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Nimesulide Side Effects

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Common Nimesulide Side Effects


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

Anaemia (10)
Hepatotoxicity (6)
Acute Hepatic Failure (6)
Hepatic Failure (5)
Bone Marrow Failure (4)
Metabolic Acidosis (4)
Gastrointestinal Ulcer (3)
Erythema (3)
Arthropathy (3)
Angioedema (3)
Liver Transplant (3)
Malaise (3)
Urticaria (3)
Pruritus (3)
Tongue Oedema (2)
Weight Decreased (2)
Rheumatoid Arthritis (2)
Pain In Extremity (2)
Osteoarthritis (2)
Pyrexia (2)

➢ 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.

Nimesulide Side Effects Reported to FDA



Nimesulide Side Effect Report#9880833
Angioedema
This is a report of a 36-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: tooth extraction, who was treated with Nimesulide (dosage: 200 Mg/day, start time:
Jan 21, 2014), combined with:
  • Augmentin (2 G/day)
and developed a serious reaction and side effect(s): Angioedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nimesulide treatment in male patients, resulting in Angioedema side effect. The patient was hospitalized.
Nimesulide Side Effect Report#9690398
Rash Papular
This report suggests a potential Nimesulide Rash Papular side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: erysipelas and used Nimesulide (dosage: 2 Df/day) starting
Oct 08, 2013. After starting Nimesulide the patient began experiencing various side effects, including: Rash PapularAdditional drugs used concurrently:
  • Teicoplanin (2 Df/day)
  • Valaciclovir (3 Df/day)
  • Perfalgan (Unk)
The patient was hospitalized. Although Nimesulide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash Papular, may still occur.
Nimesulide Side Effect Report#9685094
Angioedema, Erythema, Pruritus, Urticaria
This Angioedema problem was reported by a health professional from IT. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: toothache,tooth extraction. On 201308 this consumer started treatment with Nimesulide (dosage: 1 Df, Complete). The following drugs were being taken at the same time:
  • Amoxicillin\clavulanate Potassium (2 Df, Complete)
  • Oki (1 Df, Complete)
  • Ferrograd C (Unk)
  • Folic Acid (Unk)
When using Nimesulide, the patient experienced the following unwanted symptoms/side effects: Angioedema, Erythema, Pruritus, UrticariaThe 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 Angioedema, may become evident only after a product is in use by the general population.
Nimesulide Side Effect Report#9664230
Anaemia, Epistaxis, Hypocoagulable State
This Anaemia side effect was reported by a physician from IT. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: venous ulcer pain,atrial fibrillation.The patient was prescribed Nimesulide (drug dosage: NA), which was initiated on
Jan 01, 2011. Concurrently used drugs:
  • Amiodarone (1 Dosage Forms Daily;)
  • Coumadin
  • Furosemide
.After starting to take Nimesulide the consumer reported adverse symptoms, such as: Anaemia, Epistaxis, Hypocoagulable StateThese side effects may potentially be related to Nimesulide. The patient was hospitalized.
Nimesulide Side Effect Report#9659360
Anaemia, Metabolic Acidosis, Gastrointestinal Ulcer, Bone Marrow Failure
This is a report of a 54-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: neck pain,osteoarthritis, who was treated with Nimesulide (dosage: 1 Df Daily, start time:
Jul 03, 2013), combined with:
  • Ibuprofen (1 Df Daily)
and developed a serious reaction and side effect(s): Anaemia, Metabolic Acidosis, Gastrointestinal Ulcer, Bone Marrow Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nimesulide treatment in female patients, resulting in Anaemia side effect.
Nimesulide Side Effect Report#9652825
Epistaxis, Hypocoagulable State, Anaemia
This report suggests a potential Nimesulide Epistaxis side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: venous ulcer pain,atrial fibrillation and used Nimesulide (dosage: Unk) starting
Oct 04, 2013. After starting Nimesulide the patient began experiencing various side effects, including: Epistaxis, Hypocoagulable State, AnaemiaAdditional drugs used concurrently:
  • Cordarone (1 Ot, Qd)
  • Coumadin (Unk)
  • Coumadin (Unk)
  • Lasix
The patient was hospitalized. Although Nimesulide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epistaxis, may still occur.
Nimesulide Side Effect Report#9648981
Anaemia, Metabolic Acidosis, Gastroduodenal Ulcer, Bone Marrow Failure
This Anaemia problem was reported by a health professional from IT. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: neck pain,osteoarthritis. On
