TABLE 1.

Algorithm of causality assessment in reports of the Spanish Pharmacovigilance System (Aguirre and García, 2016).

Drug—adverse reaction/item in the algorithm	Score	Meaning	Observation
Risperidone—hypertransaminasemia
1. Temporal sequence	2/2	Compatible	2 weeks after initiation of the drug: GOT 130 IU/L and GPT 204 IU/L. Not in a previous analysis just before the initiation: GOT 19 IU/L and GPT 11 IU/L
2. Previous knowledge	2/2	Described in the drug data sheet	Described in the drug data sheet as infrequent
3. Outcome after withdrawal	2/2	Improvement with withdrawal	2 weeks after withdrawal of the drug: GOT 30 IU/L and GPT 49 IU/L
4. Re-exposure	0/2	No re-exposure	-
5. Alternative causes	1/1	Sufficient information to rule out other causes	Hepatotropic virus serology negative. No alcohol consumption. No fever, no other symptoms, and no other alterations in laboratory tests
6. Contributing factors	1/1	Yes	CYP2D6 poor metabolizer
7. Additional explorations	0/1	No	Drug plasma levels were not analyzed
Total score	8/11	Defined	-
Pimozide—parkinsonism
1. Temporal sequence	2/2	Compatible	Onset some months after initiation of the drug. Rapid worsening after dose increase
2. Previous knowledge	2/2	Described in the drug data sheet	-
3. Outcome after withdrawal	2/2	Improvement with withdrawal	Rapid and progressive improvement after withdrawal
4. Re-exposure	0/2	No re-exposure	-
5. Alternative causes	1/1	Sufficient information to rule out other causes	Brain computed tomography and DAT-SCAN without alterations
6. Contributing factors	1/1	Yes	CYP2D6 poor metabolizer
7. Additional explorations	0/1	No	Drug plasma levels were not analyzed
Total score	8/11	Defined	-