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Diclofenac Side Effects

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Common Diclofenac Side Effects


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

Renal Failure Acute (154)
Abdominal Pain (139)
Diarrhoea (136)
Vomiting (127)
Dyspnoea (103)
Haemoglobin Decreased (103)
Gastrointestinal Haemorrhage (102)
Nausea (88)
Blood Creatinine Increased (88)
Anaemia (86)
Malaise (83)
Dehydration (82)
Pruritus (79)
Abdominal Pain Upper (77)
Blood Urea Increased (76)
Dizziness (72)
Gastric Ulcer (68)
Gastrointestinal Disorder (68)
Haematemesis (64)
Anaphylactic Reaction (62)

➢ 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.

Diclofenac Side Effects Reported to FDA



Diclofenac Side Effect Report#9999544
Urticaria, Pruritus
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Diclofenac (dosage: NA, start time:
Sep 26, 2013), combined with: NA. and developed a serious reaction and side effect(s): Urticaria, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac treatment in male patients, resulting in Urticaria side effect.
Diclofenac Side Effect Report#9994768
Pain, Pyrexia, Gait Disturbance, Injection Site Abscess, Clostridial Infection, Toxicity To Various Agents, Wound
This report suggests a potential Diclofenac Sodium Pain side effect(s) that can have serious consequences. A 19-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: pyrexia,pain and used Diclofenac Sodium (dosage: NA) starting 200809. After starting Diclofenac Sodium the patient began experiencing various side effects, including: Pain, Pyrexia, Gait Disturbance, Injection Site Abscess, Clostridial Infection, Toxicity To Various Agents, WoundAdditional 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 Pain, may still occur.
Diclofenac Side Effect Report#9988771
Pregnancy, Exposure During Pregnancy
This Pregnancy problem was reported by a consumer or non-health professional from BG. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diclofenac Duo ^pharmavit^ (dosage: NA). The following drugs were being taken at the same time: NA. When using Diclofenac Duo ^pharmavit^, the patient experienced the following unwanted symptoms/side effects: Pregnancy, Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pregnancy, may become evident only after a product is in use by the general population.
Diclofenac Side Effect Report#9971230
Cardiac Failure Acute, Pulmonary Oedema, Cardiac Arrest, Bradycardia, Neurological Symptom, Coagulopathy, Angiopathy, Premature Delivery
This Cardiac Failure Acute side effect was reported by a health professional from PL. A 20-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diclofenac (drug dosage: Unk), which was initiated on
Nov 27, 2006. Concurrently used drugs:
  • Paracetamol (Unk)
  • Haloperidol
  • Furosemide
  • Solu-medrol
  • Dolcontral
  • Losec /can/
  • Zofran
  • Mannitol
.After starting to take Diclofenac the consumer reported adverse symptoms, such as: Cardiac Failure Acute, Pulmonary Oedema, Cardiac Arrest, Bradycardia, Neurological Symptom, Coagulopathy, Angiopathy, Premature DeliveryThese side effects may potentially be related to Diclofenac.
Diclofenac Side Effect Report#9970849
Tinnitus
This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: spondylitis, who was treated with Diclofenac Sodium (dosage: 1 Tablet, start time:
Feb 01, 2014), combined with: NA. and developed a serious reaction and side effect(s): Tinnitus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium treatment in female patients, resulting in Tinnitus side effect.
Diclofenac Side Effect Report#9970205
Hypochondriasis, Depression
This report suggests a potential Diclofenac Hypochondriasis side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from DK was diagnosed with the following symptoms/conditions: arthralgia and used Diclofenac (dosage: NA) starting
Oct 05, 2013. After starting Diclofenac the patient began experiencing various side effects, including: Hypochondriasis, DepressionAdditional drugs used concurrently: NA. Although Diclofenac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypochondriasis, may still occur.
Diclofenac Side Effect Report#9964033
Cluster Headache, Facial Pain, Headache, Eye Pain, Rhinorrhoea, Lacrimation Increased, Conjunctival Hyperaemia, Eyelid Ptosis
