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Voltaren Side Effects

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Common Voltaren Side Effects


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

Off Label Use (255)
Dyspnoea (171)
Therapeutic Response Unexpected (136)
Blood Creatinine Increased (129)
Aspartate Aminotransferase Increased (122)
Pain (115)
Alanine Aminotransferase Increased (114)
Nausea (114)
Pyrexia (112)
Erythema (108)
Blood Urea Increased (108)
Dizziness (107)
Blood Pressure Decreased (105)
C-reactive Protein Increased (105)
Renal Failure Acute (103)
Haemoglobin Decreased (85)
Anaemia (84)
Blood Lactate Dehydrogenase Increased (84)
Underdose (83)
Abdominal Pain Upper (81)

➢ 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.

Voltaren Side Effects Reported to FDA



Voltaren Side Effect Report#9998252
Hypotension, Abasia, Eye Disorder, Haemorrhage, Fall, Joint Injury
This is a report of a 76-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Voltaren Gel (dosage: Unk, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Hypotension, Abasia, Eye Disorder, Haemorrhage, Fall, Joint Injury after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Voltaren Gel treatment in male patients, resulting in Hypotension side effect. The patient was hospitalized.
Voltaren Side Effect Report#9993466
Hepatic Enzyme Increased, Transaminases Increased, Liver Disorder, Sciatica, Sleep Disorder
This report suggests a potential Voltaren Resinat 20 Kap Hepatic Enzyme Increased side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: back pain and used Voltaren Resinat 20 Kap (dosage: 1 Df, Qd) starting
Nov 15, 2013. After starting Voltaren Resinat 20 Kap the patient began experiencing various side effects, including: Hepatic Enzyme Increased, Transaminases Increased, Liver Disorder, Sciatica, Sleep DisorderAdditional drugs used concurrently:
  • Katadolon (1 Df, Qd)
  • Novaminsulfon (2 Df, Qd)
  • Tramundin (2 Df, Qd)
The patient was hospitalized. Although Voltaren Resinat 20 Kap demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Enzyme Increased, may still occur.
Voltaren Side Effect Report#9993181
Pulmonary Embolism, Arthritis
This Pulmonary Embolism problem was reported by a consumer or non-health professional from US. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Voltaren Gel (dosage: 2 G, Bid). The following drugs were being taken at the same time: NA. When using Voltaren Gel, the patient experienced the following unwanted symptoms/side effects: Pulmonary Embolism, ArthritisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Embolism, may become evident only after a product is in use by the general population.
Voltaren Side Effect Report#9975835
Thrombosis, Dyspnoea, Pain
This Thrombosis side effect was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoarthritis,underdose,off label use.The patient was prescribed Voltaren Gel (drug dosage: 1 G, Qd), which was initiated on 2011. Concurrently used drugs: NA..After starting to take Voltaren Gel the consumer reported adverse symptoms, such as: Thrombosis, Dyspnoea, PainThese side effects may potentially be related to Voltaren Gel.
Voltaren Side Effect Report#9975818
Disability, Therapeutic Response Unexpected
This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: fat tissue increased,off label use, who was treated with Voltaren Gel (dosage: 1/5 Of A Dosage Of Toothpaste, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Disability, Therapeutic Response Unexpected after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Voltaren Gel treatment in male patients, resulting in Disability side effect.
Voltaren Side Effect Report#9964938
Gastritis
This report suggests a potential Voltaren Gastritis side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: back pain and used Voltaren (dosage: Unk Ukn, Unk) starting
Dec 19, 2013. After starting Voltaren the patient began experiencing various side effects, including: GastritisAdditional drugs used concurrently:
  • Tramadol (Unk Ukn, Unk)
  • Proton Pump Inhibitors (Unk Ukn, Unk)
Although Voltaren demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastritis, may still occur.
Voltaren Side Effect Report#9964186
Haemorrhage Intracranial
This Haemorrhage Intracranial problem was reported by a health professional from FR. A 92-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Voltarene (dosage: Unk Ukn, Unk). The following drugs were being taken at the same time:
  • Amiodarone (100 Mg, Qd)
