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Leg (3)
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Dry Skin (2)
Swolen Feet (2)
Constipation (1)
DAFLON (1)
Decadron (1)
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Dafalgan Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 45 

Haematoma, International Normalised Ratio Increased, Fall, Pain, Atrial Fibrillation (8401755-1)
on May 14, 2012 Male from FRANCE , 85 years of age, was diagnosed with
  • pain
and was treated with Dafalgan Codeine (panadeine Co) (coated Tablet) (paracetamol, Codeine). Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: haematoma, international normalised ratio increased, fall, pain, atrial fibrillation. Dafalgan Codeine (panadeine Co) (coated Tablet) (paracetamol, Codeine) dosage: 6 Df (6 Df, 1 In 1 D).
Associated medications used:
  • Nitriderm (lyceryl Trinitrate)
  • Levothyroxine Sodium (1 Df (1 Df, 1 In 1 D))
  • Furosemide
  • Gaviscon
  • Previscan (fluindione) (fluindione) (1.25 Or 1.5 One In Two Days)
  • Crestor (1 Df (1 Df, 1 In 1 D))
  • Bisoprolol Fumarate
  • Repaglinide
Patient was hospitalized.

Fall, Skull Fractured Base, Haemorrhage, International Normalised Ratio Increased (8229851-2)
Patient was taking Dafalgan Caps 500 Mg. Patient felt the following Dafalgan side effects: fall, skull fractured base, haemorrhage, international normalised ratio increased on Mar 13, 2012 from FRANCE Additional patient health information: Male , 94 years of age, . Dafalgan Caps 500 Mg dosage: 1 Df: 2 Capsules.
Multiple prescriptions taken:
  • Rabeprazole Sodium (Gastro-resistant Tablet)
  • Bisoprolol Fumarate (Film-coated Tablet)
  • Coumadin (1df: 0.5 Df)
Patient was hospitalized.

Lumbar Spinal Stenosis, Haematoma (7711755-2)
Adverse event was reported on Aug 22, 2011 by a Male taking Dafalgan Codeine (Dosage: N/A) . Location: BELGIUM , weighting 209.4 lb, After Dafalgan was administered, patient encountered several Dafalgan side effects: lumbar spinal stenosis, haematoma.
Multiple concurrent drugs taken:
  • Diclofenac Sodium
  • Lipitor
  • Tramadol Hcl
  • Methotrexate
  • Golimumab
  • Methotrexate
  • Golimumab
  • Xenical
Patient was hospitalized.

Hyperhidrosis, Tachycardia, Pain In Extremity, Loss Of Consciousness, Hypotension, Hyperthermia (7570983-X)
on Jun 07, 2011 Male from DENMARK , 45 years of age, was treated with Dafalgan Codein (panadeine Co) (tablets) (panadeine Co). Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: hyperhidrosis, tachycardia, pain in extremity, loss of consciousness, hypotension, hyperthermia. Dafalgan Codein (panadeine Co) (tablets) (panadeine Co) dosage: N/A.
Associated medications used:
  • Escitalopram (20 Mg (10 Mg, 2 In 1 D), Oral)
  • Lexomil (bromazepam) (tablets) (bromazepam)
  • Tercian (cyamemazine) (cyamemazine)
  • Tramadol Hydrochloride (300 Mg (150 Mg, 2 In 1 D), Oral)
  • Xylocaine Visqueus (xylocain Viscos /02029501/) (gel) (xylocain Viscos



Fall, Dermatitis Allergic, Femoral Neck Fracture, Renal Failure Acute, Rash Erythematous (7558939-4)
on Jun 09, 2011 Female from GERMANY , 94 years of age, was treated with Dafalgan (paracetamol, Codeine Phosphate) (tablets) (paracetamol, Code. Patient felt the following Dafalgan side effects: fall, dermatitis allergic, femoral neck fracture, renal failure acute, rash erythematous. Dafalgan (paracetamol, Codeine Phosphate) (tablets) (paracetamol, Code dosage: N/A.
Multiple prescriptions taken:
  • Furosemide
  • Memantine
  • Memantine (10 Mg (10 Mg, 1 In 1 D), Oral; 5 Mg (5 Mg, 1 In 1 D), Oral)
  • Memantine (10 Mg (10 Mg, 1 In 1 D), Oral; 5 Mg (5 Mg, 1 In 1 D), Oral)
  • Cefuroxime (3000 Mg (1500 Mg, 2 In 1 D), Intravenous (not Otherwise Specified))
  • Levothyroxine Sodium (100 Microgram (100 Mcg, 1 In 1 D) Long Term Treatment-)
  • Aspirin Cardio (acetylsalicylic Acid) (tablets) (acetylsalicylic Acid)
  • Torsemide (10 Mg (10 Mg, 1 In 1 D); 25 Mg (25 Mg, 1 In 1 D))
Patient was hospitalized.