This Cluster Headache problem was reported by a health professional from IT. A 24-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diclofenac (dosage: NA). The following drugs were being taken at the same time:
  • Ketorolac
  • Ibuprofen
  • Tramadol
  • Paracetamol (1000 Mg, Per Day)
  • Dexamethasone (8 Mg, Per Day)
  • Prednisone (50 Mg, Day)
  • Sumatriptan (6 Mg, Unk)
  • Cocaine
When using Diclofenac, the patient experienced the following unwanted symptoms/side effects: Cluster Headache, Facial Pain, Headache, Eye Pain, Rhinorrhoea, Lacrimation Increased, Conjunctival Hyperaemia, Eyelid PtosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cluster Headache, may become evident only after a product is in use by the general population.
Diclofenac Side Effect Report#9934074
Renal Impairment
This Renal Impairment side effect was reported by a health professional from JP. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diclofenac (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Loxoprofen (180 Mg, Day)
  • Prednisolone (10 Mg, Day)
  • Levofloxacin
  • Fluorometholone
.After starting to take Diclofenac the consumer reported adverse symptoms, such as: Renal ImpairmentThese side effects may potentially be related to Diclofenac.
Diclofenac Side Effect Report#9929684
Delusion, Depression, Hypochondriasis
This is a report of a 62-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: arthralgia, who was treated with Diclofenac (dosage: Daily Dose: 150 Mg Millgram(s) Every Days, start time:
Oct 05, 2013), combined with: NA. and developed a serious reaction and side effect(s): Delusion, Depression, Hypochondriasis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac treatment in male patients, resulting in Delusion side effect. The patient was hospitalized.
Diclofenac Side Effect Report#9926080
Delusion, Depression, Hypochondriasis
This report suggests a potential Diclofenac Delusion side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: arthralgia and used Diclofenac (dosage: 150 Milligram Daily;) starting
Oct 05, 2013. After starting Diclofenac the patient began experiencing various side effects, including: Delusion, Depression, HypochondriasisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Diclofenac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Delusion, may still occur.
Diclofenac 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 Side Effect Report#9914680
Gastric Disorder, Hiatus Hernia, Gastric Ulcer, Abdominal Pain Upper, Dyspepsia, Nausea, Decreased Appetite
This Gastric Disorder side effect was reported by a health professional from IT. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: musculoskeletal pain.The patient was prescribed Diclofenac (drug dosage: 1 Df, Qd), which was initiated on
Nov 16, 2013. Concurrently used drugs:
  • Targin (1 Df, Qd)
.After starting to take Diclofenac the consumer reported adverse symptoms, such as: Gastric Disorder, Hiatus Hernia, Gastric Ulcer, Abdominal Pain Upper, Dyspepsia, Nausea, Decreased AppetiteThese side effects may potentially be related to Diclofenac. The patient was hospitalized.
Diclofenac Side Effect Report#9913681
Renal Failure Chronic
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis, who was treated with Diclofenac Sodium Delayed Release (dosage: NA, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Chronic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac Sodium Delayed Release treatment in female patients, resulting in Renal Failure Chronic side effect.
Diclofenac Side Effect Report#9906948
Cardiac Arrest, Cardiac Failure Acute, Coronary Artery Thrombosis, Chest Pain, Fatigue, Dyspnoea
This report suggests a potential Diclofenac Rapid Actavis Cardiac Arrest side effect(s) that can have serious consequences. A 56-year-old male patient (weight: NA) from DK was diagnosed with the following symptoms/conditions: gout and used Diclofenac Rapid Actavis (dosage: Unk. Styrke: 50 Mg.) starting NS. After starting Diclofenac Rapid Actavis the patient began experiencing various side effects, including: Cardiac Arrest, Cardiac Failure Acute, Coronary Artery Thrombosis, Chest Pain, Fatigue, DyspnoeaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Diclofenac Rapid Actavis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Diclofenac Side Effect Report#9905422
