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Diclofenac Sodium Side Effects

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Common Diclofenac Sodium Side Effects


The most commonly reported Diclofenac Sodium side effects are:
Mood Swings (2)
Noise Breathing (1)
Cholesterol (1)
Menstrual Cycle (1)

If you have experienced a side effect listed above, you can check a box to report it.


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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.

Diclofenac Sodium Side Effects Reported to FDA



Diclofenac Sodium Side Effect Report#9994768
Pain, Pyrexia, Gait Disturbance, Injection Site Abscess, Clostridial Infection, Toxicity To Various Agents, Wound
This is a report of a 19-year-old male patient (weight: NA) from IN, suffering from the following health symptoms/conditions: pyrexia,pain, who was treated with Diclofenac Sodium (dosage: NA, start time: 200809), combined with: NA. and developed a serious reaction and side effect(s): Pain, Pyrexia, Gait Disturbance, Injection Site Abscess, Clostridial Infection, Toxicity To Various Agents, Wound after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium treatment in male patients, resulting in Pain side effect. The patient was hospitalized.
Diclofenac Sodium Side Effect Report#9970849
Tinnitus
This report suggests a potential Diclofenac Sodium Tinnitus side effect(s) that can have serious consequences. A 48-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: spondylitis and used Diclofenac Sodium (dosage: 1 Tablet) starting
Feb 01, 2014. After starting Diclofenac Sodium the patient began experiencing various side effects, including: TinnitusAdditional drugs used concurrently: NA. Although Diclofenac Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tinnitus, may still occur.
Diclofenac Sodium Side Effect Report#9917208
Choking, Product Quality Issue
This Choking problem was reported by a consumer or non-health professional from US. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On 201312 this consumer started treatment with Diclofenac Sodium/misoprostol (dosage: 200/75 Mcg/mg, 2x/day). The following drugs were being taken at the same time: NA. When using Diclofenac Sodium/misoprostol, the patient experienced the following unwanted symptoms/side effects: Choking, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Choking, may become evident only after a product is in use by the general population.
Diclofenac Sodium Side Effect Report#9913681
Renal Failure Chronic
This Renal Failure Chronic side effect was reported by a health professional from US. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Diclofenac Sodium Delayed Release (drug dosage: NA), which was initiated on 2010. Concurrently used drugs: NA..After starting to take Diclofenac Sodium Delayed Release the consumer reported adverse symptoms, such as: Renal Failure ChronicThese side effects may potentially be related to Diclofenac Sodium Delayed Release.
Diclofenac Sodium Side Effect Report#9888639
Poisoning, Exposure Via Ingestion, Completed Suicide
This is a report of a 50-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Diclofenac Sodium Extended-release (dosage: NA, start time: NS), combined with:
  • Conjugated Estrogens
  • Citalopram
  • Tramadol
  • Procet
  • Lisinopril
  • Pregabalin
and developed a serious reaction and side effect(s): Poisoning, Exposure Via Ingestion, Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium Extended-release treatment in patients, resulting in Poisoning side effect.
Diclofenac Sodium Side Effect Report#9845156
Hyperkalaemia, Renal Failure Acute
This report suggests a potential Diclofenac Sodium Hyperkalaemia side effect(s) that can have serious consequences. A 91-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: back pain,hypertension and used Diclofenac Sodium (dosage: NA) starting
Jan 01, 2012. After starting Diclofenac Sodium the patient began experiencing various side effects, including: Hyperkalaemia, Renal Failure AcuteAdditional drugs used concurrently:
  • Losazid (1 Df Daily)
  • Lasix (25 Mg)
  • Cardioaspirin (100 Mg)
  • Ferro Grad C (1 Df)
  • Pantoprazole Sodium (1 Df)
  • Nitroglycerin (5 Mg)
  • Bisoprolol Hemifumarate (2.5 Mg)
  • Atorvastatin Calcium Trihydrate (20 Mg)
The patient was hospitalized. Although Diclofenac Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperkalaemia, may still occur.
Diclofenac Sodium Side Effect Report#9834353
Hyperkalaemia, Renal Failure Acute
This Hyperkalaemia problem was reported by a pharmacist from IT. A 91-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain,hypertension. On
Jan 01, 2012 this consumer started treatment with Diclofenac Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Losazid - Sigma-tau Industrie Farmaceutiche Riunite Spa (1 Dosage Forms Daily;)
  • Lasix - 25 Mg Compresse (25 Milligram Daily;)
  • Cardioaspirin - 100 Mg Compresse Gastroresistenti (100 Milligram Daily;)
  • Ferro Grad C - 105 Mg + 500 Mg Compresse A Rilascio Prolungato (1 Dosage Forms Daily;)
  • Pantoprazole Sodium (1 Dosage Forms Daily;)
  • Nitroglycerin (5 Milligram Daily;)
  • Bisoprolol Hemifumarate (2.5 Milligram Daily;)
  • Atorvastatin Calcium Trihydrate (20 Milligram Daily;)