  • Pradaxa (110 Mg, Bid)
  • Spironolactone (Unk Ukn, Unk)
  • Spasfon (Unk Ukn, Unk)
  • Doliprane (Unk Ukn, Unk)
  • Macrogol (Unk Ukn, Unk)
When using Voltarene, the patient experienced the following unwanted symptoms/side effects: Haemorrhage IntracranialAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhage Intracranial, may become evident only after a product is in use by the general population.
Voltaren Side Effect Report#9956362
Breast Cancer, Underdose
This Breast Cancer side effect was reported by a consumer or non-health professional from US. A 75-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Voltaren Gel (drug dosage: Unk, 3 Or 4 X A Day), which was initiated on 2011. Concurrently used drugs: NA..After starting to take Voltaren Gel the consumer reported adverse symptoms, such as: Breast Cancer, UnderdoseThese side effects may potentially be related to Voltaren Gel.
Voltaren Side Effect Report#9954375
Gastritis
This is a report of a 62-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Voltaren (dosage: 3 Df, Qd, start time:
Feb 05, 2014), combined with:
  • Triatec (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Gastritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Voltaren treatment in female patients, resulting in Gastritis side effect. The patient was hospitalized.
Voltaren Side Effect Report#9943446
Condition Aggravated, Gastric Ulcer Helicobacter, Anaemia
This report suggests a potential Voltarene Condition Aggravated side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Voltarene (dosage: 1 Df, Daily) starting
Jan 24, 2013. After starting Voltarene the patient began experiencing various side effects, including: Condition Aggravated, Gastric Ulcer Helicobacter, AnaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Voltarene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Condition Aggravated, may still occur.
Voltaren Side Effect Report#9943232
Intervertebral Disc Protrusion, Arthralgia, Musculoskeletal Discomfort
This Intervertebral Disc Protrusion problem was reported by a consumer or non-health professional from US. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: carpal tunnel syndrome,off label use. On NS this consumer started treatment with Voltaren Gel (dosage: 4 G, Prn). The following drugs were being taken at the same time: NA. When using Voltaren Gel, the patient experienced the following unwanted symptoms/side effects: Intervertebral Disc Protrusion, Arthralgia, Musculoskeletal DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Intervertebral Disc Protrusion, may become evident only after a product is in use by the general population.
Voltaren Side Effect Report#9935590
Wrist Fracture, Contusion, Inflammation, Underdose, Incorrect Dose Administered
This Wrist Fracture side effect was reported by a consumer or non-health professional from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis,pain,off label use.The patient was prescribed Voltaren Gel (drug dosage: Enough To Cover, 3-4x/day), which was initiated on 2009. Concurrently used drugs: NA..After starting to take Voltaren Gel the consumer reported adverse symptoms, such as: Wrist Fracture, Contusion, Inflammation, Underdose, Incorrect Dose AdministeredThese side effects may potentially be related to Voltaren Gel.
Voltaren Side Effect Report#9934626
Corneal Perforation, Visual Acuity Reduced, Corneal Lesion, Feeling Abnormal
This is a report of a 71-year-old female patient (weight: NA) from ZA, suffering from the following health symptoms/conditions: eye pain, who was treated with Voltaren (dosage: Unk Ukn, Unk, start time: 201210), combined with:
  • Antibiotics
  • Tears Naturale
and developed a serious reaction and side effect(s): Corneal Perforation, Visual Acuity Reduced, Corneal Lesion, Feeling Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Voltaren treatment in female patients, resulting in Corneal Perforation side effect. The patient was hospitalized.
Voltaren Side Effect Report#9931134
Visual Impairment
This report suggests a potential Voltaren Visual Impairment side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from NO was diagnosed with the following symptoms/conditions: osteoarthritis and used Voltaren (dosage: 50 Mg, Qd) starting 2004. After starting Voltaren the patient began experiencing various side effects, including: Visual ImpairmentAdditional drugs used concurrently: NA. Although Voltaren demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Visual Impairment, may still occur.