Chest Discomfort (7470050-X)
Patient was taking Dafalgan. After Dafalgan was administered, patient encountered several Dafalgan side effects: chest discomfort on May 09, 2011 from FRANCE Additional patient health information: Female , 48 years of age, weighting 167.6 lb, was diagnosed with
  • pain
  • spondylitis
and. Dafalgan dosage: 1 G, As Needed.
Multiple concurrent drugs taken:
  • Sulfasalazine (1000 Mg, 2x/day)
  • Trileptal (150 Mg, 3x/day)
  • Laroxyl (25 Mg (1 Df), 1x/day)
  • Levothyroxine Sodium (25 Ug (1 Df), 1x/day)


Chest Discomfort (7459876-6)
Adverse event was reported on Apr 29, 2011 by a Female taking Dafalgan (Dosage: 1 G, As Needed) was diagnosed with
  • pain
and. Location: FRANCE , 48 years of age, weighting 167.6 lb, Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: chest discomfort.
Associated medications used:
  • Laroxyl (25 Mg (1 Df), 1x/day)
  • Trileptal (150 Mg, 3x/day)
  • Salazopyrine (1000 Mg, 2x/day)
  • Levothyrox (25 Ug (1 Df), 1x/day)


Haemoglobin Decreased (7458558-4)
on May 02, 2011 Female from FRANCE , weighting 194.0 lb, was diagnosed with
  • arthralgia
  • hypertension
and was treated with Dafalgan. Patient felt the following Dafalgan side effects: haemoglobin decreased. Dafalgan dosage: 3 G.
Multiple prescriptions taken:
  • Eupressyl (120 Mg)
  • Xyzal (10 Mg)
  • Pradaxa (220 Mg)
  • Lovenox (4000 U)
  • Topalgic (300 Mg)
  • Hydergine (4.5 Mg)
  • Nisisco (160 Mg/25 Mg)
  • Tardyferon


Obsessive-compulsive Disorder, Depressed Mood, Anxiety (7446182-9)
on Apr 21, 2011 Male from SWITZERLAND , weighting 207.2 lb, was diagnosed with
  • headache
  • multiple sclerosis
and was treated with Dafalgan. After Dafalgan was administered, patient encountered several Dafalgan side effects: obsessive-compulsive disorder, depressed mood, anxiety. Dafalgan dosage: N/A.
Multiple concurrent drugs taken:
  • Rebif


Liver Injury, Rash Maculo-papular (7438133-8)
Patient was taking Dafalgan. Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: liver injury, rash maculo-papular on Apr 18, 2011 from FRANCE Additional patient health information: Female , 81 years of age, . Dafalgan dosage: Unk.
Associated medications used:
  • Celebrex (Unk)
  • Lyrica (Unk)
  • Amlodipine Besylate (Unk)
  • Amlodipine Besylate (Unk)
  • Acupan (Unk)
  • Pradaxa (Unk)
  • Kardegic (Unk)
  • Acupan (Unk)
Patient was hospitalized.

(7435949-9)
Adverse event was reported on Apr 19, 2011 by a Male taking Dafalgan (Dosage: N/A) . Location: SWITZERLAND , 61 years of age, .
Multiple prescriptions taken:
  • Prazine
  • Temesta
  • Seroquel (400 Mg Twice A Day In The Evening)
  • Seroquel
  • Depakene (1000-0-500 Mg Daily)
  • Buscopan
  • Seroquel
  • Seroquel


Gastroenteritis, Hypokalaemia, Blood Sodium Increased, Electrolyte Imbalance, Renal Failure Acute, Acidosis Hyperchloraemic (7435194-7)
on Apr 12, 2011 Male from SWITZERLAND , 62 years of age, was treated with Dafalgan. After Dafalgan was administered, patient encountered several Dafalgan side effects: gastroenteritis, hypokalaemia, blood sodium increased, electrolyte imbalance, renal failure acute, acidosis hyperchloraemic. Dafalgan dosage: N/A.
Multiple concurrent drugs taken:
  • Zestril
  • Calcium D3-mepha (1200mg/800 Iu Daily)
  • Spiralgin
  • Condrosulf
  • Neurontin
  • Seroquel Xr
  • Citalopram
Patient was hospitalized.

