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Nimesulide Side Effects

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.

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.

Nimesulide Side Effects Reported to FDA

The following 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.


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.
Angioedema
This is a report of a 36-year-old male patient (weight: NA) from IT, suffering from the following 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). The consumer presented with:
  • Angioedema
which developed 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.

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. Soon after starting Nimesulide the patient began experiencing various side effects, including:
  • Rash Papular
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.

Angioedema, Erythema, Pruritus, Urticaria
This Angioedema, Erythema, Pruritus, Urticaria 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 commencing Nimesulide, the patient experienced the following unwanted symptoms/side effects:
  • Angioedema
  • Erythema
  • Pruritus
  • Urticaria
The 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.

Anaemia, Epistaxis, Hypocoagulable State
This is a report of a 82-year-old female patient (weight: NA) from IT. The patient developed the following symptoms/conditions: venous ulcer pain,atrial fibrillation and was treated with Nimesulide (dosage: NA) starting Jan 01, 2011. Concurrently used drugs:
  • Amiodarone (1 Dosage Forms Daily;)
  • Coumadin
  • Furosemide
Soon after that, the consumer experienced the following side effects:
  • Anaemia
  • Epistaxis
  • Hypocoagulable State
The patient was hospitalized. This opens a possibility that Nimesulide treatment could cause the above reactions, including anaemia, and some female subjects may be more susceptible.


Anaemia, Metabolic Acidosis, Gastrointestinal Ulcer, Bone Marrow Failure
A 54-year-old female patient (weight: NA) from IT with the following symptoms/conditions: neck pain,osteoarthritis started Nimesulide treatment (dosage: 1 Df Daily) on Jul 03, 2013. Soon after starting Nimesulide treatment, the subject experienced various side effects, including:
  • Anaemia
  • Metabolic Acidosis
  • Gastrointestinal Ulcer
  • Bone Marrow Failure
Concurrently used drugs:
  • Ibuprofen (1 Df Daily)
This finding indicates that some female patients could be more vulnerable to Nimesulide.

Epistaxis, Hypocoagulable State, Anaemia
A 82-year-old female patient from IT (weight: NA) experienced symptoms, such as: venous ulcer pain,atrial fibrillation and was treated with Nimesulide(dosage: Unk). The treatment was initiated on Oct 04, 2013. After that a consumer reported the following side effect(s):
  • Epistaxis
  • Hypocoagulable State
  • Anaemia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Nimesulide efficacy:
  • Cordarone (1 Ot, Qd)
  • Coumadin (Unk)
  • Coumadin (Unk)
  • Lasix
The patient was hospitalized.

Anaemia, Metabolic Acidosis, Gastroduodenal Ulcer, Bone Marrow Failure
In this report, Nimesulide was administered for the following condition: neck pain,osteoarthritis.A 54-year-old female consumer from IT (weight: NA) started Nimesulide treatment (dosage: 1 Df, Daily) on Jul 03, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Anaemia
  • Metabolic Acidosis
  • Gastroduodenal Ulcer
  • Bone Marrow Failure
A possible interaction with other drugs could have contributed to this reaction:
  • Ibuprofen (1 Df, Daily)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Nimesulide treatment could be related to the listed above side effect(s).

Anaemia, Metabolic Acidosis, Gastrointestinal Ulcer, Bone Marrow Failure
This is a report of the following Nimesulide side effect(s):
  • Anaemia
  • Metabolic Acidosis
  • Gastrointestinal Ulcer
  • Bone Marrow Failure
A 54-year-old female patient from IT (weight: NA) presented with the following condition: neck pain,osteoarthritis and received a treatment with Nimesulide (dosage: 1 Dosage Forms Daily;) starting: Jul 03, 2013.The following concurrently used drugs could have generated interactions:
  • Ibuprofen
This report suggests that a Nimesulide treatment could be associated with the listed above side effect(s).

Metabolic Acidosis, Bone Marrow Failure, Anaemia, Gastrointestinal Ulcer
This Nimesulide report was submitted by a 54-year-old female consumer from IT (weight: NA). The patient was diagnosed with: neck pain,osteoarthritis and Nimesulide was administered (dosage: 1 Ukn, Qd (one Posological Unit) starting: Jul 03, 2013. The consumer developed a set of symptoms:
  • Metabolic Acidosis
  • Bone Marrow Failure
  • Anaemia
  • Gastrointestinal Ulcer
Other drugs used simultaneously:
  • Ibuprofen (1 Ukn, Qd (one Posological Unit))
Those unexpected symptoms could be linked to a Nimesulide treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Angioedema, Urticaria
This is a report of a possible correlation between Nimesulide use and the following symptoms/side effect(s):
  • Angioedema
  • Urticaria
which could contribute to an assessment of Nimesulide risk profile.A 52-year-old female consumer from IT (weight: NA) was suffering from tooth abscess and was treated with Nimesulide (dosage: 1 Df, Prn) starting Sep 23, 2013.Other concurrent medications:
  • Amoxicillin/clavulanic Acid (2 G/day)
  • Diclofenac (1 Df, Prn)
  • Oki (1 Df, Prn)


