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Soriatane (Acitretin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Soriatane (Acitretin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (74)
Death (5)
Life Threatening Events (2)
Disability (6)

Reports by Reaction Type

Drug Ineffective (8)Alopecia (8)Pruritus (6)Skin Exfoliation (6)Erythema (6)Acne (5)Chapped Lips (5)Vision Blurred (5)Chills (4)Psoriasis (4)Visual Acuity Reduced (4)Headache (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Soriatane (Acitretin). For a complete list or a specific selection of reports, please use the links above.

Possible Soriatane side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male

Reactions: Swelling, Nasal Dryness, Traumatic Haematoma, Haematoma

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Methotrexate



Possible Soriatane side effects in male

Reported by a physician from France on 2012-08-23

Patient: male

Reactions: Toxic Skin Eruption, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Daivobet; Locapred; ART 50; Locoid; Diprosalic; Diprosone



Possible Soriatane side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: male

Reactions: Haematoma

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Methotrexate



Possible Soriatane side effects in 64 year old male

Reported by a physician from United States on 2012-08-17

Patient: 64 year old male

Reactions: Visual Acuity Reduced, Retinal Artery Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Enbrel
    Dosage: 50mg weekly
    Indication: Psoriasis
    Start date: 2012-01-01

Soriatane
    Dosage: 20mg see dosage text
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2012-05-02
    End date: 2012-07-10

Other drugs received by patient: Diovan; Narrowband UV-B Phototherapy; Aspirin; M.v.i.; Ascorbic Acid; Vitamin D; Ibuprofen



Possible Soriatane side effects in 22 year old female

Reported by a physician from United States on 2012-08-16

Patient: 22 year old female

Reactions: Maternal Exposure Before Pregnancy

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Birth Control Pills



Possible Soriatane side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: male

Reactions: B-Cell Lymphoma, Drug Ineffective, Toxic Epidermal Necrolysis

Adverse event resulted in: death

Drug(s) suspected as cause:
Allopurinol
    Indication: Tumour Lysis Syndrome
    End date: 2011-07-01

Cyclosporine
    Indication: Psoriasis
    Start date: 2011-06-01
    End date: 2011-07-01

Humira
    Indication: Psoriasis
    End date: 2011-06-01

Remicade
    Indication: Psoriasis
    Start date: 2011-06-01
    End date: 2011-07-01

Soriatane
    Indication: Psoriasis
    Start date: 2011-06-01
    End date: 2011-07-01



Possible Soriatane side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: female

Reactions: Blood Alkaline Phosphatase Increased, Hypercholesterolaemia, Microcytic Anaemia, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effexor
    Dosage: 75mg three times per day
    Administration route: Oral
    Indication: Depression

Nozinan
    Dosage: 25mg per day
    Administration route: Oral
    Indication: Depression

Soriatane
    Dosage: 10mg per day
    Administration route: Oral
    Start date: 2011-11-30
    End date: 2012-02-13

Soriatane
    Dosage: 20mg per day
    Administration route: Oral
    Indication: Ichthyosis
    End date: 2011-11-29

Sulfarlem

Trimeprazine Tartrate
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Depression

Other drugs received by patient: Oxazepam; Duphaston; Fenofibrate; Atarax; Retinol; Cetirizine; Havlane; Primperan TAB; Sulfarlem; Transipeg; Nexium; Stresam; Morphine Sulfate; Morphine Sulfate; Zopiclone; Artificial Tears



Possible Soriatane side effects in 48 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09

Patient: 48 year old female

Reactions: General Physical Health Deterioration, Microcytic Anaemia, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effexor XR
    Dosage: 75 mg, 3x/day
    Administration route: Oral
    Indication: Depression

Nozinan
    Dosage: 25 mg, daily
    Administration route: Oral
    Indication: Depression

Soriatane
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2011-11-30
    End date: 2012-02-13

Soriatane
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Ichthyosis
    End date: 2011-11-29

Theralene
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Depression

Other drugs received by patient: Duphaston; Fenofibrate; Atarax; Transipeg; Havlane; Sulfarem; Nexium; Oxazepam; Zopiclone; Vitamin A; Primperan TAB; Cetirizine; Stresam



Possible Soriatane side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 64 year old male

Reactions: Visual Acuity Reduced, Retinal Artery Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: M.v.i.; Vitamin D; Aspirin; Diovan; Ibuprofen; Enbrel; Ascorbic Acid



Possible Soriatane side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 49 year old male

Reactions: Chills, Dermatitis Exfoliative

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Prednisone; Cyclosporine



Possible Soriatane side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Oncologic Complication

Adverse event resulted in: death

Drug(s) suspected as cause:
Soriatane



Possible Soriatane side effects in 64 year old male

Reported by a physician from United States on 2012-07-18

Patient: 64 year old male

Reactions: Visual Acuity Reduced, Retinal Artery Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Ascorbic Acid; Enbrel; Vitamin D; M.v.i.; Aspirin; Ibuprofen; Diovan



Possible Soriatane side effects in male

Reported by a physician from United States on 2012-07-18

Patient: male

Reactions: B-Cell Lymphoma, Drug Ineffective, Toxic Epidermal Necrolysis

Adverse event resulted in: death

Drug(s) suspected as cause:
Allopurinol
    Indication: Tumour Lysis Syndrome
    Start date: 2011-01-01
    End date: 2011-07-01

Allopurinol
    Indication: Prophylaxis

Cyclosporine
    Indication: Psoriasis
    Start date: 2011-06-01
    End date: 2011-07-01