Systemic Sclerosis, Hepatic Steatosis, Gastritis Erosive (7434625-6)
on Apr 07, 2011 Female from SWITZERLAND , 59 years of age, weighting 218.3 lb, was treated with Dafalgan /00020001/. Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: systemic sclerosis, hepatic steatosis, gastritis erosive. Dafalgan /00020001/ dosage: Unk.
Associated medications used:
  • Etanercept
  • Pantozol /01263202/ (Unk)
  • Fraxiparin /00889603/ (Unk)
  • Fraxiparin /00889603/ (Unk)
  • Dafalgan /00020001/ (Unk)
  • Etanercept (50 Mg, Qwk)
  • Methotrexate Sodium (10-25 Mg Once Weekly)
Patient was hospitalized.

Decreased Appetite, Rash Pruritic, Escherichia Urinary Tract Infection, Weight Decreased, Shift To The Left, Constipation, Abdominal Pain Upper, Hypokalaemia, Cytolytic Hepatitis (7400584-5)
Patient was taking Dafalgan. Patient felt the following Dafalgan side effects: decreased appetite, rash pruritic, escherichia urinary tract infection, weight decreased, shift to the left, constipation, abdominal pain upper, hypokalaemia, cytolytic hepatitis on Apr 06, 2011 from SWITZERLAND Additional patient health information: Female , 86 years of age, . Dafalgan dosage: 1 G, 4x/day.
Multiple prescriptions taken:
  • Fentanyl (1 Df, 2x/week Every 3 Days)
  • Tolterodine Tartrate (4 Mg, 1x/day)
  • Januvia (100 Mg, 1x/day)
  • Motilium (10 Mg, 3x/day)
  • Zolpidem (5 Mg, 1x/day)
  • Remeron (30 Mg, 1x/day)
Patient was hospitalized.

Hypoglycaemia (7391046-2)
Adverse event was reported on Mar 22, 2011 by a Female taking Dafalgan (Dosage: N/A) . Location: SWITZERLAND , 58 years of age, weighting 251.3 lb, After Dafalgan was administered, patient encountered several Dafalgan side effects: hypoglycaemia.
Multiple concurrent drugs taken:
  • Tramadol Hydrochloride
  • Irfen
  • Physiotens
  • Singulair
  • Nasonex
  • Duspatalin
  • Seretide
  • Coaprovel


Abortion Missed (7383294-2)
on Feb 15, 2011 Female from SWITZERLAND , 36 years of age, was treated with Dafalgan. Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: abortion missed. Dafalgan dosage: N/A.
Associated medications used:
  • Relpax (40 Mg, Single)
  • Pantozol (40 Mg, 1x/day)


Dyspnoea, Dysphonia, Face Oedema, Dysphagia, Hypersensitivity, Angioedema, Lip Oedema (7375907-6)
on Mar 18, 2011 Female from FRANCE , 27 years of age, was diagnosed with
  • tonsillitis
and was treated with Dafalgan. Patient felt the following Dafalgan side effects: dyspnoea, dysphonia, face oedema, dysphagia, hypersensitivity, angioedema, lip oedema. Dafalgan dosage: 2tab Single Dose.
Multiple prescriptions taken:
  • Derinox
  • Domperidone (1tab Single Dose)
  • Augmentin (1g Single Dose)
Patient was hospitalized.

Bile Duct Stone, Gastritis, Hepatitis Acute, Abdominal Pain Upper (7356608-7)
Patient was taking Dafalgan. After Dafalgan was administered, patient encountered several Dafalgan side effects: bile duct stone, gastritis, hepatitis acute, abdominal pain upper on Mar 03, 2011 from SWITZERLAND Additional patient health information: Female , 51 years of age, was diagnosed with
  • back pain
and. Dafalgan dosage: 1 G, Qid.
Multiple concurrent drugs taken:
  • Sirdalud (2 Mg, Bid)
  • Bi-profenid (150 Mg, Qd)
  • Nexium (40 Mg, Qd)
  • Prednisone (Unk)
  • Ecofenac (75 Mg, Bid)
Patient was hospitalized.

Multi-organ Failure, Cardiac Arrest, Coma, Neoplasm Malignant, Renal Impairment, Hepatic Function Abnormal, Malaise (7348439-9)
Adverse event was reported on Mar 09, 2011 by a Male taking Dafalgan (Dosage: 1 G, Tid) was diagnosed with
  • bone pain
  • prostate cancer
and. Location: BELGIUM , 69 years of age, Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: multi-organ failure, cardiac arrest, coma, neoplasm malignant, renal impairment, hepatic function abnormal, malaise.
Associated medications used:
  • Androcur (50 Mg, Tid)
  • Zometa (5 Mg, Unk)
Patient was hospitalized.

