PIMTREA SIDE EFFECTS

SIDE EFFECTS

To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC, Toll-Free at 1- 800-206-7821 or FDA at 1-800-FDA-1088 

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives:

• Thrombophlebitis and venous thrombosis with or without embolism
• Cerebral hemorrhage
• Cerebral thrombosis
• Arterial thromboembolism
• Hypertension
• Pulmonary embolism
• Gallbladder disease
• Myocardial infarction
• Hepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives:

• Mesenteric thrombosis
• Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

• Nausea
• Change in weight (increase or decrease)
• Vomiting
• Change in cervical erosion and secretion
• Gastrointestinal symptoms (such as abdominal cramps and bloating)
• Diminution in lactation when given immediately postpartum
• Breakthrough bleeding
• Cholestatic jaundice
• Spotting
• Migraine
• Change in menstrual flow
• Rash (allergic)
• Amenorrhea
• Mental depression
• Temporary infertility after discontinuation of treatment
• Reduced tolerance to carbohydrates
• Vaginal candidiasis
• Edema
• Change in corneal curvature (steepening)
• Melasma which may persist
• Intolerance to contact lenses
• Breast changes: tenderness, enlargement, secretion

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

• Pre-menstrual syndrome
• Erythema nodosum
• Cataracts
• Hemorrhagic eruption
• Changes in appetite
• Vaginitis
• Cystitis-like syndrome
• Porphyria
• Headache
• Impaired renal function
• Nervousness
• Hemolytic uremic syndrome
• Dizziness
• Acne
• Hirsutism
• Changes in libido
• Loss of scalp hair
• Colitis
• Erythema multiforme
• Budd-Chiari Syndrome