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

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Showing 1-25 of 29 

Flushing, Dyspnoea, Erythema, Infusion Related Reaction, Oxygen Saturation Decreased, Blood Pressure Increased, Tachycardia (8461811-9)
on Jun 14, 2012 Female from GREECE , 49 years of age, weighting 185.2 lb, was treated with Fenistil. Directly after, patient experienced the unwanted or unexpected Fenistil side effects: flushing, dyspnoea, erythema, infusion related reaction, oxygen saturation decreased, blood pressure increased, tachycardia. Fenistil dosage: N/A.
Associated medications used:
  • Remicade (4 Vials For Each Of The First Three Infusions)
  • Cortisone Acetate
  • Remicade (Fourth Infusion, Received 5 Vials)
  • Remicade (4 Vials)
  • Remicade (Fifth Infusion, Received 5 Vials)


Cerebrovascular Accident, Hemianopia, Chylothorax, Infarction (8384183-7)
Patient was taking Fenistil. Patient felt the following Fenistil side effects: cerebrovascular accident, hemianopia, chylothorax, infarction on Nov 22, 2011 from GERMANY Additional patient health information: Male , weighting 209.4 lb, . Fenistil dosage: N/A.
Multiple prescriptions taken:
  • Bendamustina
  • Valaciclovir
  • Cotrim Ds
  • Rituximab
  • Pantoprazole
  • Ranitidine Hcl
  • Dexamethasone
Patient was hospitalized and became disabled.

(8362124-6)
Adverse event was reported on May 10, 2012 by a Female taking Fenistil (Dosage: 1 Mg In The Evening) was diagnosed with
  • skin disorder
and. Location: GERMANY , 48 years of age, weighting 83.78 lb, .
Multiple concurrent drugs taken:
  • Cetirizine (10mg In The Morning)


Tumour Haemorrhage (8282981-1)
on Apr 04, 2012 Male from GERMANY , 59 years of age, weighting 134.0 lb, was treated with Fenistil. Directly after, patient experienced the unwanted or unexpected Fenistil side effects: tumour haemorrhage. Fenistil dosage: N/A.
Associated medications used:
  • Docetaxel
  • Cisplatin
  • Docetaxel
  • Fluorouracil
  • Cetuximab
  • Dexamethasone
  • Granisetron Hydrochloride



Gastrointestinal Haemorrhage (8196811-X)
on Mar 01, 2012 Female from GERMANY , 58 years of age, weighting 154.3 lb, was treated with Fenistil. Patient felt the following Fenistil side effects: gastrointestinal haemorrhage. Fenistil dosage: 4 Mg, Unk.
Multiple prescriptions taken:
  • Metoprolol Tartrate (190 Mg, Half A Tablet Daily)
  • Temsirolimus (25 Mg, 1x/day)
  • Amlodipine Besylate And Valsartan (10 / 160 Mg)
  • Dexamethasone (8 Mg, Unk)
  • Novalgin (30 Gtt, 3x/day)
  • Insulin Detemir (10 Iu, Unk)
Patient was hospitalized.

Neoplasm Progression, Renal Failure, Neoplasm Malignant (8195538-8)
Patient was taking Fenistil. After Fenistil was administered, patient encountered several Fenistil side effects: neoplasm progression, renal failure, neoplasm malignant on Mar 06, 2012 from GERMANY Additional patient health information: Male , weighting 231.5 lb, . Fenistil dosage: N/A.
Multiple concurrent drugs taken:
  • Torisel (25 Mg,)
  • Zometa (4 Mg Every 4 Weeks)
Patient was hospitalized.

Herpes Oesophagitis, Pneumonia, Neoplasm Progression (8115830-2)
Adverse event was reported on Feb 01, 2012 by a Male taking Fenistil (Dosage: N/A) was diagnosed with
  • pruritus
  • pain
  • non-small cell lung cancer stage iv
  • hypothyroidism
  • metastases to bone
and. Location: GERMANY , weighting 156.5 lb, Directly after, patient experienced the unwanted or unexpected Fenistil side effects: herpes oesophagitis, pneumonia, neoplasm progression.
Associated medications used:
  • Ibuprofen
  • Pemetrexed (950 Mg, Other)
  • Levothyroxine Sodium
  • Zometa
  • Necitumumab (11f8) (ly3012211) (800 Mg, Other)
  • Pantoprazole (Unk, Unk)
  • Vitamin B-12
  • Cisplatin (143 Mg, Other)
Patient was hospitalized.