When using Diclofenac Sodium, the patient experienced the following unwanted symptoms/side effects: Hyperkalaemia, Renal Failure AcuteThe 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 Hyperkalaemia, may become evident only after a product is in use by the general population.
Diclofenac Sodium Side Effect Report#9799378
Ileal Perforation
This Ileal Perforation side effect was reported by a health professional from KR. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: procedural pain.The patient was prescribed Diclofenac Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Diclofenac Sodium the consumer reported adverse symptoms, such as: Ileal PerforationThese side effects may potentially be related to Diclofenac Sodium. The patient was hospitalized.
Diclofenac Sodium Side Effect Report#9799091
Ileal Perforation
This is a report of a 69-year-old female patient (weight: NA) from KR, suffering from the following health symptoms/conditions: postoperative care, who was treated with Diclofenac Sodium (dosage: 2 In 1 D, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Ileal Perforation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium treatment in female patients, resulting in Ileal Perforation side effect. The patient was hospitalized.
Diclofenac Sodium Side Effect Report#9775658
Wheezing, Dyspnoea
This report suggests a potential Diclofenac Sodium Wheezing side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Diclofenac Sodium (dosage: Unk) starting
Nov 26, 2013. After starting Diclofenac Sodium the patient began experiencing various side effects, including: Wheezing, DyspnoeaAdditional drugs used concurrently:
  • Naproxen (Unk)
  • Cetirizine (Unk)
  • Oramorph (Unk)
  • Paracetamol (Unk)
  • Tramadol (Unk)
  • Lansoprazole (Unk)
Although Diclofenac Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Wheezing, may still occur.
Diclofenac Sodium Side Effect Report#9651079
Hypersensitivity
This Hypersensitivity problem was reported by a pharmacist from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 01, 2013 this consumer started treatment with Diclofenac Sodium/misoprostol (dosage: 75mg Two Times A Day). The following drugs were being taken at the same time: NA. When using Diclofenac Sodium/misoprostol, the patient experienced the following unwanted symptoms/side effects: HypersensitivityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Diclofenac Sodium Side Effect Report#9647647
Nausea, Malaise, Product Physical Issue
This Nausea side effect was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: systemic lupus erythematosus.The patient was prescribed Diclofenac Sodium/misoprostol (drug dosage: 75-0.2 Twice Daily Taken By Mouth), which was initiated on
Oct 24, 2013. Concurrently used drugs: NA..After starting to take Diclofenac Sodium/misoprostol the consumer reported adverse symptoms, such as: Nausea, Malaise, Product Physical IssueThese side effects may potentially be related to Diclofenac Sodium/misoprostol.
Diclofenac Sodium Side Effect Report#9580212
Gas Gangrene, Iatrogenic Infection, Clostridial Infection, Gait Disturbance
This is a report of a 19-year-old male patient (weight: NA) from IN, suffering from the following health symptoms/conditions: NA, who was treated with Diclofenac Sodium (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Gas Gangrene, Iatrogenic Infection, Clostridial Infection, Gait Disturbance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium treatment in male patients, resulting in Gas Gangrene side effect. The patient was hospitalized.
Diclofenac Sodium Side Effect Report#9559890
Kounis Syndrome, Anaphylactic Reaction
This report suggests a potential Diclofenac Sodium Kounis Syndrome side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: NA and used Diclofenac Sodium (dosage: 50 Mg, Once, Intamuscular In Gluteal Region) starting NS. After starting Diclofenac Sodium the patient began experiencing various side effects, including: Kounis Syndrome, Anaphylactic ReactionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Diclofenac Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Kounis Syndrome, may still occur.
Diclofenac Sodium Side Effect Report#9498235
Jaw Fracture, Grand Mal Convulsion
This Jaw Fracture problem was reported by a physician from GB. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diclofenac Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Folic Acid
  • Mabthera
  • Methotrexate
When using Diclofenac Sodium, the patient experienced the following unwanted symptoms/side effects: Jaw Fracture, Grand Mal ConvulsionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Jaw Fracture, may become evident only after a product is in use by the general population.
Diclofenac Sodium Side Effect Report#9471779
Grand Mal Convulsion, Initial Insomnia
This Grand Mal Convulsion side effect was reported by a consumer or non-health professional from GB. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: procedural pain.The patient was prescribed Diclofenac Sodium (drug dosage: NA), which was initiated on
Mar 18, 2013. Concurrently used drugs:
  • Lamictal
.After starting to take Diclofenac Sodium the consumer reported adverse symptoms, such as: Grand Mal Convulsion, Initial InsomniaThese side effects may potentially be related to Diclofenac Sodium.
Diclofenac Sodium Side Effect Report#9361370
Suicidal Ideation, Off Label Use