Acute Myocardial Infarction, Blood Pressure Decreased
This Acute Myocardial Infarction problem was reported by a physician from IL. A 51-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On NS this consumer started treatment with Diclofenac (diclofenac) (dosage: NA). The following drugs were being taken at the same time: NA. When using Diclofenac (diclofenac), the patient experienced the following unwanted symptoms/side effects: Acute Myocardial Infarction, Blood Pressure DecreasedThe 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 Acute Myocardial Infarction, may become evident only after a product is in use by the general population.
Diclofenac Side Effect Report#9902971
Colitis Microscopic, Diarrhoea
This Colitis Microscopic side effect was reported by a health professional from JP. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Diclofenac (drug dosage: NA), which was initiated on 200809. Concurrently used drugs:
  • Takepron (15 Mg, Daily)
.After starting to take Diclofenac the consumer reported adverse symptoms, such as: Colitis Microscopic, DiarrhoeaThese side effects may potentially be related to Diclofenac.
Diclofenac Side Effect Report#9899546
Hypersensitivity, Joint Swelling, Swelling Face
This is a report of a 47-year-old female patient (weight: NA) from NO, suffering from the following health symptoms/conditions: NA, who was treated with Diclofenac (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hypersensitivity, Joint Swelling, Swelling Face after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac treatment in female patients, resulting in Hypersensitivity side effect.
Diclofenac Side Effect Report#9892207
Rocky Mountain Spotted Fever, Pyrexia, Nausea, Bacteraemia, Petechiae, Cyanosis, Pulse Abnormal, Abdominal Tenderness, Dehydration
This report suggests a potential Diclofenac Rocky Mountain Spotted Fever side effect(s) that can have serious consequences. A 5-year-old female patient (weight: NA) from PA was diagnosed with the following symptoms/conditions: NA and used Diclofenac (dosage: NA) starting NS. After starting Diclofenac the patient began experiencing various side effects, including: Rocky Mountain Spotted Fever, Pyrexia, Nausea, Bacteraemia, Petechiae, Cyanosis, Pulse Abnormal, Abdominal Tenderness, DehydrationAdditional drugs used concurrently:
  • Ampicillin
The patient was hospitalized. Although Diclofenac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rocky Mountain Spotted Fever, may still occur.
Diclofenac Side Effect Report#9890947
Restlessness, Abdominal Pain Upper, Blood Pressure Decreased, Acute Coronary Syndrome, Acute Myocardial Infarction, Heart Rate Increased
This Restlessness problem was reported by a physician from IL. A 51-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On NS this consumer started treatment with Diclofenac (diclofenac) (dosage: NA). The following drugs were being taken at the same time: NA. When using Diclofenac (diclofenac), the patient experienced the following unwanted symptoms/side effects: Restlessness, Abdominal Pain Upper, Blood Pressure Decreased, Acute Coronary Syndrome, Acute Myocardial Infarction, Heart Rate IncreasedThe 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 Restlessness, may become evident only after a product is in use by the general population.
Diclofenac Side Effect Report#9888639
Poisoning, Exposure Via Ingestion, Completed Suicide
This Poisoning side effect was reported by a consumer or non-health professional from US. A 50-year-old patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diclofenac Sodium Extended-release (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Conjugated Estrogens
  • Citalopram
  • Tramadol
  • Procet
  • Lisinopril
  • Pregabalin
.After starting to take Diclofenac Sodium Extended-release the consumer reported adverse symptoms, such as: Poisoning, Exposure Via Ingestion, Completed SuicideThese side effects may potentially be related to Diclofenac Sodium Extended-release.
Diclofenac Side Effect Report#9887441
Erythema Multiforme
This is a report of a 52-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Diclofenac (dosage: NA, start time:
Feb 05, 2010), combined with: NA. and developed a serious reaction and side effect(s): Erythema Multiforme after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac treatment in male patients, resulting in Erythema Multiforme side effect. The patient was hospitalized.
Diclofenac Side Effect Report#9882572
Amnesia, Disorientation, Panic Attack, Fatigue
This report suggests a potential Diclofenacnatrium Actavis Amnesia side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: NA and used Diclofenacnatrium Actavis (dosage: NA) starting 201305. After starting Diclofenacnatrium Actavis the patient began experiencing various side effects, including: Amnesia, Disorientation, Panic Attack, FatigueAdditional drugs used concurrently: NA. Although Diclofenacnatrium Actavis demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Amnesia, may still occur.
Diclofenac Side Effect Report#9877993
Abdominal Pain Upper, Gastric Disorder, Dyspepsia, Nausea, Decreased Appetite
This Abdominal Pain Upper problem was reported by a physician from IT. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: musculoskeletal pain,arthralgia. On
Nov 16, 2013 this consumer started treatment with Diclofenac (dosage: 1 Df Daily). The following drugs were being taken at the same time:
  • Targin (1 Df)
When using Diclofenac, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain Upper, Gastric Disorder, Dyspepsia, Nausea, Decreased AppetiteThe 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 Abdominal Pain Upper, may become evident only after a product is in use by the general population.
Diclofenac Side Effect Report#9875320
Completed Suicide, Exposure Via Ingestion
This Completed Suicide side effect was reported by a pharmacist from US. A 50-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diclofenac (drug dosage: (df Oral)), which was initiated on NS. Concurrently used drugs:
  • Citalopram ((df Oral))
  • Acetaminophen W/hydrocodone ((df Oral))
  • Lisinopril ((df Oral))
  • Pregabalin ((df Oral))
  • Tramadol ((df Oral))
  • Conjugated Estrogens ((df Oral))
.After starting to take Diclofenac the consumer reported adverse symptoms, such as: Completed Suicide, Exposure Via IngestionThese side effects may potentially be related to Diclofenac.
Diclofenac Side Effect Report#9875286
Completed Suicide, Exposure Via Ingestion
This is a report of a 47-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Diclofenac (dosage: Df Po, start time: NS), combined with:
  • Atenolol (Df Po)
  • Pioglitazone (Df Po)
  • Diazepam (Df Po)
  • Glibenclamide (Df Po)
  • Levothyroxine (Df Po)
  • Metformin (Df Po)
  • Amlodipine (Df Po)
  • Benazepril (Df Oral)
and developed a serious reaction and side effect(s): Completed Suicide, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diclofenac treatment in male patients, resulting in Completed Suicide side effect.


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The appearance of Diclofenac 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 Side Effects for Women?

Women Side EffectsReports
Diarrhoea 98
Abdominal Pain 93
Renal Failure Acute 70
Vomiting 65
Haemoglobin Decreased 60
Nausea 59
Anaemia 53
Gastrointestinal Disorder 52
Abdominal Pain Upper 48
Blood Creatinine Increased 46

What are common Diclofenac Side Effects for Men?

Men Side EffectsReports
Renal Failure Acute 82
Vomiting 62
Dyspnoea 55
Gastrointestinal Haemorrhage 51
Abdominal Pain 44
Malaise 43
Haemoglobin Decreased 42
Pruritus 41
Blood Creatinine Increased 40
Dehydration 40

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.

    Diclofenac 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 for You?

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    Diclofenac Safety Alerts, Active Ingredients, Usage Information

    NDC0093-0948
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDiclofenac Potassium
    NameDiclofenac Potassium
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since19980811
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)DICLOFENAC POTASSIUM
    Strength(s)50
    Unit(s)mg/1
    Pharma ClassCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammato

    More About Diclofenac

    Side Effects reported to FDA: 2859

    Diclofenac 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]

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