Epilepsy, Convulsion, Urinary Tract Infection, Hypocalcaemia, Pyrexia, Blood Calcium Decreased, Cerebrovascular Accident (8105724-0)
on Jan 27, 2012 Male from GERMANY , 82 years of age, was treated with Fenistil-retard. Patient felt the following Fenistil side effects: epilepsy, convulsion, urinary tract infection, hypocalcaemia, pyrexia, blood calcium decreased, cerebrovascular accident. Fenistil-retard dosage: Unk Unk, Qd.
Multiple prescriptions taken:
  • Calcium Beta (Unk Unk, Qd)
  • Calcium Acetate (1000 Mg, Qd)
  • Furosemide (Unk Unk, Bid)
  • Tegretol (Unk Unk, Qd)
  • Prolia (60 Mg, Q6mo)
  • Levothyroxine Sodium (Unk Unk, Qd)
  • Nitroglycerin (Unk Unk, Prn)
  • Tamsulosin Hexal (0.4 Mg, Qd)
Patient was hospitalized.

Femur Fracture, Neoplasm Malignant, Sepsis, Neoplasm Progression (8073217-5)
on Jan 20, 2012 Male from GERMANY , weighting 220.5 lb, was treated with Fenistil. After Fenistil was administered, patient encountered several Fenistil side effects: femur fracture, neoplasm malignant, sepsis, neoplasm progression. Fenistil dosage: 4 Mg, Unk.
Multiple concurrent drugs taken:
  • Zometa (4 Mg Every 4 Weeks)
  • Ranitidine Hcl (50 Mg, Unk)
  • Zometa (4 Mg Every 4 Weeks)
  • Torisel (25 Mg, 6 Cycles)


Sepsis, Femur Fracture (8057199-8)
Patient was taking Fenistil. Directly after, patient experienced the unwanted or unexpected Fenistil side effects: sepsis, femur fracture on Jan 12, 2012 from GERMANY Additional patient health information: Male , weighting 220.5 lb, . Fenistil dosage: 4 Mg, Unk.
Associated medications used:
  • Ranitidine Hcl (50 Mg, Unk)
  • Zometa (4 Mg Every 4 Weeks)
  • Zometa (4 Mg Every 4 Weeks)
  • Torisel (25 Mg, 6 Cycles)


(8008089-8)
Adverse event was reported on Dec 22, 2011 by a Male taking Fenistil (Dosage: 4 Mg, Unk) . Location: GERMANY , weighting 220.5 lb, .
Multiple prescriptions taken:
  • Zometa (4 Mg Every 4 Weeks)
  • Ranitidine Hcl (50 Mg, Unk)
  • Zometa (4 Mg Every 4 Weeks)
  • Torisel (25 Mg, 6 Cycles)


Pneumonia, Neutropenia, Herpes Oesophagitis, Neoplasm Malignant, Abdominal Pain Upper (7954469-6)
on Nov 30, 2011 Male from UNITED STATES , 67 years of age, weighting 156.5 lb, was treated with Fenistil. After Fenistil was administered, patient encountered several Fenistil side effects: pneumonia, neutropenia, herpes oesophagitis, neoplasm malignant, abdominal pain upper. Fenistil dosage: N/A.
Multiple concurrent drugs taken:
  • Zometa
  • Allopurinol
  • Vitamin B-12
  • Alimta (Last Inf:04jan2011 No Of Inf:3)
  • Ibuprofen
  • Folsan
  • Levothyroxine Sodium
  • Necitumumab (Last Inf:10jan2011 No Of Inf:6)
Patient was hospitalized.

Renal Failure Acute (7916564-7)
on Nov 02, 2011 Female from GERMANY , 76 years of age, weighting 194.0 lb, was treated with Fenistil. Directly after, patient experienced the unwanted or unexpected Fenistil side effects: renal failure acute. Fenistil dosage: Unk.
Associated medications used:
  • Taxol (100-160 Mg)
  • Ondanestron (Unk)
  • Ranitidine (Unk)
Patient was hospitalized.

