Side Effect Report#9291052
Cardiac Valve Disease, Arrhythmia, Endocarditis, Arteriosclerosis Coronary Artery, Myocardial Ischaemia, Coronary Artery Bypass, Colectomy, Aortic Valve Replacement, Endocarditis
This Cardiac Valve Disease problem was reported by a consumer or non-health professional from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On
Sep 05, 2000 this consumer started treatment with Vioxx (dosage: 25 Mg, Qd). The following drugs were being taken at the same time: NA. When using Vioxx, the patient experienced the following unwanted symptoms/side effects: Cardiac Valve Disease, Arrhythmia, Endocarditis, Arteriosclerosis Coronary Artery, Myocardial Ischaemia, Coronary Artery Bypass, Colectomy, Aortic Valve Replacement, EndocarditisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Valve Disease, may become evident only after a product is in use by the general population.
Vioxx Side Effect Report#9262353
Hypertension
This Hypertension side effect was reported by a consumer or non-health professional from US. A 33-year-old female patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Vioxx (drug dosage: 2x), which was initiated on
Jun 01, 2004. Concurrently used drugs: NA..After starting to take Vioxx the consumer reported adverse symptoms, such as: HypertensionThese side effects may potentially be related to Vioxx.
Vioxx Side Effect Report#9207699
Lacunar Infarction, Troponin, Cerebrovascular Accident, Dysphagia, Failure To Thrive, Cardiopulmonary Failure, Myocardial Infarction, Type 2 Diabetes Mellitus, Hypersensitivity
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Vioxx (dosage: 25 Mg, Bid, start time:
Jan 23, 2003), combined with: NA. and developed a serious reaction and side effect(s): Lacunar Infarction, Troponin, Cerebrovascular Accident, Dysphagia, Failure To Thrive, Cardiopulmonary Failure, Myocardial Infarction, Type 2 Diabetes Mellitus, Hypersensitivity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vioxx treatment in female patients, resulting in Lacunar Infarction side effect. The patient was hospitalized.
Vioxx Side Effect Report#9114165
Cerebrovascular Accident, Carotid Artery Occlusion, Convulsion, Renal Failure, Carotid Bruit, Cholelithiasis, Renal Impairment, Insomnia, Nausea
This report suggests a potential Vioxx Cerebrovascular Accident side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: epicondylitis,arthralgia and used Vioxx (dosage: 30 Unk, Unk) starting
Dec 12, 2000. After starting Vioxx the patient began experiencing various side effects, including: Cerebrovascular Accident, Carotid Artery Occlusion, Convulsion, Renal Failure, Carotid Bruit, Cholelithiasis, Renal Impairment, Insomnia, NauseaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Vioxx demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Vioxx Side Effect Report#9110478
Chest Pain
This Chest Pain problem was reported by a physician from Country Not Specified. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: arthralgia,fatigue. On 200204 this consumer started treatment with Vioxx (dosage: 25 Mg, Qd, Patient Took 112 Tablets In All). The following drugs were being taken at the same time: NA. When using Vioxx, the patient experienced the following unwanted symptoms/side effects: Chest PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chest Pain, may become evident only after a product is in use by the general population.
Vioxx Side Effect Report#9097458
Transient Ischaemic Attack, Complicated Migraine, Osteoarthritis, Osteoarthritis, Respiratory Fume Inhalation Disorder, Convulsion, Chest Pain, Complex Partial Seizures, Simple Partial Seizures
This Transient Ischaemic Attack side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: osteoarthritis,pain.The patient was prescribed Vioxx (drug dosage: 25-50), which was initiated on
Feb 17, 2004. Concurrently used drugs: NA..After starting to take Vioxx the consumer reported adverse symptoms, such as: Transient Ischaemic Attack, Complicated Migraine, Osteoarthritis, Osteoarthritis, Respiratory Fume Inhalation Disorder, Convulsion, Chest Pain, Complex Partial Seizures, Simple Partial SeizuresThese side effects may potentially be related to Vioxx. The patient was hospitalized.
Vioxx Side Effect Report#9085405
Myocardial Infarction, Coronary Artery Disease
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: inflammation, who was treated with Vioxx (dosage: Unk, start time: 2002), combined with: NA. and developed a serious reaction and side effect(s): Myocardial Infarction, Coronary Artery Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vioxx treatment in male patients, resulting in Myocardial Infarction side effect.
Vioxx Side Effect Report#9032653
Hypersensitivity
This report suggests a potential Vioxx Hypersensitivity side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Vioxx (dosage: Unk) starting NS. After starting Vioxx the patient began experiencing various side effects, including: HypersensitivityAdditional drugs used concurrently: NA. Although Vioxx demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypersensitivity, may still occur.
Vioxx Side Effect Report#9017648
Cerebrovascular Accident, Grand Mal Convulsion, Renal Injury, Haemorrhage, Dehydration, Anaemia, Hypertension
This Cerebrovascular Accident problem was reported by a health professional from US. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis,blood pressure. On 1999 this consumer started treatment with Vioxx (dosage: 25 Mg, Bid). The following drugs were being taken at the same time:
  • Verapamil
When using Vioxx, the patient experienced the following unwanted symptoms/side effects: Cerebrovascular Accident, Grand Mal Convulsion, Renal Injury, Haemorrhage, Dehydration, Anaemia, HypertensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebrovascular Accident, may become evident only after a product is in use by the general population.
Vioxx Side Effect Report#8607852
Osteoporosis, Multiple Fractures, Back Pain, Cardiac Disorder, Gallbladder Disorder, Spinal Cord Disorder, Spinal Compression Fracture, Bone Density Decreased, Extraskeletal Ossification
This Osteoporosis side effect was reported by a consumer or non-health professional from US. A 39-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vioxx (drug dosage: NA), which was initiated on
Jan 30, 2001. Concurrently used drugs:
  • Hydroco/apap/norco (5-500 Mg Four To Six Hours As Needed)
  • Guiafenesin
  • Hyoscyamine (0.125 Mg Take One Tablet Every Two Hours As Needed)
  • Esgic (One Capsule)
  • Prozac
  • Striant
  • Tagamet
  • Tums
.After starting to take Vioxx the consumer reported adverse symptoms, such as: Osteoporosis, Multiple Fractures, Back Pain, Cardiac Disorder, Gallbladder Disorder, Spinal Cord Disorder, Spinal Compression Fracture, Bone Density Decreased, Extraskeletal OssificationThese side effects may potentially be related to Vioxx. The patient was hospitalized and became disabled.