Metabolic Acidosis, Hyperkalaemia, Ventricular Tachycardia, Renal Failure Acute (7342696-0)
on Mar 08, 2011 Female from FRANCE , 83 years of age, was diagnosed with
  • pain
and was treated with Dafalgan. Patient felt the following Dafalgan side effects: metabolic acidosis, hyperkalaemia, ventricular tachycardia, renal failure acute. Dafalgan dosage: Unk 6x/days.
Multiple prescriptions taken:
  • Celebrex (200 Mg, 1x/day)
  • Lovenox (4000 Iu, 1x/day)
  • Mopral (20 Mg, 1x/day)


Mucosal Induration (7339240-0)
on Feb 25, 2011 Female from SWITZERLAND , 63 years of age, weighting 191.8 lb, was diagnosed with
  • arthralgia
  • hypopituitarism
and was treated with Dafalgan. After Dafalgan was administered, patient encountered several Dafalgan side effects: mucosal induration. Dafalgan dosage: N/A.
Multiple concurrent drugs taken:
  • Eltroxin
  • Hydrocortisone
  • Golimumab
  • Methotrexate
  • Tambocor
  • Golimumab
Patient was hospitalized.

Pruritus, Thrombocytopenia (7336332-7)
Patient was taking Dafalgan. Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: pruritus, thrombocytopenia on Feb 25, 2011 from FRANCE Additional patient health information: Female , 89 years of age, . Dafalgan dosage: Unk.
Associated medications used:
  • Triatec (Unk)
  • Alprazolam (Unk)
  • Inipomp (Unk)
  • Kardegic (Unk)
  • Effexor (Unk)
  • Diamox (Unk)
  • Lasix (Unk)
  • Duphalac (Unk)
Patient was hospitalized.

Somnolence, Respiratory Depression, Coma, Oxygen Saturation Decreased, Toxicity To Various Agents (7311945-7)
Adverse event was reported on Feb 11, 2011 by a Female taking Dafalgan (Dosage: 1 G, 3x/day, Long Term) . Location: SWITZERLAND , 89 years of age, Patient felt the following Dafalgan side effects: somnolence, respiratory depression, coma, oxygen saturation decreased, toxicity to various agents.
Multiple prescriptions taken:
  • Paspertin (10 Mg, 3x/day)
  • Amlodipine Besilate (5 Mg, Qd Long Term)
  • Atarax (25 Mg,1 Per 1 Total)
  • Neurontin (300 Mg, 3x/day For A Long Term)
  • Trittico (50 Mg, 1x/day)
  • Temgesic (0.1 Mg, 3x/day,for A Long Term)
  • Nexium (40 Mg, 1x/day)
  • Calcimagon-d3 (500 Mg, 1x/day, Long Term)
Patient was hospitalized.

Pneumonia, Dyspnoea (7249071-8)
on Jan 19, 2011 Male from UNITED STATES , 39 years of age, weighting 138.9 lb, was treated with Dafalgan. After Dafalgan was administered, patient encountered several Dafalgan side effects: pneumonia, dyspnoea. Dafalgan dosage: N/A.
Multiple concurrent drugs taken:
  • Temesta
  • Pemetrexed Disodium (Day 1 Every 21 Days.last Dose Received On 28-apr-2010)
  • Dexamethasone
  • Sodium Chloride
  • Emend
  • Temgesic
  • Redomex
  • Flagyl
Patient was hospitalized.

Bicytopenia, Neutrophil Count Decreased (7235215-0)
on Jan 12, 2011 Male from FRANCE , 64 years of age, was treated with Dafalgan. Directly after, patient experienced the unwanted or unexpected Dafalgan side effects: bicytopenia, neutrophil count decreased. Dafalgan dosage: 1 G, Qd.
Associated medications used:
  • Sodium Bicarbonate (3 G, Qd)
  • Lasix (40 Mg, Qd)
  • Novomix 30 Flexpen (Unk)
  • Temerit (2.5 Mg, Qd)
  • Calcidose /00108001/ (500 Mg, Qd)
  • Kardegic (75 Mg, Qd)
  • Mopral /00661201/ (Unk)
  • Xatral (10 Mg, Qd)
Patient was hospitalized.

Showing 1-25 of 45 

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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.

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Dafalgan Information

More About Dafalgan

Side Effects reported to FDA: 45. View Dafalgan Adverse Reports

Dafalgan safety alerts: No

Reported deaths: 5

Reported hospitalizations: 19

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