Trental (Pentoxifylline) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical trials were conducted using either extended-release TRENTAL tablets for up to 60 weeks or immediate-release TRENTAL capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200–400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release TRENTAL tablets, immediate-release TRENTAL capsules, or the corresponding placebos. The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S.

The table indicates that in the tablet studies few patients discontinued because of adverse effects.

INCIDENCE (%) OF SIDE EFFECTS

	Extended-Release Tablets		Immediate-Release Capsules
	Commercially Available		Used only for Controlled Clinical Trials
	TRENTAL	Placebo	TRENTAL	Placebo
(Numbers of Patients at Risk)	(321)	(128)	(177)	(138)
Discontinued for Side Effect	3.1	0	9.6	7.2
CARDIOVASCULAR SYSTEM
Angina/Chest Pain	0.3	-	1.1	2.2
Arrhythmia/Palpitation	-	-	1.7	0.7
Flushing	-	-	2.3	0.7
DIGESTIVE SYSTEM
Abdominal Discomfort	-	-	4.0	1.4
Belching/Flatus/Bloating	0.6	-	9.0	3.6
Diarrhea	-	-	3.4	2.9
Dyspepsia	2.8	4.7	9.6	2.9
Nausea	2.2	0.8	28.8	8.7
Vomiting	1.2	-	4.5	0.7
NERVOUS SYSTEM
Agitation/Nervousness	-	-	1.7	0.7
Dizziness	1.9	3.1	11.9	4.3
Drowsiness	-	-	1.1	5.8
Headache	1.2	1.6	6.2	5.8
Insomnia	-	-	2.3	2.2
Tremor	0.3	0.8	-	-
Blurred Vision	-	-	2.3	1.4

TRENTAL has been marketed in Europe and elsewhere since 1972. In addition to the above symptoms, the following have been reported spontaneously since marketing or occurred in other clinical trials with an incidence of less than 1%; the causal relationship was uncertain:

•     Cardiovascular - dyspnea, edema, hypotension.
•     Digestive - anorexia, cholecystitis, constipation, dry mouth/thirst.
•     Nervous - anxiety, confusion, depression, seizures, aseptic meningitis.
•     Respiratory - epistaxis, flu-like symptoms, laryngitis, nasal congestion.
•     Skin and Appendages - brittle fingernails, pruritus, rash, urticaria, angioedema.
•     Special Senses - blurred vision, conjunctivitis, earache, scotoma.
•     Miscellaneous - bad taste, excessive salivation, leukopenia, malaise, sore throat/swollen neck glands, weight change.

A few rare events have been reported spontaneously worldwide since marketing in 1972. Although they occurred under circumstances in which a causal relationship with pentoxifylline could not be established, they are listed to serve as information for physicians. Cardiovascular — angina, arrhythmia, tachycardia, anaphylactoid reactions. Digestive — hepatitis, jaundice, increased liver enzymes; and Hemic and Lymphatic — decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia.

REPORTS OF SUSPECTED TRENTAL SIDE EFFECTS / ADVERSE REACTIONS

Possible Trental side effects / adverse reactions in 79 year old male

Reported by a physician from Italy on 2011-12-06

Patient: 79 year old male

Reactions: Pain, Hypotension, Dizziness, Hyponatraemia, Bradyphrenia, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Ramipril
    Administration route: Oral
    Start date: 2008-01-01

Lasix
    Administration route: Oral
    Start date: 2008-01-01

Lamivudine
    Administration route: Oral
    Start date: 2008-01-01

Tramadol HCL
    Administration route: Oral
    Start date: 2008-01-01
    End date: 2011-09-06

Prednisone
    Administration route: Oral
    Start date: 2008-01-01

Omeprazole
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2008-01-01

Plaquenil
    Administration route: Oral
    Start date: 2008-01-01

Trental
    Administration route: Oral
    Start date: 2008-01-01

Other drugs received by patient: Acetylsalicylic Acid SRT; Tiopronin

Possible Trental side effects / adverse reactions in male

Reported by a physician from Italy on 2011-12-12

Patient: male

Reactions: Hypotension, Hyponatraemia, Bradyphrenia, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Prednisone TAB
    Administration route: Oral
    Indication: Connective Tissue Disorder
    Start date: 2008-01-01

Ramipril
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-01-01

Plaquenil
    Administration route: Oral
    Indication: Connective Tissue Disorder
    Start date: 2008-01-01
    End date: 2011-09-06

Tramadol HCL
    Administration route: Oral
    Indication: Analgesic Therapy
    Start date: 2008-01-01

Trental
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-01-01

Lasix
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-01-01

Lamivudine
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2008-01-01

Omeprazole
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2008-01-01

Other drugs received by patient: Acetylsalicylic Acid SRT; Spiriva Respimat

Possible Trental side effects / adverse reactions in 79 year old male

Reported by a physician from Italy on 2011-12-14

Patient: 79 year old male

Reactions: Hypotension, Pain, Inappropriate Antidiuretic Hormone Secretion, Dizziness, Hyponatraemia, Bradyphrenia, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Ramipril
    Administration route: Oral
    Start date: 2008-01-01

Trental
    Administration route: Oral
    Start date: 2008-01-01

Plaquenil
    Administration route: Oral
    Start date: 2008-01-01

Prednisone TAB
    Administration route: Oral
    Start date: 2008-01-01

Omeprazole
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2008-01-01

Lasix
    Administration route: Oral
    Start date: 2008-01-01

Tramadol HCL
    Administration route: Oral
    Start date: 2008-01-01
    End date: 2011-09-06

Lamivudine
    Administration route: Oral
    Start date: 2008-01-01

Other drugs received by patient: Tiopronin; Acetylsalicylic Acid SRT