Vioxx Side Effect Report#8543318-3
Mastication Disorder, Neoplasm Malignant, Breast Cancer Recurrent, Metastases To Mouth, Joint Stiffness, Fistula Discharge, Deformity, Pain
This is a report of a 50-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Vioxx (dosage: NA, start time:
Apr 01, 2001), combined with:
  • Advair Hfa
  • Xeloda
  • Femara
  • Lorazepam
  • Gemzar
  • Oxycontin
  • Percocet
  • Flonase
and developed a serious reaction and side effect(s): Mastication Disorder, Neoplasm Malignant, Breast Cancer Recurrent, Metastases To Mouth, Joint Stiffness, Fistula Discharge, Deformity, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vioxx treatment in female patients, resulting in Mastication Disorder side effect.
Vioxx Side Effect Report#8456640-6
Colitis Ulcerative, Irritable Bowel Syndrome, Depression, Stress, Inflammatory Bowel Disease, Intestinal Obstruction
This report suggests a potential Vioxx Colitis Ulcerative side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Vioxx (dosage: NA) starting
Jan 01, 1997. After starting Vioxx the patient began experiencing various side effects, including: Colitis Ulcerative, Irritable Bowel Syndrome, Depression, Stress, Inflammatory Bowel Disease, Intestinal ObstructionAdditional drugs used concurrently:
  • Zoloft
  • Accutane
  • Accutane
The patient was hospitalized. Although Vioxx demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Colitis Ulcerative, may still occur.
Vioxx Side Effect Report#8456577-2
Haemorrhagic Anaemia, Dry Eye, Asthma, Hyperglycaemia, Tendonitis, Fat Necrosis, Osteonecrosis, Herpes Zoster
This Haemorrhagic Anaemia problem was reported by a physician from United States. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoarthritis,hypercholesterolaemia,osteoporosis,osteopenia. On
Jan 01, 1995 this consumer started treatment with Vioxx (dosage: NA). The following drugs were being taken at the same time:
  • Zetia
  • Fosamax
  • Fosamax
When using Vioxx, the patient experienced the following unwanted symptoms/side effects: Haemorrhagic Anaemia, Dry Eye, Asthma, Hyperglycaemia, Tendonitis, Fat Necrosis, Osteonecrosis, Herpes ZosterThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhagic Anaemia, may become evident only after a product is in use by the general population.
Vioxx Side Effect Report#8448723-1
Colitis Ulcerative, Irritable Bowel Syndrome, Stress, Depression, Inflammatory Bowel Disease, Intestinal Obstruction
This Colitis Ulcerative side effect was reported by a consumer or non-health professional from United States. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vioxx (drug dosage: NA), which was initiated on
Jan 01, 1997. Concurrently used drugs:
  • Accutane
  • Zoloft
  • Accutane
.After starting to take Vioxx the consumer reported adverse symptoms, such as: Colitis Ulcerative, Irritable Bowel Syndrome, Stress, Depression, Inflammatory Bowel Disease, Intestinal ObstructionThese side effects may potentially be related to Vioxx.
Vioxx Side Effect Report#8419405-7
Cardiovascular Disorder, Cardiac Failure Congestive, Cardiac Disorder
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Vioxx (dosage: NA, start time:
Sep 19, 2000), combined with:
  • Plaquenil
  • Lipitor
  • Methotrexate
  • Avandia (4mg Per Day)
  • Glucotrol Xl
  • Hydrochlorothiazide
  • Monopril
and developed a serious reaction and side effect(s): Cardiovascular Disorder, Cardiac Failure Congestive, Cardiac Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vioxx treatment in female patients, resulting in Cardiovascular Disorder side effect. The patient was hospitalized.
Vioxx Side Effect Report#8396495-1
Erectile Dysfunction, Dyspepsia, Autoimmune Thrombocytopenia, Behcet's Syndrome, Libido Decreased
This report suggests a potential Vioxx Erectile Dysfunction side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Vioxx (dosage: NA) starting
Apr 13, 2004. After starting Vioxx the patient began experiencing various side effects, including: Erectile Dysfunction, Dyspepsia, Autoimmune Thrombocytopenia, Behcet's Syndrome, Libido DecreasedAdditional drugs used concurrently:
  • Celebrex
  • Celebrex
  • Celebrex
  • Celebrex
  • Celebrex
The patient was hospitalized and became disabled. Although Vioxx demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Erectile Dysfunction, may still occur.
Vioxx Side Effect Report#8371235-0
Stress Fracture, Fracture Displacement, Spinal Compression Fracture, Paraesthesia, Foot Fracture, Osteoarthritis, Radiculopathy, Synovial Cyst, Fracture Nonunion
This Stress Fracture problem was reported by a health professional from United States. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 13, 2000 this consumer started treatment with Vioxx (dosage: NA). The following drugs were being taken at the same time:
  • Roxicet
  • Levaquin
  • Protonix
  • Ethedent (sodium Fluoride)
  • Loprox (ciclopirox Olamine)
  • Zovirax /00587301/ (aciclovir)
  • Zithromax
  • Actonel (30 Mg, Oral)
When using Vioxx, the patient experienced the following unwanted symptoms/side effects: Stress Fracture, Fracture Displacement, Spinal Compression Fracture, Paraesthesia, Foot Fracture, Osteoarthritis, Radiculopathy, Synovial Cyst, Fracture NonunionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stress Fracture, may become evident only after a product is in use by the general population.
Vioxx Side Effect Report#8341194-5
Meningioma, Creutzfeldt-jakob Disease
This Meningioma side effect was reported by a physician from United States. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vioxx (drug dosage: NA), which was initiated on
Dec 01, 2001. Concurrently used drugs:
  • Hydrocodone Bitartrate + Acetaminophen
.After starting to take Vioxx the consumer reported adverse symptoms, such as: Meningioma, Creutzfeldt-jakob DiseaseThese side effects may potentially be related to Vioxx. The patient was hospitalized.
Vioxx Side Effect Report#8312517-8
Cough, Raynaud's Phenomenon, Musculoskeletal Stiffness, Adenoidal Disorder, Atelectasis, Arthritis, Vitiligo, Foot Deformity, Body Height Decreased
This is a report of a 63-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: back pain,osteoporosis, who was treated with Vioxx (dosage: NA, start time:
Jan 01, 1987), combined with:
  • Fosamax
  • Fosamax
and developed a serious reaction and side effect(s): Cough, Raynaud's Phenomenon, Musculoskeletal Stiffness, Adenoidal Disorder, Atelectasis, Arthritis, Vitiligo, Foot Deformity, Body Height Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vioxx treatment in female patients, resulting in Cough side effect. The patient was hospitalized and became disabled.