This is a report of a 26-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: pain,hypermobility syndrome,osteoarthritis,osteoporosis,myalgia,rheumatoid arthritis, who was treated with Diclofenac Sodium (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Suicidal Ideation, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium treatment in female patients, resulting in Suicidal Ideation side effect.
Diclofenac Sodium Side Effect Report#9360099
Suicide Attempt, Lactic Acidosis, Toxicity To Various Agents
This report suggests a potential Diclofenac Sodium Suicide Attempt side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from TR was diagnosed with the following symptoms/conditions: NA and used Diclofenac Sodium (dosage: Took Many Pills) starting NS. After starting Diclofenac Sodium the patient began experiencing various side effects, including: Suicide Attempt, Lactic Acidosis, Toxicity To Various AgentsAdditional drugs used concurrently:
  • Metformin Hydrochloride (Took 28 Gram)
The patient was hospitalized. Although Diclofenac Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicide Attempt, may still occur.
Diclofenac Sodium Side Effect Report#9355457
Bronchospasm, Hypoventilation
This Bronchospasm problem was reported by a health professional from GB. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: procedural site reaction. On
May 31, 2013 this consumer started treatment with Diclofenac Sodium (dosage: 75 Mg, Unk). The following drugs were being taken at the same time:
  • Bendroflumethiazide (Unk)
  • Paracetamol (Unk)
  • Amlodipine (Unk)
When using Diclofenac Sodium, the patient experienced the following unwanted symptoms/side effects: Bronchospasm, HypoventilationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bronchospasm, may become evident only after a product is in use by the general population.
Diclofenac Sodium Side Effect Report#9353112
Atrial Fibrillation
This Atrial Fibrillation side effect was reported by a consumer or non-health professional from US. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: joint swelling.The patient was prescribed Diclofenac Sodium Delayed-release (drug dosage: 1 Pill 7 Pm On 5-10-13.), which was initiated on
May 10, 2013. Concurrently used drugs: NA..After starting to take Diclofenac Sodium Delayed-release the consumer reported adverse symptoms, such as: Atrial FibrillationThese side effects may potentially be related to Diclofenac Sodium Delayed-release. The patient was hospitalized.
Diclofenac Sodium Side Effect Report#9339525
Atrial Fibrillation
This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthralgia, who was treated with Diclofenac Sodium (dosage: 1 Dose, start time:
May 10, 2013), combined with: NA. and developed a serious reaction and side effect(s): Atrial Fibrillation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium treatment in female patients, resulting in Atrial Fibrillation side effect. The patient was hospitalized.
Diclofenac Sodium Side Effect Report#9314462
Malaise, Nausea, Lethargy, Irritability, Abdominal Pain, Pain
This report suggests a potential Diclofenac Sodium/misoprostol Malaise side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Diclofenac Sodium/misoprostol (dosage: 1 Tablet Twice A Day) starting NS. After starting Diclofenac Sodium/misoprostol the patient began experiencing various side effects, including: Malaise, Nausea, Lethargy, Irritability, Abdominal Pain, PainAdditional drugs used concurrently: NA. Although Diclofenac Sodium/misoprostol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Diclofenac Sodium Side Effect Report#9248268
Gastrointestinal Disorder, Electrocardiogram Abnormal, Dyspnoea, Blood Pressure Decreased, Chest Pain, Decreased Appetite, Dizziness, Anxiety, Insomnia
This Gastrointestinal Disorder problem was reported by a consumer or non-health professional from Country Not Specified. A 28-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diclofenac Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Valoid /00014903/
  • Baclofen
  • Enoxaparin
  • Ondansetron
When using Diclofenac Sodium, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Disorder, Electrocardiogram Abnormal, Dyspnoea, Blood Pressure Decreased, Chest Pain, Decreased Appetite, Dizziness, Anxiety, InsomniaThe 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 Gastrointestinal Disorder, may become evident only after a product is in use by the general population.
Diclofenac Sodium Side Effect Report#9248150
No Adverse Event
This No Adverse Event side effect was reported by a consumer or non-health professional from Country Not Specified. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diclofenac Sodium (drug dosage: NA), which was initiated on
Jan 09, 2013. Concurrently used drugs:
  • Finasteride
  • Omeprazole
  • Prochlorperazine
  • Dutasteride
.After starting to take Diclofenac Sodium the consumer reported adverse symptoms, such as: No Adverse EventThese side effects may potentially be related to Diclofenac Sodium.
Diclofenac Sodium Side Effect Report#9219061
Toxic Epidermal Necrolysis
This is a report of a 73-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Diclofenac Sodium (dosage: NA, start time:
Feb 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Toxic Epidermal Necrolysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium treatment in female patients, resulting in Toxic Epidermal Necrolysis side effect.