Jul 03, 2013 this consumer started treatment with Nimesulide (dosage: 1 Df, Daily). The following drugs were being taken at the same time:
  • Ibuprofen (1 Df, Daily)
When using Nimesulide, the patient experienced the following unwanted symptoms/side effects: Anaemia, Metabolic Acidosis, Gastroduodenal Ulcer, Bone Marrow FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaemia, may become evident only after a product is in use by the general population.
Nimesulide Side Effect Report#9645937
Anaemia, Metabolic Acidosis, Gastrointestinal Ulcer, Bone Marrow Failure
This Anaemia side effect was reported by a physician from IT. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: neck pain,osteoarthritis.The patient was prescribed Nimesulide (drug dosage: 1 Dosage Forms Daily;), which was initiated on
Jul 03, 2013. Concurrently used drugs:
  • Ibuprofen
.After starting to take Nimesulide the consumer reported adverse symptoms, such as: Anaemia, Metabolic Acidosis, Gastrointestinal Ulcer, Bone Marrow FailureThese side effects may potentially be related to Nimesulide.
Nimesulide Side Effect Report#9644038
Metabolic Acidosis, Bone Marrow Failure, Anaemia, Gastrointestinal Ulcer
This is a report of a 54-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: neck pain,osteoarthritis, who was treated with Nimesulide (dosage: 1 Ukn, Qd (one Posological Unit, start time:
Jul 03, 2013), combined with:
  • Ibuprofen (1 Ukn, Qd (one Posological Unit))
and developed a serious reaction and side effect(s): Metabolic Acidosis, Bone Marrow Failure, Anaemia, Gastrointestinal Ulcer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nimesulide treatment in female patients, resulting in Metabolic Acidosis side effect.
Nimesulide Side Effect Report#9639667
Angioedema, Urticaria
This report suggests a potential Nimesulide Angioedema side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: tooth abscess and used Nimesulide (dosage: 1 Df, Prn) starting
Sep 23, 2013. After starting Nimesulide the patient began experiencing various side effects, including: Angioedema, UrticariaAdditional drugs used concurrently:
  • Amoxicillin/clavulanic Acid (2 G/day)
  • Diclofenac (1 Df, Prn)
  • Oki (1 Df, Prn)
Although Nimesulide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Angioedema, may still occur.
Nimesulide Side Effect Report#9448084
Hypotension, Rectal Haemorrhage
This Hypotension problem was reported by a health professional from IT. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chest pain. On
May 30, 2013 this consumer started treatment with Nimesulide (dosage: 1 Df, Complete). The following drugs were being taken at the same time:
  • Ibuprofen (1 Df, Complete)
  • Diltiazem
When using Nimesulide, the patient experienced the following unwanted symptoms/side effects: Hypotension, Rectal HaemorrhageThe 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 Hypotension, may become evident only after a product is in use by the general population.
Nimesulide Side Effect Report#8803853
Anaemia, Gastric Ulcer, Erosive Oesophagitis
This Anaemia side effect was reported by a physician from IT. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: headache,osteoporosis.The patient was prescribed Nimesulide (drug dosage: NA), which was initiated on
Feb 01, 2011. Concurrently used drugs:
  • Alendronate Sodium
  • Nebivolol
.After starting to take Nimesulide the consumer reported adverse symptoms, such as: Anaemia, Gastric Ulcer, Erosive OesophagitisThese side effects may potentially be related to Nimesulide. The patient was hospitalized.
Nimesulide Side Effect Report#8782860
Erosive Oesophagitis, Serum Ferritin Decreased, Melaena, Anaemia, Gastric Ulcer
This is a report of a 62-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: headache,osteoporosis, who was treated with Nimesulide (dosage: 110 Mg, start time:
Feb 01, 2011), combined with:
  • Alendronate (70 Mg, Weekly)
  • Nebivolol
and developed a serious reaction and side effect(s): Erosive Oesophagitis, Serum Ferritin Decreased, Melaena, Anaemia, Gastric Ulcer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nimesulide treatment in female patients, resulting in Erosive Oesophagitis side effect. The patient was hospitalized.
Nimesulide Side Effect Report#8433432-5
Confusional State, Inadequate Diet, Pruritus, Erythema
This report suggests a potential Nimesulide Confusional State side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from Brazil was diagnosed with the following symptoms/conditions: osteoarthritis,arthralgia and used Nimesulide (dosage: NA) starting