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The appearance of Vioxx on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Vioxx Side Effects for Women?

Women Side EffectsReports
Cerebrovascular Accident 6216
Myocardial Infarction 4611
Chest Pain 3111
Coronary Artery Disease 2068
Depression 1990
Hypertension 1969
Anxiety 1699
Cardiac Disorder 1666
Cardiac Failure Congestive 1478
Angina Pectoris 1384

What are common Vioxx Side Effects for Men?

Men Side EffectsReports
Myocardial Infarction 6462
Cerebrovascular Accident 4522
Coronary Artery Disease 3531
Chest Pain 3044
Hypertension 1989
Cardiac Disorder 1951
Acute Myocardial Infarction 1949
Depression 1830
Anxiety 1613
Angina Pectoris 1574

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Vioxx reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    How Effective is Vioxx for You?

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    Vioxx Safety Alerts, Active Ingredients, Usage Information

    More About Vioxx

    Side Effects reported to FDA: 32842

    Vioxx safety alerts: 2005 2004 2002

    Reported deaths: 6027

    Reported hospitalizations: 26659

    COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

    Audience: Healthcare professionals and consumers

    FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.

    [June 15, 2005 - Drug Information Page - FDA]
    [June 15, 2005 - Medication Guide - FDA-Approved]

    Latest Vioxx clinical trials