Humira
    Indication: Psoriasis
    End date: 2011-06-01

Infliximab
    Indication: Psoriasis
    Start date: 2011-06-01
    End date: 2011-07-01

Soriatane
    Indication: Psoriasis
    Start date: 2011-06-01
    End date: 2011-07-01



Possible Soriatane side effects in male

Reported by a health professional (non-physician/pharmacist) from Algeria on 2012-07-09

Patient: male

Reactions: Lymphadenopathy, Oedema Peripheral, Visual Acuity Reduced, Musculoskeletal Stiffness, Asthenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Soriatane



Possible Soriatane side effects in 40 year old male

Reported by a physician from France on 2012-07-02

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Baclofen
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Dantrium
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01
    End date: 2012-02-01

Isotretinoin
    Administration route: Oral
    Indication: Acne
    Start date: 2011-12-13

Sertraline Hydrochloride
    Dosage: 1ud per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01

Soriatane
    Administration route: Oral
    Indication: Dermatosis
    Start date: 2011-08-15
    End date: 2011-12-13

Trospium Chloride
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Soriatane side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 49 year old male

Reactions: Chills, Dermatitis Exfoliative

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Prednisone



Possible Soriatane side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-25

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Baclofen
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Dantrium
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01
    End date: 2012-02-01

Isotretinoin
    Administration route: Oral
    Indication: Acne
    Start date: 2011-12-13

Sertraline Hydrochloride
    Dosage: 1ud per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01

Soriatane
    Administration route: Oral
    Indication: Dermatosis
    Start date: 2011-08-15
    End date: 2011-12-13

Trospium Chloride
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Soriatane side effects in 66 year old male

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: 66 year old male

Reactions: Osteonecrosis

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Lisinopril; Fluticasone Furoate



Possible Soriatane side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: 44 year old male, weighing 74.8 kg (164.6 pounds)

Reactions: Pustular Psoriasis, Psoriasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol

Soriatane

Other drugs received by patient: Cortisone Shots



Possible Soriatane side effects in 83 year old female

Reported by a physician from France on 2012-04-30

Patient: 83 year old female

Reactions: Cheilitis, Intertrigo, Skin Ulcer, Rash Erythematous, Conjunctivitis, Rash Pruritic, Skin Plaque

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 100 mg;qd;po
    Administration route: Oral
    Indication: Hyperuricaemia
    Start date: 2012-02-11
    End date: 2012-02-13

Allopurinol
    Dosage: 100 mg;qd;po
    Administration route: Oral
    Indication: Gout
    Start date: 2012-02-11
    End date: 2012-02-13

Amycor (Amycor / 01609101 / )
    Dosage: cut
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-12

Diprosone
    Dosage: cut
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-21

Econazole Nitrate
    Dosage: cut
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-21

Soriatane
    Dosage: 30 mg;qd
    Indication: Psoriasis
    Start date: 2012-01-01
    End date: 2012-02-16

Other drugs received by patient: Lasix; Ramipril; Vitabact; Levothyroxine Sodium; Silver Sulfadiazine; Potassium Chloride; Nitroglycerin; Hyperium; Colchicine; Acetaminophen; Vitamin C; Locoid; Bisoprolol Fumarate; Ferrous Fumarate; Pantoprazole Sodium



Possible Soriatane side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-19

Patient: 40 year old male

Reactions: Acne

Drug(s) suspected as cause:
Baclofen
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Dantrium
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Isotretinoin
    Administration route: Oral
    Indication: Acne
    Start date: 2011-12-13

Sertraline Hydrochloride
    Dosage: 1ud per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01

Soriatane
    Administration route: Oral
    Indication: Dermatosis
    Start date: 2011-08-15
    End date: 2011-12-13

Trospium Chloride
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01



Possible Soriatane side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Nausea, Presyncope, Vision Blurred

Drug(s) suspected as cause:
Soriatane



Possible Soriatane side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: female

Reactions: Exposure VIA Semen, Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Soriatane



Possible Soriatane side effects in 43 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-03

Patient: 43 year old male

Reactions: Haemorrhoid Operation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Soriatane



Possible Soriatane side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: 85 year old female

Reactions: Death, Aortic Bypass, Alopecia, Post Procedural Complication, Nail Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Levothyroxine Sodium; Simvastatin; Lisinopril



Possible Soriatane side effects in 65 year old male

Reported by a physician from United States on 2012-03-14

Patient: 65 year old male, weighing 81.8 kg (180.0 pounds)

Reactions: Alcohol Withdrawal Syndrome, Delirium Tremens, Chills, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alcohol
    Indication: Product Used FOR Unknown Indication

Soriatane
    Dosage: 25mg five times per week
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2012-02-01
    End date: 2012-02-01



Possible Soriatane side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2012-02-01

Patient: 27 year old female

Reactions: Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Soriatane



Possible Soriatane side effects in male

Reported by a physician from France on 2012-01-31

Patient: male

Reactions: Myalgia, Rhabdomyolysis, Blood Creatine Phosphokinase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: Gaviscon; Lansoprazole; Nexium



Possible Soriatane side effects in 54 year old male

Reported by a physician from United States on 2012-01-29

Patient: 54 year old male

Reactions: Drug Dose Omission, Blood Cholesterol Increased, Facial Bones Fracture, Psoriasis, Laceration, Ear Congestion

Drug(s) suspected as cause:
Humira
    Indication: Psoriasis
    Start date: 2007-12-01

Soriatane
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspirin; Lisinopril



Possible Soriatane side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-01-20

Patient: 54 year old female, weighing 61.4 kg (135.1 pounds)

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Soriatane

Other drugs received by patient: NO Concurrent Medication

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