May 27, 2012. After starting Nimesulide the patient began experiencing various side effects, including: Confusional State, Inadequate Diet, Pruritus, ErythemaAdditional drugs used concurrently:
  • Acetaminophen W/ Codeine
  • Dipyrone Tab
Although Nimesulide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Confusional State, may still occur.
Nimesulide Side Effect Report#8421530-1
Prostatic Disorder, Hearing Impaired
This Prostatic Disorder problem was reported by a consumer or non-health professional from Brazil. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On
Apr 10, 2012 this consumer started treatment with Nimesulide (dosage: NA). The following drugs were being taken at the same time:
  • Remicade
  • Ranitidine
  • Hydroxychloroquine Sulfate
  • Methotrexate
  • Prednisone Tab
  • Remicade
When using Nimesulide, the patient experienced the following unwanted symptoms/side effects: Prostatic Disorder, Hearing ImpairedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Prostatic Disorder, may become evident only after a product is in use by the general population.
Nimesulide Side Effect Report#8345820-6
Uterine Disorder
This Uterine Disorder side effect was reported by a consumer or non-health professional from Brazil. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nimesulide (drug dosage: Unk), which was initiated on
Jun 01, 2011. Concurrently used drugs:
  • Prednisone Tab (Unk)
  • Enbrel (Unk)
.After starting to take Nimesulide the consumer reported adverse symptoms, such as: Uterine DisorderThese side effects may potentially be related to Nimesulide.
Nimesulide Side Effect Report#8229860-3
Nephrolithiasis, Walking Disability, Injection Site Discolouration, Renal Cyst, Arthropathy, Pain
This is a report of a female patient (weight: NA) from Brazil, suffering from the following health symptoms/conditions: NA, who was treated with Nimesulide (dosage: Unk, start time:
Jan 01, 2012), combined with:
  • Enbrel (50 Mg, Weekly,powder And Solvent For Solution For Injection)
  • Captopril (25 Mg, Unk)
  • Methotrexate (Unk)
  • Cyclobenzaprine Hcl (Unk)
  • Sodium Carbonate (Unk)
  • Enbrel (Unk,solution For Injection In Pre-filled Pen)
  • Metformin Hcl (850 Mg, Unk)
  • Aspirin (100 Mg, Unk)
and developed a serious reaction and side effect(s): Nephrolithiasis, Walking Disability, Injection Site Discolouration, Renal Cyst, Arthropathy, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nimesulide treatment in female patients, resulting in Nephrolithiasis side effect.
Nimesulide Side Effect Report#8164181-9
Somnolence, Muscle Fatigue, Malaise, Wound, Nausea, Arthropathy, Asthenia, Nasopharyngitis, Blood Cholesterol Increased
This report suggests a potential Nimesulide Somnolence side effect(s) that can have serious consequences. A female patient (weight: NA) from Brazil was diagnosed with the following symptoms/conditions: inflammation,osteoarthritis and used Nimesulide (dosage: NA) starting NS. After starting Nimesulide the patient began experiencing various side effects, including: Somnolence, Muscle Fatigue, Malaise, Wound, Nausea, Arthropathy, Asthenia, Nasopharyngitis, Blood Cholesterol IncreasedAdditional drugs used concurrently:
  • Sodium Chloride
  • Humira
  • Synthroid
  • Risedronate Sodium
  • Arava
  • Humira
  • Calcium Phosphate W/colecalciferol (400/600 Mg)
  • Deflazacort
Although Nimesulide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnolence, may still occur.
Nimesulide Side Effect Report#8142623-2
Arthritis, Osteoarthritis, Joint Effusion, Synovitis, Female Sterilisation, Foreign Body, Postoperative Wound Infection, Purulent Discharge
This Arthritis problem was reported by a physician from Brazil. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2007 this consumer started treatment with Nimesulide (dosage: NA). The following drugs were being taken at the same time:
  • Prednisone Tab
  • Cyclobenzaprine
  • Humira
  • Cyclobenzaprine
  • Arava
  • Arava
  • Tramadol Hydrochloride
  • Fluoxetine
When using Nimesulide, the patient experienced the following unwanted symptoms/side effects: Arthritis, Osteoarthritis, Joint Effusion, Synovitis, Female Sterilisation, Foreign Body, Postoperative Wound Infection, Purulent DischargeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthritis, may become evident only after a product is in use by the general population.
Nimesulide Side Effect Report#8078319-5
Road Traffic Accident, Skin Graft, Extremity Necrosis
This Road Traffic Accident side effect was reported by a consumer or non-health professional from Brazil. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: extremity necrosis,hypertension.The patient was prescribed Nimesulide (nimesulide) (nimesulide) (drug dosage: 200 Mg (100 Mg, 2 In 1 D), Per Oral), which was initiated on