Hypoaesthesia Oral, Loss Of Consciousness (7844114-2)
Patient was taking Fenistil. Patient felt the following Fenistil side effects: hypoaesthesia oral, loss of consciousness on Oct 12, 2011 from GERMANY Additional patient health information: Female , 54 years of age, . Fenistil dosage: Unk.
Multiple prescriptions taken:
  • Aspirin
Patient was hospitalized.

Depression, Suicide Attempt (7763460-4)
Adverse event was reported on Sep 14, 2011 by a Male taking Fenistil (Dosage: 1 Mg, Prior To Temsirolimus Administration) . Location: GERMANY , 96 years of age, weighting 143.3 lb, After Fenistil was administered, patient encountered several Fenistil side effects: depression, suicide attempt.
Multiple concurrent drugs taken:
  • Ranitidine (50 Mg, Prior To Temsirolimus Administration)
  • Clopidogrel (75 Mg, Unk)
  • Aspirin (100 Mg, Unk)
  • Temsirolimus (175 Mg, Single)
  • Temsirolimus (100 Mg, Single)
  • Temsirolimus (150 Mg, Single)
  • Temsirolimus
Patient was hospitalized.

Pancreatitis Haemorrhagic, Circulatory Collapse, Pneumonia (7752661-7)
on Sep 08, 2011 Female from GERMANY , weighting 154.3 lb, was treated with Fenistil (dimetindene). Directly after, patient experienced the unwanted or unexpected Fenistil side effects: pancreatitis haemorrhagic, circulatory collapse, pneumonia. Fenistil (dimetindene) dosage: N/A.
Associated medications used:
  • Ranitidine Hcl
  • Avastin (First Line)
  • Paclitaxel (First Line)
  • Dexamethasone


Chest Discomfort, Pleural Effusion, Pain In Extremity, Dyspnoea Exertional, Nightmare, Fibrin D Dimer Increased (7630690-1)
on Jul 12, 2011 Female from UNITED KINGDOM , 59 years of age, weighting 165.3 lb, was treated with Fenistil (dimetindene). Patient felt the following Fenistil side effects: chest discomfort, pleural effusion, pain in extremity, dyspnoea exertional, nightmare, fibrin d dimer increased. Fenistil (dimetindene) dosage: 4 Mg, Unk.
Multiple prescriptions taken:
  • Tilidin (100 Mg, Unk)
  • Prednisolone (250 Mg, Unk)
  • Methylprednisolone Acetate (125 Mg, Unk)
  • Novalgin (40 Gtt, Unk)
  • Rituximab (1000 Mg, Unk)
  • Methylprednisolone Acetate (500 Mg, Unk)
  • Adalimumab (1000 Mg, Unk)
  • Methylprednisolone Acetate (250 Mg, Unk)
Patient was hospitalized.

Renal Failure Acute (7540093-6)
Patient was taking Fenistil, 1 Mg, Drg, Novartis. After Fenistil was administered, patient encountered several Fenistil side effects: renal failure acute on May 31, 2011 from GERMANY Additional patient health information: Male , 70 years of age, weighting 169.8 lb, . Fenistil, 1 Mg, Drg, Novartis dosage: Exceptin 08 Jan 2011: 1x1, Break: 09 Jan 2011.
Multiple concurrent drugs taken:
  • Midazolam, Amp, Nn (1x5 Mg I.v. On 02 Jan 2011 And 4.5 Mg On 13 Jan 2011)
  • Ramipril (2.5 Milligram; Break: 03 Jan 2011)
  • Zinacef (1.5-3 G Daily I.v.)
  • Protaphane, Amp, Novo Nordisk
  • Sobelin, 600 Mg, Amp, Pfizer (600-1200 Mg Daily I.v.)
  • Gentamicin (240 Mg Daily I.v., Excepting 03 Jan 2011: 80 Mg And 04 Jan 2011: 160 Mg)
  • Fraxiparin, 0,3 Ml, Amp, Gsk (1x2850 Iu Daily S.c., Break: 10-15 Jan 2011)
Patient was hospitalized.

