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Soriatane (Acitretin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with SORIATANE Capsules administration resemble those of the hypervitaminosis A syndrome.

Adverse Events/Postmarketing Reports

In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of SORIATANE Capsules. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

Cardiovascular

Acute myocardial infarction, thromboembolism (see WARNINGS), stroke.

Nervous System

Myopathy with peripheral neuropathy has been reported during SORIATANE Capsules therapy. Both conditions improved with discontinuation of the drug.

Psychiatric

Aggressive feelings and/or suicidal thoughts have been reported. These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking SORIATANE Capsules. Since other factors may have contributed to these events, it is not known if they are related to SORIATANE Capsules (see PRECAUTIONS).

Reproductive

Vulvo-vaginitis due to Candida albicans

Skin and Appendages

Thinning of the skin, skin fragility and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed.

Clinical Trials

During clinical trials with SORIATANE Capsules, 513/525 (98%) of patients reported a total of 3545 adverse events. One-hundred sixteen patients (22%) left studies prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three patients died. Two of the deaths were not drug related (pancreatic adenocarcinoma and lung cancer); the other patient died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, SORIATANE Capsules was associated with elevations in liver function test results or triglyceride levels and hepatitis.

The tables below list by body system and frequency the adverse events reported during clinical trials of 525 patients with psoriasis.

Table 3. Adverse Events Frequently Reported During Clinical Trials - Percent of Patients Reporting (N=525)
BODY SYSTEM > 75% 50% to 75% 25% to 50% 10% to 25%
CNS Rigors
Eye Disorders Xerophthalmia
Mucous Membranes CheilitisRhinitis

Dry mouth

Epistaxis

Musculoskeletal

Arthralgia

Spinal hyperostosis

(progression of existing lesions)

Skin and Appendages

Alopecia

Skin peeling

Dry skin

Nail disorder

Pruritus

Erythematous rash

Hyperesthesia

Paresthesia

Paronychia

Skin atrophy

Sticky skin

 

Table 4. Adverse Events Less Frequently Reported During Clinical Trials (Some of Which May Bear No Relationship to Therapy) - Percent of Patients Reporting (N=525)
BODY SYSTEM 1% to 10% < 1%
Body as a Whole

Anorexia

Edema

Fatigue

Hot flashes

Increased

appetite

Alcohol

intolerance

Dizziness

Fever

Influenza-like

symptoms

Malaise

Moniliasis

Muscle weakness

Weight increase

Cardiovascular Flushing

Chest pain

Cyanosis

Increased

bleeding time

Intermittent

claudication

Peripheral

ischemia

CNS (also see Psychiatric)

Headache

Pain

Abnormal gait

Migraine

Neuritis

Pseudotumor

cerebri

(intracranial

hypertension)

Eye Disorders

Abnormal/

blurred vision

Blepharitis

Conjunctivitis/

irritation

Corneal epithelial

abnormality

Decreased night

vision/night

blindness

Eye abnormality

Eye pain

Photophobia

Abnormal

lacrimation

Chalazion

Conjunctival

hemorrhage

Corneal ulceration

Diplopia

Ectropion

Itchy eyes and lids

Papilledema

Recurrent sties

Subepithelial

corneal lesions

Gastrointestinal

Abdominal pain

Diarrhea

Nausea

Tongue disorder

Constipation
Dyspepsia
Esophagitis
Gastritis
Gastroenteritis
Glossitis
Hemorrhoids
Melena
Tenesmus
Tongue ulceration
Liver and Biliary

Hepatic function

abnormal

Hepatitis
Jaundice

Mucous Membranes

Gingival bleeding

Gingivitis

Increased saliva

Stomatitis
Thirst
Ulcerative

stomatitis

Altered saliva
Anal disorder
Gum hyperplasia
Hemorrhage
Pharyngitis
Musculoskeletal

Arthritis

Arthrosis

Back pain

Hypertonia

Myalgia

Osteodynia
Peripheral joint

hyperostosis

(progression of

existing lesions)

Bone disorder
Olecranon bursitis
Spinal hyperostosis

(new lesions)
Tendonitis

Psychiatric

Depression Insomnia

Somnolence

Anxiety
Dysphonia

Libido decreased Nervousness

Reproductive Atrophic vaginitis Leukorrhea
Respiratory Sinusitis

Coughing

Increased sputum

Laryngitis

Skin and Appendages

Abnormal skin

odor

Abnormal hair

texture

Bullous eruption

Cold/clammy

skin

Dermatitis

Increased

sweating

Infection

Psoriasiform rash

Purpura
Pyogenic

granuloma
Rash
Seborrhea
Skin fissures
Skin ulceration
Sunburn

Acne
Breast pain
Cyst
Eczema
Fungal infection
Furunculosis
Hair discoloration
Herpes simplex
Hyperkeratosis
Hypertrichosis
Hypoesthesia
Impaired healing
Otitis media