Jan 01, 2011. Concurrently used drugs:
  • Benicar (20 Mg (20 Mg, 1 In 1 D), Per Oral, 40 Mg (40 Mg, 1 In 1 D), Per Oral)
  • Benicar (20 Mg (20 Mg, 1 In 1 D), Per Oral, 40 Mg (40 Mg, 1 In 1 D), Per Oral)
  • Cephalexin (2000 Mg (500 Mg, 4 In 1 D), Per Oral)
.After starting to take Nimesulide (nimesulide) (nimesulide) the consumer reported adverse symptoms, such as: Road Traffic Accident, Skin Graft, Extremity NecrosisThese side effects may potentially be related to Nimesulide (nimesulide) (nimesulide). The patient was hospitalized.
Nimesulide Side Effect Report#8064410-6
Renal Failure Acute, Osteomyelitis, Nephritic Syndrome
This is a report of a 57-year-old male patient (weight: NA) from Italy, suffering from the following health symptoms/conditions: NA, who was treated with Nimesulide (dosage: NA, start time:
Sep 01, 2011), combined with:
  • Tizanidine Hcl
  • Cubicin
  • Ramipril
and developed a serious reaction and side effect(s): Renal Failure Acute, Osteomyelitis, Nephritic Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nimesulide treatment in male patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Nimesulide Side Effect Report#8048083-4
Oedema Peripheral, Rheumatoid Arthritis, Joint Prosthesis User, Joint Swelling
This report suggests a potential Nimesulide Oedema Peripheral side effect(s) that can have serious consequences. A 43-year-old female patient (weight: NA) from Brazil was diagnosed with the following symptoms/conditions: NA and used Nimesulide (dosage: Unk) starting
Mar 01, 2003. After starting Nimesulide the patient began experiencing various side effects, including: Oedema Peripheral, Rheumatoid Arthritis, Joint Prosthesis User, Joint SwellingAdditional drugs used concurrently:
  • Enbrel (50 Mg, Weekly)
  • Pantoprazole (Unk)
  • Prednisone (Unk)
  • Methotrexate (Unk)
  • Propan (Unk)
Although Nimesulide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oedema Peripheral, may still occur.
Nimesulide Side Effect Report#7995384-1
Pyrexia, Laryngitis, Osteoarthritis, Pharyngitis, Anaemia, Weight Decreased, Mass
This Pyrexia problem was reported by a consumer or non-health professional from Brazil. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On
Dec 19, 2010 this consumer started treatment with Nimesulide (dosage: NA). The following drugs were being taken at the same time:
  • Deflazacort
  • Humira
  • Glucosamine
When using Nimesulide, the patient experienced the following unwanted symptoms/side effects: Pyrexia, Laryngitis, Osteoarthritis, Pharyngitis, Anaemia, Weight Decreased, MassThe 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 Pyrexia, may become evident only after a product is in use by the general population.
Nimesulide Side Effect Report#7965078-7
Gastritis Erosive, Gastrointestinal Erosion, Erosive Duodenitis
This Gastritis Erosive side effect was reported by a physician from Russian Federation. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nimesulide (drug dosage: NA), which was initiated on
Jan 23, 2006. Concurrently used drugs:
  • Actemra
  • Actemra (Dosage From Reported As Flacon.)
  • Ranitidine Hcl
  • Chloroquine
.After starting to take Nimesulide the consumer reported adverse symptoms, such as: Gastritis Erosive, Gastrointestinal Erosion, Erosive DuodenitisThese side effects may potentially be related to Nimesulide. The patient was hospitalized.
Nimesulide Side Effect Report#7957250-7
Bladder Transitional Cell Carcinoma
This is a report of a 68-year-old male patient (weight: NA) from Czech Republic, suffering from the following health symptoms/conditions: NA, who was treated with Nimesulide (dosage: NA, start time:
Nov 11, 2008), combined with:
  • Losartan Potassium
  • Hydrochlorothiazide
  • Ibuprofen
  • Vildagliptin
  • Acetaminophen
  • Actos (30 Mg (30 Mg, 1 In 1 D), Per Oral)
  • Omeprazole
  • Diclophenac (diclofenac Sodium)
and developed a serious reaction and side effect(s): Bladder Transitional Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nimesulide treatment in male patients, resulting in Bladder Transitional Cell Carcinoma side effect. The patient was hospitalized.


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The appearance of Nimesulide 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.

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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.

    Nimesulide 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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