In 2012, crofelemer completed a Phase III trial, and it was approved in December 2012 by the FDA for the indication "symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy".The drug substance is manufactured by Glenmark Pharmaceuticals, and is manufactured as 125 mg delayed-release tablets by Patheon Pharmaceuticals Inc. for Napo Pharmaceuticals. References
External links
"Crofelemer". Drug Information Portal. U.S. National Library of Medicine.
Side effects may include:

Psychological
Depression or even suicidal ideation, as well as nightmares
Apathy or anhedonia, as well as dysphoria
Anxiety, especially of the social anxiety variant
Decreased alertness, awareness, and wakefulness
Impaired attention, focus, and concentration
Decreased desire, drive, and motivation
Fatigue or lethargy or malaise or lassitude
Sedation or drowsiness or somnolence or sleepiness
Agitation or restlessness
Cognitive and memory impairment
Derealization or depersonalization, as well as mild psychosis
Sexual dysfunction including impaired libido, desire, and drive
Physiological
Dizziness, lightheadedness, or vertigo
Miosis or pupil constriction
Xerostomia or dry mouth
Gastrointestinal disturbances such as diarrhea or constipation
Headache or migraine
Myalgia or muscle aches, arthralgia or joint pain, or paresthesia ("pins and needles")
Restless legs syndrome (RLS)
Parkinsonian symptoms such as muscle tremors, rigidity, hypokinesia, or balance or postural instability
Akathisia, ataxia, dyskinesia as well as even tardive dyskinesia, or dystonia
Bells palsy or facial paralysis
Sexual dysfunction consisting of impaired erectile dysfunction or anorgasmia
Hyperprolactinemia or excess prolactin, gynecomastia/breast enlargement in males, or amenorrhoea or absence of menstrual cycles in females
Bradycardia or decreased heart rate
Hypotension or decreased blood pressure (though this may also be considered a therapeutic benefit)
Orthostatic hypotension (also known as postural hypotension)
Hepatitis, hepatotoxicity, or liver dysfunction or damage
Pancreatitis or inflammation of the pancreas
Warm autoimmune hemolytic anemia or deficiency in red blood cells (RBCs)
Myelotoxicity or bone marrow suppression, potentially leading to thrombocytopenia or blood platelet deficiency or leukopenia or white blood cell (WBC) deficiency
Hypersensitivity such as lupus erythematosus, myocarditis, or pericarditis
Lichenoid reactions such as skin lesions or rashes
Pallor

Rebound/withdrawal
Rebound hypertension via withdrawal on account of tolerance upon the abrupt discontinuation of methyldopa has been reported. Mechanism of action
The mechanism of action of methyldopa is not fully clear.