Hypotension, Rectal Haemorrhage
A 65-year-old male patient from IT (weight: NA) presented with the following symptoms: chest pain and after a treatment with Nimesulide (dosage: 1 Df, Complete) experienced the following side effect(s):
  • Hypotension
  • Rectal Haemorrhage
The treatment was started on May 30, 2013. Nimesulide was used in combination with the following drugs:
  • Ibuprofen (1 Df, Complete)
  • Diltiazem
The patient was hospitalized.This report could alert potential Nimesulide consumers.

Anaemia, Gastric Ulcer, Erosive Oesophagitis
In this report, a 62-year-old female patient from IT (weight: NA) was affected by a possible Nimesulide side effect.The patient was diagnosed with headache,osteoporosis. After a treatment with Nimesulide (dosage: NA, start date: Feb 01, 2011), the patient experienced the following side effect(s):
  • Anaemia
  • Gastric Ulcer
  • Erosive Oesophagitis
The following simultaneously used drugs could have led to this reaction:
  • Alendronate Sodium
  • Nebivolol
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Nimesulide treatment.

Erosive Oesophagitis, Serum Ferritin Decreased, Melaena, Anaemia, Gastric Ulcer
This is a report of a 62-year-old female patient from IT (weight: NA), who used Nimesulide (dosage: 110 Mg) for a treatment of headache,osteoporosis. After starting a treatment on Feb 01, 2011, the patient experienced the following side effect(s):
  • Erosive Oesophagitis
  • Serum Ferritin Decreased
  • Melaena
  • Anaemia
  • Gastric Ulcer
The following drugs could possibly have interacted with the Nimesulide treatment
  • Alendronate (70 Mg, Weekly)
  • Nebivolol
The patient was hospitalized.Taken together, these observations suggest that a Nimesulide treatment could be related to side effect(s), such as Erosive Oesophagitis, Serum Ferritin Decreased, Melaena, Anaemia, Gastric Ulcer.

Confusional State, Inadequate Diet, Pruritus, Erythema
This confusional state side effect was reported by a consumer or non-health professional from BRAZIL. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoarthritis,arthralgia. The patient was prescribed Nimesulide (dosage: NA), which was started on May 27, 2012. Concurrently used drugs:
  • Acetaminophen W/ Codeine
  • Dipyrone Tab
When starting to take Nimesulide the consumer reported the following symptoms:
  • Confusional State
  • Inadequate Diet
  • Pruritus
  • Erythema
These side effects may potentially be related to Nimesulide.

Prostatic Disorder, Hearing Impaired
This is a Nimesulide side effect report of a male patient (weight:NA) from BRAZIL, suffering from the following symptoms/conditions: rheumatoid arthritis, who was treated with Nimesulide (dosage:NA, start time: Apr 10, 2012), combined with:
  • Remicade
  • Ranitidine
  • Hydroxychloroquine Sulfate
  • Methotrexate
  • Prednisone Tab
  • Remicade
, and developed a serious reaction and a prostatic disorder side effect. The patient presented with:
  • Prostatic Disorder
  • Hearing Impaired
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Nimesulide treatment in male patients suffering from rheumatoid arthritis, resulting in prostatic disorder.

Uterine Disorder
This report suggests a potential Nimesulide uterine disorder side effect(s) that can have serious consequences. A female patient from BRAZIL (weight:NA) was diagnosed with the following health condition(s): NA and used Nimesulide (dosage: Unk) starting Jun 01, 2011. Soon after starting Nimesulide the patient began experiencing various side effects, including:
  • Uterine Disorder
Drugs used concurrently:
  • Prednisone Tab (Unk)
  • Enbrel (Unk)
Although Nimesulide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as uterine disorder, may still occur.

Nephrolithiasis, Walking Disability, Injection Site Discolouration, Renal Cyst, Arthropathy, Pain
This nephrolithiasis problem was reported by a consumer or non-health professional from BRAZIL. A female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Jan 01, 2012 a consumer started treatment with Nimesulide (dosage: Unk). The following drugs/medications were being taken at the same time:
  • 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)
When commencing Nimesulide, the patient experienced the following unwanted symptoms /side effects:
  • Nephrolithiasis
  • Walking Disability
  • Injection Site Discolouration
  • Renal Cyst
  • Arthropathy
  • Pain
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as nephrolithiasis, may become evident only after a product is in use by the general population.