Alopecia (7469972-5)
Adverse event was reported on May 06, 2011 by a Female taking Fenistil (dimetindene) (Dosage: N/A) . Location: GERMANY , weighting 165.3 lb, Directly after, patient experienced the unwanted or unexpected Fenistil side effects: alopecia.
Associated medications used:
  • Herceptin


Urosepsis, Upper Respiratory Tract Infection, Progressive Multifocal Leukoencephalopathy (7268918-2)
on Jan 17, 2011 Male from UNITED KINGDOM , weighting 158.7 lb, was diagnosed with
  • prophylaxis
  • waldenstrom's macroglobulinaemia
and was treated with Fenistil. Patient felt the following Fenistil side effects: urosepsis, upper respiratory tract infection, progressive multifocal leukoencephalopathy. Fenistil dosage: 4 Mg, Unk.
Multiple prescriptions taken:
  • Bendamustine (100 Mg/m2, Unk)
  • Paracetamol (1000 Mg, Unk)
  • Prednisolone (100 Mg, Unk)
  • Mabthera (375 Mg/m2, Q4w)
  • Fortecortin (8 Mg, Unk)


Oesophageal Candidiasis, Pustular Psoriasis, Helicobacter Infection, Dysaesthesia (7226515-9)
on Jan 04, 2011 Male from GERMANY , 59 years of age, weighting 211.6 lb, was treated with Fenistil. After Fenistil was administered, patient encountered several Fenistil side effects: oesophageal candidiasis, pustular psoriasis, helicobacter infection, dysaesthesia. Fenistil dosage: N/A.
Multiple concurrent drugs taken:
  • Pantozol
  • Remergil
  • Remicade
  • Pravastatin Sodium
  • Enalapril
  • Remicade
Patient was hospitalized.

Stevens-johnson Syndrome, Toxic Epidermal Necrolysis (5646787-1)
Patient was taking Fenistil (nch)(dimetindene Maleate) Ampoule. Directly after, patient experienced the unwanted or unexpected Fenistil side effects: stevens-johnson syndrome, toxic epidermal necrolysis on Feb 22, 2008 from GERMANY Additional patient health information: Male , 62 years of age, was diagnosed with
  • rash
and. Fenistil (nch)(dimetindene Maleate) Ampoule dosage: 1 Df, Tid; Intravenous, 1 Df, Tid, Intravenous. Patient was hospitalized.

Stevens-johnson Syndrome, Toxic Epidermal Necrolysis (5635635-1)
Adverse event was reported on Feb 04, 2008 by a Male taking Fenistil (nch)(dimetindene Maleate) Ampoule (Dosage: 1 Df, Tid, Intravenous) was diagnosed with
  • rash
and. Location: GERMANY , 62 years of age, Patient felt the following Fenistil side effects: stevens-johnson syndrome, toxic epidermal necrolysis. Patient was hospitalized.

Stevens-johnson Syndrome, Toxic Epidermal Necrolysis (5633183-6)
on Feb 04, 2008 Male from GERMANY , 76 years of age, was diagnosed with
  • pruritus
and was treated with Fenistil (dimetindene Maleate). After Fenistil was administered, patient encountered several Fenistil side effects: stevens-johnson syndrome, toxic epidermal necrolysis. Fenistil (dimetindene Maleate) dosage: 2 Df, Bid, Oral; 2 Df, Tid, Oral. Patient was hospitalized.

Rhinitis Allergic, Toxic Epidermal Necrolysis (5607510-X)
on Jan 14, 2008 Male from GERMANY , 54 years of age, was diagnosed with
  • rhinitis allergic
and was treated with Fenistil-retard. Directly after, patient experienced the unwanted or unexpected Fenistil side effects: rhinitis allergic, toxic epidermal necrolysis. Fenistil-retard dosage: Oral.
Associated medications used:
  • Clonidine (clonidine Hydrochloride) (150 Mg, Tid)
  • Pantoprazole Sodium (40 Mg, Qd, Oral)
  • Decortin (prednisone) (60 Mg, Qd, Oral)
  • Broncho (salbutamol) (2 Df, Bid)
  • Aquaphor (xipamide) (40 Mg, Bid, Oral)
  • Osyrol (spironolactone) (100 Mg, Bid, Oral)
  • Vian (fluticasone Propionate, Salmeterol Xinafoate) (1 Df, Bid)
  • Allopurinol (100 Mg, Qd, Oral)
Patient was hospitalized.

Showing 1-25 of 29 

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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.

Fenistil Information

More About Fenistil

Side Effects reported to FDA: 29. View Fenistil Adverse Reports

Fenistil safety alerts: No

Reported deaths: 10

Reported hospitalizations: 9

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