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Ketonal Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Dyspnoea, Chest Pain, Pruritus, Urticaria, Diplopia (7332928-7)
on Feb 21, 2011 Female from POLAND , weighting 176.4 lb, was diagnosed with
  • back pain
and was treated with Ketonal Forte. Directly after, patient experienced the unwanted or unexpected Ketonal side effects: dyspnoea, chest pain, pruritus, urticaria, diplopia. Ketonal Forte dosage: 300 Mg, Unk.
Associated medications used:
  • Mydocalm
Patient was hospitalized.

Hepatic Enzyme Increased (7332747-1)
Patient was taking Ketonal. Patient felt the following Ketonal side effects: hepatic enzyme increased on Feb 24, 2011 from RUSSIAN FEDERATION Additional patient health information: Female , 56 years of age, weighting 176.4 lb, . Ketonal dosage: N/A.
Multiple prescriptions taken:
  • Arava
  • Arava
  • Lidocaine
  • Movalis
  • Hydrocortisone
  • Novocain
  • Sirdalud
  • Omeprazole
Patient was hospitalized.

Abdominal Pain (7322952-2)
Adverse event was reported on Feb 23, 2011 by a Patient taking Ketonal (Dosage: N/A) . Location: UNITED STATES , 65 years of age, weighting 88.18 lb, After Ketonal was administered, patient encountered several Ketonal side effects: abdominal pain.
Multiple concurrent drugs taken:
  • Cisplatin (Last Inf:21dec10.)
  • Necitumumab
  • Gemcitabine Hcl (Last Inf:18jan2011.)
  • Theovent
  • Atrovent
  • Morphine Hcl Elixir
  • Morphine Sulfate
  • Miflonide
Patient was hospitalized.

Gastrointestinal Haemorrhage (7313992-8)
on Feb 21, 2011 Female from POLAND , weighting 143.3 lb, was diagnosed with
  • essential hypertension
and was treated with Ketonal Forte. Directly after, patient experienced the unwanted or unexpected Ketonal side effects: gastrointestinal haemorrhage. Ketonal Forte dosage: 300 Mg, Unk.
Associated medications used:
  • Mydocalm
  • Furosemide
  • Digoxin
  • Kalipoz
  • Zaldiar
  • Voltaren (100 Mg, Unk)
  • Aulin (200 Mg, Unk)
  • Alendronic Acid



Pruritus, Dyspnoea, Aphonia, Hypoaesthesia Oral, Anaphylactoid Reaction, Chest Pain, Anxiety (7312557-1)
on Feb 21, 2011 Female from POLAND , weighting 149.9 lb, was diagnosed with
  • back pain
and was treated with Ketonal Duo. Patient felt the following Ketonal side effects: pruritus, dyspnoea, aphonia, hypoaesthesia oral, anaphylactoid reaction, chest pain, anxiety. Ketonal Duo dosage: 150 Mg.
Multiple prescriptions taken:
  • Tetraratio (Unk)
  • Loratadyna (Unk)
  • Tetraratio


Abdominal Pain (7305172-7)
Patient was taking Ketonal. After Ketonal was administered, patient encountered several Ketonal side effects: abdominal pain on Feb 10, 2011 from POLAND Additional patient health information: Patient , weighting 88.18 lb, . Ketonal dosage: N/A.
Multiple concurrent drugs taken:
  • Theovent (300 Mg, Unk)
  • Morphin /00036303/ (200 Mg, Unk)
  • Atrovent
  • Gemcitabine Hydrochloride (800 Mg, Unk)
  • Cisplatin (800 Mg, Unk)
  • Polprazol (20 Mg, Daily (1/d))
  • Miflonide
  • Necitumumab (11f8) (ly3012211) (800 Mg, Unk)
Patient was hospitalized.

Angioedema (7250597-1)
Adverse event was reported on Jan 17, 2011 by a Female taking Ketonal (Dosage: N/A) . Location: RUSSIAN FEDERATION , 32 years of age, Directly after, patient experienced the unwanted or unexpected Ketonal side effects: angioedema. Patient was hospitalized.

Renal Failure, Mucosal Inflammation (7237508-X)
on Jan 19, 2011 Male from POLAND , 47 years of age, weighting 132.3 lb, was treated with Ketonal. Patient felt the following Ketonal side effects: renal failure, mucosal inflammation. Ketonal dosage: N/A.
Multiple prescriptions taken:
  • Duragesic-100
  • Sunitinib Malate (50 Mg, 1x/day)
Patient was hospitalized.

Hypotension, Loss Of Consciousness, Rash Macular (6483615-9)
on Dec 01, 2009 Female from POLAND , weighting 187.4 lb, was diagnosed with
  • renal colic
and was treated with Ketonal (ngx). After Ketonal was administered, patient encountered several Ketonal side effects: hypotension, loss of consciousness, rash macular. Ketonal (ngx) dosage: 100 Mg Daily.
Multiple concurrent drugs taken:
  • Nolicin
  • Urosept
  • Herbal Preparation
  • No-spa


Haematuria (6168328-5)
Patient was taking Ketonal (ngx) (keotprofen) 100mg. Directly after, patient experienced the unwanted or unexpected Ketonal side effects: haematuria on Apr 16, 2009 from POLAND Additional patient health information: Female , 49 years of age, weighting 163.1 lb, was diagnosed with
  • back pain
  • atrial fibrillation
and. Ketonal (ngx) (keotprofen) 100mg dosage: 300mg Daily Oral.
Associated medications used:
  • Acenocoumarol (acenocoumarol) (2 Mg Daily Oral)
  • Sotalol Hcl
  • Ramipril
Patient was hospitalized.

Arrhythmia, Blood Pressure Decreased, Bradycardia, Circulatory Collapse, Emotional Disorder, Hyperhidrosis, Pallor, Syncope (5160879-5)
Adverse event was reported on Nov 10, 2006 by a Male taking Ketonal (Dosage: 100 Mg, Intramuscular) was diagnosed with
  • groin pain
and. Location: POLAND , 26 years of age, Patient felt the following Ketonal side effects: arrhythmia, blood pressure decreased, bradycardia, circulatory collapse, emotional disorder, hyperhidrosis, pallor, syncope.
Multiple prescriptions taken:
  • Tramadol Hcl
Patient was hospitalized.

Blister, Erythema, Oedema (4791257-6)
on Sep 27, 2005 Female from CZECH REPUBLIC , 34 years of age, was diagnosed with
  • joint sprain
and was treated with Ketonal (ngx) (ketoprofen) Cream. After Ketonal was administered, patient encountered several Ketonal side effects: blister, erythema, oedema. Ketonal (ngx) (ketoprofen) Cream dosage: Bid, Local. Patient was hospitalized.

Conjunctivitis, Dyspnoea, Pyrexia, Toxic Epidermal Necrolysis, Urticaria (4676571-7)
on May 20, 2005 Male from , 21 years of age, weighting 176.4 lb, was diagnosed with
  • pain in extremity
and was treated with Ketonal (ngx)(ketoprofen) Capsule. Directly after, patient experienced the unwanted or unexpected Ketonal side effects: conjunctivitis, dyspnoea, pyrexia, toxic epidermal necrolysis, urticaria. Ketonal (ngx)(ketoprofen) Capsule dosage: 50 Mg, Oral.
Associated medications used:
  • Nutrition Supplement (nutrition Supplements)
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Ketonal Information

More About Ketonal

Side Effects reported to FDA: 13. View Ketonal Adverse Reports

Ketonal safety alerts: No

Reported deaths: 1

Reported hospitalizations: 6

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