Voltaren Side Effect Report#9926069
Salmonellosis, Gastric Disorder, Gastrointestinal Motility Disorder, Back Pain, Chest Pain, Gastrointestinal Ulcer, Asthenia
This Salmonellosis problem was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: neuralgia,off label use. On NS this consumer started treatment with Voltaren Gel (dosage: Recommended Amount, Unk). The following drugs were being taken at the same time: NA. When using Voltaren Gel, the patient experienced the following unwanted symptoms/side effects: Salmonellosis, Gastric Disorder, Gastrointestinal Motility Disorder, Back Pain, Chest Pain, Gastrointestinal Ulcer, AstheniaThe 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 Salmonellosis, may become evident only after a product is in use by the general population.
Voltaren Side Effect Report#9922439
Dementia, Cerebrovascular Accident
This Dementia side effect was reported by a consumer or non-health professional from US. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: back pain,off label use.The patient was prescribed Voltaren Gel (drug dosage: Unk, Prn), which was initiated on NS. Concurrently used drugs: NA..After starting to take Voltaren Gel the consumer reported adverse symptoms, such as: Dementia, Cerebrovascular AccidentThese side effects may potentially be related to Voltaren Gel.
Voltaren Side Effect Report#9920293
Hypovolaemic Shock, Shock Haemorrhagic, Hypotension, Haemorrhagic Anaemia, Gastric Ulcer, Haematemesis, Melaena, Perforated Ulcer, Gastrointestinal Haemorrhage
This is a report of a 91-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: back pain, who was treated with Voltarene Lp (dosage: 75 Mg, Qd, start time:
Oct 15, 2013), combined with:
  • Coversyl (10 Mg, Unk)
  • Levothyrox (25 Ug, Unk)
  • Lasilix (40 Mg, Unk)
  • Spironolactone (Unk Ukn, Unk)
  • Pantoprazole (20 Mg, Unk)
  • Alprazolam (Unk Ukn, Unk)
  • Durogesic (50 Ug/hr, Unk)
and developed a serious reaction and side effect(s): Hypovolaemic Shock, Shock Haemorrhagic, Hypotension, Haemorrhagic Anaemia, Gastric Ulcer, Haematemesis, Melaena, Perforated Ulcer, Gastrointestinal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Voltarene Lp treatment in female patients, resulting in Hypovolaemic Shock side effect.
Voltaren Side Effect Report#9920203
Intervertebral Disc Disorder, Back Pain, Arthritis, Back Injury, Therapeutic Response Unexpected
This report suggests a potential Voltaren Gel Intervertebral Disc Disorder side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis,pain,off label use and used Voltaren Gel (dosage: Sparingly, Prn) starting 2010. After starting Voltaren Gel the patient began experiencing various side effects, including: Intervertebral Disc Disorder, Back Pain, Arthritis, Back Injury, Therapeutic Response UnexpectedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Voltaren Gel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intervertebral Disc Disorder, may still occur.
Voltaren Side Effect Report#9920039
Subcutaneous Abscess
This Subcutaneous Abscess problem was reported by a consumer or non-health professional from PT. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: renal colic. On
Jun 22, 2013 this consumer started treatment with Voltaren (dosage: Unk Ukn, Unk). The following drugs were being taken at the same time: NA. When using Voltaren, the patient experienced the following unwanted symptoms/side effects: Subcutaneous AbscessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Subcutaneous Abscess, may become evident only after a product is in use by the general population.
Voltaren Side Effect Report#9919839
Feeling Hot, Diarrhoea, Erythema, Pruritus
This Feeling Hot side effect was reported by a health professional from IT. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Voltaren (drug dosage: Unk Ukn, Unk), which was initiated on
Jan 01, 2012. Concurrently used drugs:
  • Atenolol (50 Mg, Unk)
  • Zanedip (Unk Ukn, Unk)
  • Tiklid (Unk Ukn, Unk)
  • Vasoretic (Unk Ukn, Unk)
  • Dibase (Unk Ukn, Unk)
  • Delorazepam (Unk Ukn, Unk)
  • Eskim (Unk Ukn, Unk)
.After starting to take Voltaren the consumer reported adverse symptoms, such as: Feeling Hot, Diarrhoea, Erythema, PruritusThese side effects may potentially be related to Voltaren. The patient was hospitalized.
Voltaren Side Effect Report#9911717
Fall, Hip Fracture, Arthralgia, Gait Disturbance, Arthropathy, Underdose
This is a report of a 86-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis,pain, who was treated with Voltaren Gel (dosage: A Little Bubble, Tid, start time: 2013), combined with:
  • Celebrex
and developed a serious reaction and side effect(s): Fall, Hip Fracture, Arthralgia, Gait Disturbance, Arthropathy, Underdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Voltaren Gel treatment in female patients, resulting in Fall side effect. The patient was hospitalized.
Voltaren Side Effect Report#9911542
Swelling Face, Eye Swelling, Blood Pressure Increased
This report suggests a potential Voltaren Swelling Face side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from GR was diagnosed with the following symptoms/conditions: NA and used Voltaren (dosage: Unk Ukn, Unk) starting NS. After starting Voltaren the patient began experiencing various side effects, including: Swelling Face, Eye Swelling, Blood Pressure IncreasedAdditional drugs used concurrently:
  • Depon (Unk Ukn, Unk)
Although Voltaren demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Swelling Face, may still occur.
Voltaren Side Effect Report#9911482
Ear Haemorrhage, Application Site Pain, Epistaxis
This Ear Haemorrhage problem was reported by a consumer or non-health professional from US. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: scab,off label use. On
Feb 01, 2014 this consumer started treatment with Voltaren Gel (dosage: A Little Bit, Unk). The following drugs were being taken at the same time: NA. When using Voltaren Gel, the patient experienced the following unwanted symptoms/side effects: Ear Haemorrhage, Application Site Pain, EpistaxisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ear Haemorrhage, may become evident only after a product is in use by the general population.
Voltaren Side Effect Report#9902846
Corneal Perforation, Eye Infection, Blister, Feeling Abnormal, Depressed Mood, Acanthamoeba Keratitis, Eye Irritation, Eye Pain
This Corneal Perforation side effect was reported by a consumer or non-health professional from ZA. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: eye pain.The patient was prescribed Voltaren Ophtha (drug dosage: Unk Ukn, Unk), which was initiated on 2012. Concurrently used drugs: NA..After starting to take Voltaren Ophtha the consumer reported adverse symptoms, such as: Corneal Perforation, Eye Infection, Blister, Feeling Abnormal, Depressed Mood, Acanthamoeba Keratitis, Eye Irritation, Eye PainThese side effects may potentially be related to Voltaren Ophtha. The patient was hospitalized and became disabled.
Voltaren Side Effect Report#9902785
Pancreatic Carcinoma, Metastasis
This is a report of a 59-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: pain, who was treated with Voltaren (dosage: Unk Ukn, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pancreatic Carcinoma, Metastasis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Voltaren treatment in female patients, resulting in Pancreatic Carcinoma side effect.


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The appearance of Voltaren 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.

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.

    Voltaren 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.

    Discuss Voltaren Side Effects

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    How Effective is Voltaren for You?

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    Voltaren Safety Alerts, Active Ingredients, Usage Information

    NDC0078-0446
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameVoltaren XR
    Namediclofenac sodium extended release tablets
    Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
    RouteORAL
    On market since19960308
    LabelerNovartis Pharmaceuticals Corporation
    Active Ingredient(s)DICLOFENAC SODIUM
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammato

    Voltaren Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2990

    Voltaren safety alerts: 2009

    Reported deaths: 260

    Reported hospitalizations: 1276

    Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

    Audience: Rheumatological healthcare professionals, pharmacists

    [Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium. 

    In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of  these reported cases resulted in fatalities or liver transplantation. 

    Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

    [12/04/2009 - Dear Healthcare Professional Letter - Endo, Novartis]
    [Sept 2009 - Prescribing Information - Endo]

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