Otitis externa
Photosensitivity

reaction
Psoriasis aggravated

Scleroderma
Skin nodule
Skin hypertrophy
Skin disorder
Skin irritation
Sweat gland

disorder
Urticaria
Verrucae

Special Senses/ Other

Earache

Taste perversion

Tinnitus

Ceruminosis
Deafness
Taste loss
Urinary Abnormal urine
Dysuria
Penis disorder

 

Laboratory

SORIATANE Capsules therapy induces changes in liver function tests in a significant number of patients. Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 patients treated with SORIATANE Capsules. In most patients, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In patients receiving SORIATANE Capsules during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% (see WARNINGS). Transient, usually reversible elevations of alkaline phosphatase have been observed.

Table 5 lists the laboratory abnormalities reported during clinical trials.

Table 5. Abnormal Laboratory Test Results Reported During Clinical Trials - Percent of Patients Reporting
BODY SYSTEM 50% to 75% 25% to 50% 10% to 25% 1% to 10%
Electrolytes Increased:
–Phosphorus
–Potassium
–Sodium
Decreased:
–Phosphorus
–Potassium
–Sodium

Increased and

decreased:
–Magnesium

Increased and

decreased:
–Calcium
–Chloride

Hematologic Increased:
–Reticulocytes
Decreased:
–Hematocrit
–Hemoglobin
–WBC
Increased:
–Haptoglobin
–Neutrophils
–WBC
Increased:
–Bands
–Basophils
–Eosinophils
–Hematocrit
–Hemoglobin
–Lymphocytes
–Monocytes

Decreased:
–Haptoglobin
–Lymphocytes
–Neutrophils
–Reticulocytes
Increased or

decreased:
–Platelets
–RBC

Hepatic

Increased:
–Cholesterol
–LDH
–SGOT
–SGPT
Decreased:
–HDL

cholesterol

Increased:
–Alkaline

phosphatase
–Direct bilirubin
–GGTP

Increased:
–Globulin
–Total bilirubin
–Total protein
Increased and

decreased:
–Serum albumin

Miscellaneous Increased:
–Triglycerides

Increased:
–CPK
–Fasting blood

sugar

Decreased:
–Fasting blood

sugar
–High occult

blood

Increased and

decreased:
–Iron

Renal Increased:
–Uric acid
Increased:
–BUN
–Creatinine
Urinary WBC in urineAcetonuria
Hematuria
RBC in urine
Glycosuria
Proteinuria

 



REPORTS OF SUSPECTED SORIATANE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Soriatane. The information is not vetted and should not be considered as verified clinical evidence.

Possible Soriatane side effects / adverse reactions in 48 year old female

Reported by a physician from United States on 2011-10-14

Patient: 48 year old female

Reactions: Pruritus, Hypersensitivity, Dermatitis, Skin Disorder, Drug Interaction, Erythema

Adverse event resulted in: hospitalization

Suspect drug(s):
FLU Vaccine
    Indication: Prophylaxis
    Start date: 2010-01-01
    End date: 2010-01-01

Soriatane
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2010-08-01
    End date: 2010-09-01

Other drugs received by patient: Advair Diskus 100/50; Ventolin; Theophylline; Epinephrine; Flonase; Zyrtec; Albuterol; Spironolactone; Benadryl; Diazepam



Possible Soriatane side effects / adverse reactions in 65 year old female

Reported by a physician from United States on 2011-10-31

Patient: 65 year old female

Reactions: Thrombosis, Psoriasis

Adverse event resulted in: hospitalization

Suspect drug(s):
Soriatane



Possible Soriatane side effects / adverse reactions in 70 year old female

Reported by a consumer/non-health professional from United States on 2011-11-17

Patient: 70 year old female

Reactions: Anxiety, DRY Mouth, Alopecia, Chapped Lips, Sticky Skin, Atrial Fibrillation

Suspect drug(s):
Soriatane

Other drugs received by patient: Ramipril; Omeprazole; Atenolol; Vitamin D; Calcium; Pravastatin; Coumadin; Ascorbic Acid; Synthroid



See index of all Soriatane side effect reports >>

Drug label data at the top of this Page last updated: 2009-02-06

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