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The appearance of Diclofenac Sodium 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 Diclofenac Sodium Side Effects for Women?

Women Side EffectsReports
Abdominal Pain 51
Diarrhoea 50
Haemoglobin Decreased 43
Vomiting 43
Nausea 38
Anaemia 30
Gastrointestinal Disorder 29
Renal Failure Acute 29
Gastrointestinal Haemorrhage 28
Abdominal Pain Upper 27

What are common Diclofenac Sodium Side Effects for Men?

Men Side EffectsReports
Renal Failure Acute 50
Vomiting 41
Gastrointestinal Haemorrhage 35
Blood Creatinine Increased 30
Blood Urea Increased 30
Dyspnoea 29
Malaise 29
Haemoglobin Decreased 26
Diarrhoea 25
Dehydration 24

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  • 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.

    Diclofenac Sodium 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 Diclofenac Sodium for You?

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    Diclofenac Sodium Safety Alerts, Active Ingredients, Usage Information

    NDC0093-1041
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDiclofenac Sodium
    NameDiclofenac Sodium
    Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
    RouteORAL
    On market since20000228
    LabelerTEVA Pharmaceuticals USA Inc.
    Active Ingredient(s)DICLOFENAC SODIUM
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammato

    More About Diclofenac sodium

    Side Effects reported to FDA: 1584

    Diclofenac Sodium safety alerts: 2009

    Reported deaths: 158

    Reported hospitalizations: 874

    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]

    Latest Diclofenac Sodium clinical trials