Somnolence, Muscle Fatigue, Malaise, Wound, Nausea, Arthropathy, Asthenia, Nasopharyngitis, Blood Cholesterol Increased
This is a Nimesulide side effect report of a female patient (weight: NA) from BRAZIL. The patient developed the following symptoms/conditions: inflammation,osteoarthritis and was treated with Nimesulide (dosage: NA) starting NS. Concurrently used drugs:
  • Sodium Chloride
  • Humira
  • Synthroid
  • Risedronate Sodium
  • Arava
  • Humira
  • Calcium Phosphate W/colecalciferol (400/600 Mg)
  • Deflazacort
Soon after that, the consumer experienced the following of symptoms:
  • Somnolence
  • Muscle Fatigue
  • Malaise
  • Wound
  • Nausea
  • Arthropathy
  • Asthenia
  • Nasopharyngitis
  • Blood Cholesterol Increased
This opens a possibility that Nimesulide could cause somnolence and that some female patients may be more susceptible.

Arthritis, Osteoarthritis, Joint Effusion, Synovitis, Female Sterilisation, Foreign Body, Postoperative Wound Infection, Purulent Discharge
A female patient (weight: NA) from BRAZIL with the following symptoms: NA started Nimesulide treatment (dosage: NA) on Jan 01, 2007. Soon after starting Nimesulide treatment, the consumer experienced several side effects, including:
  • Arthritis
  • Osteoarthritis
  • Joint Effusion
  • Synovitis
  • Female Sterilisation
  • Foreign Body
  • Postoperative Wound Infection
  • Purulent Discharge
. Concurrently used drugs:
  • Prednisone Tab
  • Cyclobenzaprine
  • Humira
  • Cyclobenzaprine
  • Arava
  • Arava
  • Tramadol Hydrochloride
  • Fluoxetine
This finding indicates that some patients can be more vulnerable to developing Nimesulide side effects, such as arthritis.

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) (dosage: 200 Mg (100 Mg, 2 In 1 D), Per Oral), which was started 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)
.When starting to take Nimesulide (nimesulide) (nimesulide) the consumer reported symptoms, such as:
  • Road Traffic Accident
  • Skin Graft
  • Extremity Necrosis
These side effects may potentially be related to Nimesulide (nimesulide) (nimesulide). The patient was hospitalized.

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 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). The consumer presented with:
  • Renal Failure Acute
  • Osteomyelitis
  • Nephritic Syndrome
which developed 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.

Oedema Peripheral, Rheumatoid Arthritis, Joint Prosthesis User, Joint Swelling
This report suggests a potential Nimesulide Oedema Peripheral, Rheumatoid Arthritis, Joint Prosthesis User, Joint Swelling 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. Soon after starting Nimesulide the patient began experiencing various side effects, including:
  • Oedema Peripheral
  • Rheumatoid Arthritis
  • Joint Prosthesis User
  • Joint Swelling
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.

Pyrexia, Laryngitis, Osteoarthritis, Pharyngitis, Anaemia, Weight Decreased, Mass
This Pyrexia, Laryngitis, Osteoarthritis, Pharyngitis, Anaemia, Weight Decreased, Mass 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 commencing Nimesulide, the patient experienced the following unwanted symptoms/side effects:
  • Pyrexia
  • Laryngitis
  • Osteoarthritis
  • Pharyngitis
  • Anaemia
  • Weight Decreased
  • Mass
The 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.

Gastritis Erosive, Gastrointestinal Erosion, Erosive Duodenitis
This is a report of a male patient (weight: NA) from RUSSIAN FEDERATION. The patient developed the following symptoms/conditions: NA and was treated with Nimesulide (dosage: NA) starting Jan 23, 2006. Concurrently used drugs:
  • Actemra
  • Actemra (Dosage From Reported As Flacon.)
  • Ranitidine Hcl
  • Chloroquine
Soon after that, the consumer experienced the following side effects:
  • Gastritis Erosive
  • Gastrointestinal Erosion
  • Erosive Duodenitis
The patient was hospitalized. This opens a possibility that Nimesulide treatment could cause the above reactions, including gastritis erosive, and some male subjects may be more susceptible.

Bladder Transitional Cell Carcinoma
A 68-year-old male patient (weight: NA) from CZECH REPUBLIC with the following symptoms/conditions: NA started Nimesulide treatment (dosage: NA) on Nov 11, 2008. Soon after starting Nimesulide treatment, the subject experienced various side effects, including:
  • Bladder Transitional Cell Carcinoma
Concurrently used drugs:
  • Losartan Potassium
  • Hydrochlorothiazide
  • Ibuprofen
  • Vildagliptin
  • Acetaminophen
  • Actos (30 Mg (30 Mg, 1 In 1 D), Per Oral)
  • Omeprazole
  • Diclophenac (diclofenac Sodium)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Nimesulide.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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